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Trial record 1 of 1 for:    HIV-V-A004
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Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02315703
Recruitment Status : Active, not recruiting
First Posted : December 12, 2014
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program
Beth Israel Deaconess Medical Center
International AIDS Vaccine Initiative
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Healthy
Interventions Biological: Ad26.Mos.HIV
Biological: MVA-Mosaic
Biological: gp140 DP Low-dose
Biological: gp140 DP High-dose
Drug: Placebo
Enrollment 393
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Period Title: Overall Study
Started 50 49 49 48 49 49 50 49
Completed 44 39 44 39 41 43 37 42
Not Completed 6 10 5 9 8 6 13 7
Reason Not Completed
Adverse Event             0             0             0             1             1             0             1             0
Lost to Follow-up             1             5             3             3             2             1             2             2
Pregnancy             0             0             0             0             0             0             0             1
Withdrawal by Subject             1             3             0             3             4             1             1             2
Physician Decision             0             0             0             0             0             2             1             0
Other             4             2             2             2             1             2             8             2
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo Total
Hide Arm/Group Description Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. Total of all reporting groups
Overall Number of Baseline Participants 50 49 49 48 49 49 50 49 393
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 49 participants 49 participants 48 participants 49 participants 49 participants 50 participants 49 participants 393 participants
29.8  (7.77) 29.6  (7.49) 31.1  (8.22) 29.6  (7.67) 30.3  (7.61) 29.2  (8.73) 30.3  (7.65) 29  (8.06) 29.9  (7.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 49 participants 48 participants 49 participants 49 participants 50 participants 49 participants 393 participants
Female
25
  50.0%
26
  53.1%
28
  57.1%
19
  39.6%
25
  51.0%
19
  38.8%
19
  38.0%
20
  40.8%
181
  46.1%
Male
25
  50.0%
23
  46.9%
21
  42.9%
29
  60.4%
24
  49.0%
30
  61.2%
31
  62.0%
29
  59.2%
212
  53.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 49 participants 48 participants 49 participants 49 participants 50 participants 49 participants 393 participants
Hispanic or Latino
4
   8.0%
6
  12.2%
2
   4.1%
6
  12.5%
3
   6.1%
5
  10.2%
3
   6.0%
6
  12.2%
35
   8.9%
Not Hispanic or Latino
46
  92.0%
43
  87.8%
46
  93.9%
42
  87.5%
46
  93.9%
44
  89.8%
47
  94.0%
43
  87.8%
357
  90.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 49 participants 48 participants 49 participants 49 participants 50 participants 49 participants 393 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.5%
Asian
9
  18.0%
7
  14.3%
9
  18.4%
7
  14.6%
7
  14.3%
8
  16.3%
8
  16.0%
9
  18.4%
64
  16.3%
Black or African American
27
  54.0%
29
  59.2%
27
  55.1%
27
  56.3%
26
  53.1%
26
  53.1%
32
  64.0%
25
  51.0%
219
  55.7%
More than one race
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.1%
1
   2.0%
0
   0.0%
3
   0.8%
White
14
  28.0%
13
  26.5%
11
  22.4%
14
  29.2%
15
  30.6%
13
  26.5%
9
  18.0%
15
  30.6%
104
  26.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 49 participants 48 participants 49 participants 49 participants 50 participants 49 participants 393 participants
RWANDA
7
  14.0%
7
  14.3%
10
  20.4%
8
  16.7%
9
  18.4%
6
  12.2%
5
  10.0%
6
  12.2%
58
  14.8%
SOUTH AFRICA
7
  14.0%
10
  20.4%
5
  10.2%
7
  14.6%
5
  10.2%
7
  14.3%
9
  18.0%
6
  12.2%
56
  14.2%
THAILAND
8
  16.0%
7
  14.3%
7
  14.3%
7
  14.6%
7
  14.3%
7
  14.3%
8
  16.0%
7
  14.3%
58
  14.8%
UGANDA
9
  18.0%
7
  14.3%
8
  16.3%
8
  16.7%
9
  18.4%
10
  20.4%
9
  18.0%
11
  22.4%
71
  18.1%
UNITED STATES
19
  38.0%
18
  36.7%
19
  38.8%
18
  37.5%
19
  38.8%
19
  38.8%
19
  38.0%
19
  38.8%
150
  38.2%
1.Primary Outcome
Title Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination
Hide Description Solicited local AEs (at injection site) included erythema, induration, swelling, itching and warmth were collected within 7 days after vaccination.
Time Frame Up to Week 49 (7 days post any dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 50 49 49 48 49 49 50 49
Measure Type: Number
Unit of Measure: percentage of participants
88.0 83.7 75.5 77.1 77.6 77.6 70.0 57.1
2.Primary Outcome
Title Percentage of Participants With Solicited Systemic Adverse Events (AEs) Post Vaccination
Hide Description Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after vaccination.
Time Frame Up to Week 49 (7 days post any dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 50 49 49 48 49 49 50 49
Measure Type: Number
Unit of Measure: percentage of participants
88.0 85.7 73.5 75.0 87.8 73.5 62.0 59.2
3.Primary Outcome
Title Percentage of Participants With Unsolicited Adverse Events Post Vaccination
Hide Description Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
Time Frame Up to Week 52 (28 days post vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 50 49 49 48 49 49 50 49
Measure Type: Number
Unit of Measure: percentage of participants
80.0 73.5 85.7 87.5 69.4 83.7 86.0 77.6
4.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) Post Vaccination
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 50 49 49 48 49 49 50 49
Measure Type: Count of Participants
Unit of Measure: Participants
5
  10.0%
2
   4.1%
3
   6.1%
4
   8.3%
4
   8.2%
5
  10.2%
2
   4.0%
5
  10.2%
5.Primary Outcome
Title Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28
Hide Description The Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (>) lower limit of quantification (LLOQ) if baseline less than (<) LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline greater than or equal to (>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, and 156.25 endotoxin units per milliliter (EU/mL) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), and Clade C (C97ZA.012) respectively.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol immunogenicity (PPI) analysis set: participants who received at least first 3 vaccines as scheduled, had at least 1 post-vaccination immunogenicity blood draw and not diagnosed with HIV. N(number of participants analyzed): participants who were evaluable for this OM. n(number analyzed): participants evaluable for specified categories.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
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Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 49 41 46 44 44 42 44 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
Clade A (92UG037.1) Number Analyzed 48 participants 41 participants 46 participants 44 participants 43 participants 42 participants 44 participants 46 participants
100.0
(92.6 to 100)
97.6
(87.14 to 99.94)
97.8
(88.47 to 99.94)
95.5
(84.53 to 99.44)
97.7
(87.71 to 99.94)
97.6
(87.43 to 99.94)
95.5
(84.53 to 99.44)
2.2
(0.06 to 11.53)
Clade B (1990a) Number Analyzed 48 participants 41 participants 46 participants 42 participants 42 participants 42 participants 44 participants 46 participants
100.0
(92.6 to 100)
100.0
(91.4 to 100)
100.0
(92.29 to 100)
100.0
(91.59 to 100)
100.0
(91.59 to 100)
100.0
(91.59 to 100)
100.0
(91.96 to 100)
6.5
(1.37 to 17.9)
Clade C (Con C) Number Analyzed 47 participants 41 participants 46 participants 44 participants 43 participants 42 participants 44 participants 46 participants
100.0
(92.45 to 100)
100.0
(91.4 to 100)
100.0
(92.29 to 100)
95.5
(84.53 to 99.44)
100.0
(91.78 to 100)
100.0
(91.59 to 100)
97.7
(87.98 to 99.94)
6.5
(1.37 to 17.9)
Clade C (C97ZA.012) Number Analyzed 48 participants 41 participants 46 participants 44 participants 43 participants 42 participants 44 participants 46 participants
100
(92.6 to 100)
100
(91.4 to 100)
100
(92.29 to 100)
97.7
(87.98 to 99.94)
100
(91.59 to 100)
100
(91.59 to 100)
100
(91.96 to 100)
2.2
(0.06 to 11.53)
6.Secondary Outcome
Title Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Gylcoprotein (gp) 140 Binding Antibody
Hide Description Vaccine-induced binding antibody IgG1, IgG2, IgG3 and IgG4 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQs for this assay were 12.3, 28.7, 12.4, and 13.2 for IgG1, IgG2, IgG3 and IgG4 respectively. Samples taken after Week 48 (W48) from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Time Frame Week 28, 52 and 96
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Hide Analysis Population Description
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 47 41 46 45 42 40 44 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
Clade C (C97ZA.012) IgG1 at Week 28 Number Analyzed 47 participants 41 participants 46 participants 45 participants 42 participants 40 participants 44 participants 45 participants
78.7
(64.34 to 89.3)
80.5
(65.13 to 91.18)
50.0
(34.9 to 65.1)
82.2
(67.95 to 92)
61.9
(45.64 to 76.43)
67.5
(50.87 to 81.43)
81.8
(67.29 to 91.81)
0.0
(0.0 to 7.87)
Clade C (C97ZA.012) IgG1 at Week 52 Number Analyzed 44 participants 38 participants 42 participants 41 participants 39 participants 40 participants 38 participants 40 participants
81.8
(67.29 to 91.81)
94.7
(82.25 to 99.36)
59.5
(43.28 to 74.37)
82.9
(67.94 to 92.85)
71.8
(55.13 to 85)
72.5
(56.11 to 85.4)
89.5
(75.2 to 97.06)
0
(0 to 8.81)
Clade C (C97ZA.012) IgG1 at Week 96 Number Analyzed 41 participants 38 participants 23 participants 21 participants 24 participants 25 participants 24 participants 0 participants
36.6
(22.12 to 53.06)
26.3
(13.4 to 43.1)
4.3
(0.11 to 21.95)
38.1
(18.11 to 61.56)
16.7
(4.74 to 37.38)
0
(0 to 13.72)
50.0
(29.12 to 70.88)
Clade C (C97ZA.012) IgG2 at Week 28 Number Analyzed 47 participants 41 participants 46 participants 45 participants 42 participants 40 participants 44 participants 45 participants
0
(0 to 7.55)
0
(0 to 8.6)
2.2
(0.06 to 11.53)
2.2
(0.06 to 11.77)
2.4
(0.06 to 12.57)
0
(0 to 8.81)
2.3
(0.06 to 12.02)
0
(0 to 7.87)
Clade C (C97ZA.012) IgG2 at Week 52 Number Analyzed 43 participants 38 participants 42 participants 41 participants 39 participants 40 participants 38 participants 40 participants
2.3
(0.06 to 12.29)
0
(0 to 9.25)
0
(0 to 8.41)
4.9
(0.6 to 16.53)
7.7
(1.62 to 20.87)
0
(0 to 8.81)
7.9
(1.66 to 21.38)
0
(0 to 8.81)
Clade C (C97ZA.012) IgG3 at Week 28 Number Analyzed 47 participants 41 participants 46 participants 44 participants 41 participants 39 participants 44 participants 45 participants
44.7
(30.17 to 59.88)
29.3
(16.13 to 45.54)
10.9
(3.62 to 23.57)
47.7
(32.46 to 63.31)
29.3
(16.13 to 45.54)
20.5
(9.3 to 36.46)
25.0
(13.19 to 40.34)
0
(0 to 7.87)
Clade C (C97ZA.012) IgG3 at Week 52 Number Analyzed 44 participants 38 participants 42 participants 41 participants 39 participants 39 participants 37 participants 40 participants
43.2
(28.35 to 58.97)
42.1
(26.31 to 59.18)
7.1
(1.5 to 19.48)
51.2
(35.13 to 67.12)
35.9
(21.2 to 52.82)
15.4
(5.86 to 30.53)
43.2
(27.1 to 60.51)
0
(0 to 8.81)
Clade C (C97ZA.012) IgG3 at Week 96 Number Analyzed 41 participants 36 participants 25 participants 22 participants 22 participants 24 participants 24 participants 0 participants
12.2
(4.08 to 26.2)
8.3
(1.75 to 22.47)
4.0
(0.1 to 20.35)
4.5
(0.12 to 22.84)
13.6
(2.91 to 34.91)
8.3
(1.03 to 27)
16.7
(4.74 to 37.38)
Clade C (C97ZA.012) IgG4 at Week 28 Number Analyzed 47 participants 41 participants 45 participants 45 participants 42 participants 40 participants 44 participants 45 participants
0
(0 to 7.55)
0
(0 to 8.6)
0
(0 to 7.87)
4.4
(0.54 to 15.15)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 8.04)
0
(0 to 7.87)
Clade C (C97ZA.012) IgG4 at Week 52 Number Analyzed 44 participants 38 participants 42 participants 41 participants 39 participants 40 participants 38 participants 40 participants
2.3
(0.06 to 12.02)
2.6
(0.07 to 13.81)
0
(0 to 8.41)
7.3
(1.54 to 19.92)
0
(0 to 9.03)
0
(0 to 8.81)
5.3
(0.64 to 17.75)
0
(0 to 8.81)
7.Secondary Outcome
Title Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens
Hide Description The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQ for this assay is a 50 percent (%) inhibitory concentration (IC50) of 20 (fold-dilution). The lower limits of quantification (LLOQs) for this assay were 625 and 78.125 EU/mL for Clade C (Con C) and Mos1 respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Time Frame Week 28, 52 and 96
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Hide Analysis Population Description
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 49 41 46 44 44 42 44 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
Consensus C (Con C) at Week 28 Number Analyzed 47 participants 41 participants 46 participants 44 participants 43 participants 42 participants 44 participants 46 participants
100
(92.45 to 100)
100.0
(91.4 to 100)
100.0
(92.29 to 100)
95.5
(84.53 to 99.44)
100.0
(91.78 to 100)
100.0
(91.59 to 100)
97.7
(87.98 to 99.94)
6.5
(1.37 to 17.9)
Consensus C (Con C) at Week 52 Number Analyzed 44 participants 40 participants 42 participants 41 participants 40 participants 42 participants 38 participants 42 participants
100.0
(92.13 to 100)
100.0
(91.19 to 100)
100.0
(91.59 to 100)
95.1
(83.47 to 99.4)
100.0
(91.19 to 100)
100.0
(91.59 to 100)
97.4
(86.19 to 99.93)
2.4
(0.06 to 12.57)
Mos1 at Week 28 Number Analyzed 46 participants 40 participants 46 participants 43 participants 43 participants 42 participants 44 participants 46 participants
100.0
(92.29 to 100)
100.0
(91.19 to 100)
100.0
(92.29 to 100)
97.7
(87.71 to 99.94)
100.0
(91.78 to 100)
100.0
(91.59 to 100)
97.7
(87.98 to 99.94)
4.3
(0.53 to 14.84)
Mos1 at Week 52 Number Analyzed 44 participants 40 participants 41 participants 40 participants 39 participants 42 participants 36 participants 42 participants
100.0
(91.96 to 100.0)
100.0
(91.19 to 100.0)
100.0
(91.4 to 100.0)
97.5
(86.84 to 99.94)
100.0
(90.97 to 100.0)
100.0
(91.59 to 100.0)
100.0
(90.26 to 100)
0
(0 to 8.41)
Mos1 at Week 96 Number Analyzed 42 participants 38 participants 42 participants 38 participants 39 participants 42 participants 35 participants 40 participants
100.0
(91.59 to 100.0)
100.0
(90.75 to 100.0)
100.0
(91.59 to 100.0)
97.4
(86.19 to 99.93)
100.0
(90.97 to 100.0)
100.0
(91.59 to 100)
97.1
(85.08 to 99.93)
0
(0 to 8.81)
8.Secondary Outcome
Title Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Hide Description The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value > limit of detection (LOD) if baseline <LOD or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012), and Mos1, respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category of Clade A, B, C and Mos 1.
Time Frame Week 16, 26, 28, 52, 78, and 96
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Hide Analysis Population Description
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 47 41 46 45 42 42 44 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
Clade A (92UG037.1) at Week 16 Number Analyzed 10 participants 10 participants 10 participants 9 participants 8 participants 6 participants 9 participants 8 participants
20.0
(2.52 to 55.61)
20.0
(2.52 to 55.61)
10.0
(0.25 to 44.5)
66.7
(29.93 to 92.51)
0
(0 to 36.94)
0
(0 to 45.93)
0
(0 to 33.63)
0
(0 to 36.94)
Clade A (92UG037.1) at Week 28 Number Analyzed 47 participants 41 participants 46 participants 45 participants 42 participants 42 participants 44 participants 46 participants
36.2
(22.67 to 51.48)
29.3
(16.13 to 45.54)
6.5
(1.37 to 17.9)
46.7
(31.66 to 62.13)
21.4
(10.3 to 36.81)
22.5
(10.84 to 38.45)
9.1
(2.53 to 21.67)
0
(0 to 7.71)
Clade B (1990a) at Week 16 Number Analyzed 10 participants 10 participants 10 participants 9 participants 8 participants 6 participants 9 participants 8 participants
50.0
(18.71 to 81.29)
50.0
(18.71 to 81.29)
30.0
(6.67 to 65.25)
66.7
(29.93 to 92.51)
37.5
(8.52 to 75.51)
16.7
(0.42 to 64.12)
33.3
(7.49 to 70.07)
0
(0 to 36.94)
Clade B (1990a) at Week 28 Number Analyzed 47 participants 41 participants 46 participants 45 participants 42 participants 42 participants 44 participants 46 participants
78.7
(64.34 to 89.3)
53.7
(37.42 to 69.34)
37.0
(23.21 to 52.45)
71.1
(55.69 to 83.63)
61.9
(45.64 to 76.43)
72.5
(56.11 to 85.4)
36.4
(2.41 to 52.23)
0
(0 to 7.71)
Clade C (Con C) at Week 16 Number Analyzed 10 participants 10 participants 10 participants 9 participants 8 participants 6 participants 9 participants 8 participants
30.0
(6.67 to 65.25)
30.0
(6.67 to 65.25)
0
(0 to 30.85)
55.6
(21.2 to 86.3)
37.5
(8.52 to 75.51)
0
(0 to 45.93)
11.1
(0.28 to 48.25)
0
(0 to 36.94)
Clade C (Con C) at Week 28 Number Analyzed 47 participants 41 participants 46 participants 45 participants 42 participants 42 participants 44 participants 46 participants
55.3
(40.12 to 69.83)
39.0
(24.2 to 55.5)
41.3
(27 to 56.77)
53.3
(37.87 to 68.34)
45.2
(29.85 to 61.33)
47.5
(31.51 to 63.87)
43.2
(28.35 to 58.97)
8.7
(2.42 to 20.79)
Clade C (C97ZA.012) at Week 16 Number Analyzed 10 participants 10 participants 10 participants 9 participants 8 participants 6 participants 9 participants 8 participants
20.0
(2.52 to 55.61)
40.0
(12.16 to 73.76)
30.0
(6.67 to 65.25)
44.4
(13.7 to 78.8)
12.5
(0.32 to 52.65)
0
(0 to 45.93)
11.1
(0.28 to 48.25)
0
(0 to 36.94)
Clade C (C97ZA.012) at Week 26 Number Analyzed 46 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
93.5
(82.1 to 98.63)
Clade C (C97ZA.012) at Week 28 Number Analyzed 47 participants 41 participants 46 participants 45 participants 42 participants 42 participants 44 participants 46 participants
72.3
(57.36 to 84.38)
53.7
(37.42 to 69.34)
19.6
(9.36 to 33.91)
57.8
(42.15 to 72.34)
50.0
(34.19 to 65.81)
37.5
(22.73 to 54.2)
45.5
(30.39 to 61.15)
0
(0 to 7.71)
Clade C (C97ZA.012) at Week 52 Number Analyzed 45 participants 39 participants 42 participants 41 participants 40 participants 42 participants 38 participants 41 participants
80.0
(65.4 to 90.42)
64.1
(47.18 to 78.8)
23.8
(12.05 to 39.45)
70.7
(54.46 to 83.87)
60.0
(43.33 to 75.14)
21.4
(10.3 to 36.81)
71.1
(54.1 to 84.58)
0
(0 to 8.6)
Clade C (C97ZA.012) at Week 78 Number Analyzed 44 participants 39 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
29.5
(16.76 to 45.2)
15.4
(5.86 to 30.53)
Clade C (C97ZA.012) at Week 96 Number Analyzed 42 participants 38 participants 25 participants 22 participants 24 participants 25 participants 24 participants 0 participants
9.5
(2.66 to 22.62)
10.5
(2.94 to 24.8)
0
(0 to 13.72)
18.2
(5.19 to 40.28)
4.2
(0.11 to 21.12)
0
(0 to 13.72)
12.5
(2.66 to 32.36)
Mos1 at Week 16 Number Analyzed 10 participants 10 participants 10 participants 9 participants 8 participants 6 participants 9 participants 8 participants
90.0
(55.5 to 99.75)
90.0
(55.5 to 99.75)
70.0
(34.75 to 93.33)
77.8
(39.99 to 97.19)
100.0
(63.06 to 100.0)
83.3
(35.88 to 99.58)
88.9
(51.75 to 99.72)
0
(0 to 36.94)
Mos1 at Week 28 Number Analyzed 47 participants 41 participants 46 participants 45 participants 42 participants 42 participants 44 participants 46 participants
95.7
(85.46 to 99.48)
87.8
(73.8 to 95.92)
84.8
(71.13 to 93.66)
93.3
(81.73 to 98.6)
92.9
(80.52 to 98.5)
92.5
(79.61 to 98.43)
86.4
(72.65 to 94.83)
0
(0 to 7.71)
9.Secondary Outcome
Title Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb)
Hide Description The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value >LLOQ. The LLOQ for this assay is an inhibitory concentration (IC50) of 20 (fold-dilution). Data reported for the responses against Tier 1 HIV strain Clade C (MW965.26) was reported. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Time Frame Week 28 and 52
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Hide Analysis Population Description
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 48 41 46 45 44 42 44 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
Clade C (MW965.26) Tier 1 at Week 28 Number Analyzed 48 participants 41 participants 46 participants 45 participants 44 participants 41 participants 44 participants 46 participants
54.2
(39.17 to 68.63)
41.5
(26.32 to 57.89)
21.7
(10.95 to 36.36)
51.1
(35.77 to 66.3)
43.2
(28.35 to 58.97)
36.6
(22.12 to 53.06)
29.5
(16.76 to 45.2)
2.2
(0.06 to 11.53)
Clade C (MW965.26) Tier 1 at Week 52 Number Analyzed 45 participants 38 participants 42 participants 41 participants 40 participants 42 participants 38 participants 41 participants
75.6
(60.46 to 87.12)
65.8
(48.65 to 80.37)
11.9
(3.98 to 25.63)
73.2
(57.06 to 85.78)
52.5
(36.13 to 68.49)
45.2
(29.85 to 61.33)
68.4
(51.35 to 82.5)
2.4
(0.06 to 12.86)
10.Secondary Outcome
Title Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Hide Description The human immunodeficiency virus (HIV)-1 BAMA employs flow-cytometric-based technology that also utilizes antibody and antigen interactions to test for the presence of specific antibodies in an unknown sample with the added advantage of multiplexing the antigens of interest. Positive and negative control standards were run with each assay to ensure specificity. The positivity threshold was determined per antigen based on the plus (+) 3 standard deviation (SD) on the non-specific background. Sample values had to be greater than or equal to this value and had to be 3-fold over the baseline values with a minimum median fluorescent intensities (MFI) value of 100. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Time Frame Week 16, 28, 52, 78, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
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Arm/Group Title Group 1: Ad26/Ad26 + gp140 High Dose (HD) Group 2: Ad26/Ad26 + gp140 Low Dose (LD) Group 3: Ad26/Ad26 Group 4: Ad26/MVA + gp140 HD Group 5: Ad26/ MVA + gp140 LD Group 6: Ad26/MVA Group 7: Ad26/ gp140 HD Group 8: Placebo/ Placebo
Hide Arm/Group Description:
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Overall Number of Participants Analyzed 48 40 46 44 44 44 43 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
HIV ENV Con S gp140 CFI(Clade M)IgG1 Ab Week(W)16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
76.6
(61.97 to 87.7)
HIV ENV Con S gp140 CFI (Clade M) IgG1 Ab at W28 Number Analyzed 48 participants 37 participants 46 participants 44 participants 41 participants 41 participants 43 participants 45 participants
95.8
(85.75 to 99.49)
94.6
(81.81 to 99.34)
76.1
(61.23 to 87.41)
90.9
(78.33 to 97.47)
97.6
(87.14 to 99.94)
95.1
(83.47 to 99.4)
88.4
(74.92 to 96.11)
0
(0 to 7.87)
HIV ENV Con S gp140 CFI (Clade M) IgG1 Ab at W52 Number Analyzed 45 participants 34 participants 42 participants 40 participants 37 participants 41 participants 36 participants 41 participants
95.6
(84.85 to 99.46)
97.1
(84.67 to 99.93)
61.9
(45.64 to 76.43)
92.5
(79.61 to 98.43)
100.0
(90.51 to 100.0)
80.5
(65.13 to 91.18)
94.4
(81.34 to 99.32)
0
(0 to 8.6)
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
14.9
(6.2 to 28.31)
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W28 Number Analyzed 48 participants 37 participants 46 participants 44 participants 41 participants 41 participants 43 participants 45 participants
60.4
(45.27 to 74.23)
40.5
(24.75 to 57.9)
15.2
(6.34 to 28.87)
59.1
(43.25 to 73.66)
39.0
(24.2 to 55.5)
39.0
(24.2 to 55.5)
23.3
(11.76 to 38.63)
0
(0 to 7.87)
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W52 Number Analyzed 45 participants 34 participants 42 participants 40 participants 37 participants 41 participants 36 participants 41 participants
60.0
(44.33 to 74.3)
44.1
(27.19 to 62.11)
11.9
(3.98 to 25.63)
62.5
(45.8 to 77.27)
35.1
(20.21 to 52.54)
19.5
(8.82 to 34.87)
22.2
(10.12 to 39.15)
0
(0 to 8.6)
HIV ENV gp41 IgG1 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
59.6
(44.27 to 73.63)
HIV ENV gp41 IgG1 Ab at W28 Number Analyzed 48 participants 37 participants 46 participants 44 participants 41 participants 41 participants 43 participants 45 participants
95.8
(85.75 to 99.49)
94.6
(81.81 to 99.34)
78.3
(63.64 to 89.05)
90.9
(78.33 to 97.47)
97.6
(87.14 to 99.94)
82.9
(67.94 to 92.85)
95.3
(84.19 to 99.43)
0
(0 to 7.87)
HIV ENV gp41 IgG1 Ab at W52 Number Analyzed 45 participants 34 participants 42 participants 40 participants 37 participants 41 participants 36 participants 41 participants
95.6
(84.85 to 99.46)
97.1
(84.67 to 99.93)
61.9
(45.64 to 76.43)
92.5
(79.61 to 98.43)
97.3
(85.84 to 99.93)
68.3
(51.91 to 81.92)
97.2
(85.47 to 99.93)
0
(0 to 8.6)
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
40.4
(26.37 to 55.73)
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W28 Number Analyzed 48 participants 37 participants 46 participants 44 participants 41 participants 41 participants 43 participants 45 participants
85.4
(72.24 to 93.93)
70.3
(53.02 to 84.13)
56.5
(41.11 to 71.07)
79.5
(64.7 to 90.2)
87.8
(73.8 to 95.92)
70.7
(54.46 to 83.87)
72.1
(56.33 to 84.67)
0
(0 to 7.87)
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W52 Number Analyzed 45 participants 34 participants 42 participants 40 participants 37 participants 41 participants 36 participants 41 participants
80.0
(65.4 to 90.42)
79.4
(62.1 to 91.3)
35.7
(21.55 to 51.97)
82.5
(67.22 to 92.66)
83.8
(67.99 to 93.81)
46.3
(30.66 to 62.58)
83.3
(67.19 to 93.63)
0
(0 to 8.6)
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
74.5
(59.65 to 86.06)
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W28 Number Analyzed 48 participants 37 participants 46 participants 44 participants 41 participants 41 participants 43 participants 45 participants
93.8
(82.8 to 98.69)
94.6
(81.81 to 99.34)
76.1
(61.23 to 87.41)
90.9
(78.33 to 97.47)
100.0
(91.4 to 100.0)
100.0
(91.4 to 100.0)
86.0
(72.07 to 94.7)
0
(0 to 7.87)
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W52 Number Analyzed 45 participants 34 participants 42 participants 40 participants 37 participants 41 participants 36 participants 41 participants
95.6
(84.85 to 99.46)
97.1
(84.67 to 99.93)
76.2
(60.55 to 87.95)
92.5
(79.61 to 98.43)
97.3
(85.84 to 99.93)
90.2
(76.87 to 97.28)
94.4
(81.34 to 99.32)
0
(0 to 8.6)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
6.4
(1.34 to 17.54)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W28 Number Analyzed 48 participants 37 participants 46 participants 44 participants 41 participants 41 participants 43 participants 45 participants
16.7
(7.48 to 30.22)
10.8
(3.03 to 25.42)
2.2
(0.06 to 11.53)
18.2
(8.19 to 32.71)
19.5
(8.82 to 34.87)
4.9
(0.6 to 16.53)
7.0
(1.46 to 19.06)
0
(0 to 7.87)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W52 Number Analyzed 45 participants 34 participants 42 participants 40 participants 37 participants 41 participants 36 participants 41 participants
20.0
(9.58 to 34.6)
8.8
(1.86 to 23.68)
4.8
(0.58 to 16.16)
25.0
(12.69 to 41.2)
13.5
(4.54 to 28.77)
9.8
(2.72 to 23.13)
13.9
(4.67 to 29.5)
0
(0 to 8.6)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
14.9
(6.2 to 28.31)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W28 Number Analyzed 48 participants 37 participants 46 participants 44 participants 41 participants 41 participants 43 participants 45 participants
29.2
(16.95 to 44.06)
27.0
(13.79 to 44.12)
10.9
(3.62 to 23.57)
20.5
(9.8 to 35.3)
22.0
(10.56 to 37.61)
7.3
(1.54 to 19.92)
7.0
(1.46 to 19.06)
0
(0 to 7.87)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W52 Number Analyzed 45 participants 34 participants 42 participants 40 participants 37 participants 41 participants 36 participants 41 participants
13.3
(5.05 to 26.79)
14.7
(4.95 to 31.06)
9.5
(2.66 to 22.62)
22.5
(10.84 to 38.45)
13.5
(4.54 to 28.77)
0
(0 to 8.6)
13.9
(4.67 to 29.5)
2.4
(0.06 to 12.86)
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
(0 to 7.4)
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 42 participants 40 participants 43 participants 45 participants
2.1
(0.05 to 11.07)
0
(0 to 8.81)
0
(0 to 7.71)
0
(0 to 8.22)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 8.22)
0
(0 to 7.87)
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 40 participants 37 participants 41 participants 37 participants 41 participants
2.2
(0.06 to 11.77)
0
(0 to 9.49)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 9.49)
0
(0 to 8.6)
0
(0 to 9.49)
0
(0 to 8.6)
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
(0 to 7.4)
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 42 participants 40 participants 43 participants 45 participants
0
(0 to 7.4)
0
(0 to 8.81)
0
(0 to 7.71)
0
(0 to 8.22)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 8.22)
0
(0 to 7.87)
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 40 participants 37 participants 41 participants 37 participants 41 participants
0
(0 to 7.87)
0
(0 to 9.49)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 9.49)
0
(0 to 8.6)
0
(0 to 9.49)
0
(0 to 8.6)
HIV ENV gp41 IgG2 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
(0 to 7.4)
HIV ENV gp41 IgG2 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 42 participants 40 participants 43 participants 45 participants
2.1
(0.05 to 11.07)
0
(0 to 8.81)
0
(0 to 7.71)
2.3
(0.06 to 12.29)
2.4
(0.06 to 12.57)
0
(0 to 8.81)
0
(0 to 8.22)
0
(0 to 7.87)
HIV ENV gp41 IgG2 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 40 participants 37 participants 41 participants 37 participants 41 participants
0
(0 to 7.87)
2.7
(0.07 to 14.16)
0
(0 to 8.41)
5.0
(0.61 to 16.92)
0
(0 to 9.49)
0
(0 to 8.6)
0
(0 to 9.49)
0
(0 to 8.6)
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
2.1
(0.05 to 11.07)
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 42 participants 40 participants 43 participants 45 participants
2.1
(0.05 to 11.07)
0
(0 to 8.81)
0
(0 to 7.71)
2.3
(0.06 to 12.29)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 8.22)
0
(0 to 7.87)
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 40 participants 37 participants 41 participants 37 participants 41 participants
0
(0 to 7.87)
0
(0 to 9.49)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 9.49)
0
(0 to 8.6)
0
(0 to 9.49)
0
(0 to 8.6)
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
2.1
(0.05 to 11.07)
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 42 participants 40 participants 41 participants 45 participants
2.1
(0.05 to 11.07)
0
(0 to 8.81)
0
(0 to 7.71)
2.3
(0.06 to 12.29)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 8.22)
0
(0 to 7.87)
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 40 participants 37 participants 41 participants 37 participants 41 participants
2.2
(0.06 to 11.77)
0
(0 to 9.49)
0
(0 to 8.41)
2.5
(0.06 to 13.16)
2.7
(0.07 to 14.16)
0
(0 to 8.6)
0
(0 to 9.49)
0
(0 to 8.6)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
(0 to 7.4)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 42 participants 40 participants 43 participants 45 participants
0
(0 to 7.4)
0
(0 to 8.81)
0
(0 to 7.71)
0
(0 to 8.22)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 8.22)
0
(0 to 7.87)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 40 participants 37 participants 41 participants 37 participants 41 participants
0
(0 to 7.87)
0
(0 to 9.49)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 9.49)
0
(0 to 8.6)
0
(0 to 9.49)
0
(0 to 8.6)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
(0 to 7.4)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 42 participants 40 participants 43 participants 45 participants
0
(0 to 7.4)
2.5
(0.06 to 13.16)
0
(0 to 7.71)
0
(0 to 8.22)
2.4
(0.06 to 12.57)
0
(0 to 8.81)
0
(0 to 8.22)
0
(0 to 7.87)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 40 participants 37 participants 41 participants 37 participants 41 participants
0
(0 to 7.87)
0
(0 to 9.49)
0
(0 to 8.41)
0
(0 to 8.81)
0
(0 to 9.49)
0
(0 to 8.6)
0
(0 to 9.49)
0
(0 to 8.6)
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
61.7
(46.38 to 75.49)
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 43 participants 41 participants 43 participants 45 participants
75.0
(60.4 to 86.36)
47.5
(31.51 to 63.87)
34.8
(21.35 to 50.25)
76.7
(61.37 to 88.24)
79.1
(63.96 to 89.96)
58.5
(42.11 to 73.68)
67.4
(51.46 to 80.92)
0
(0 to 7.87)
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W52 Number Analyzed 43 participants 37 participants 41 participants 38 participants 39 participants 41 participants 37 participants 39 participants
76.7
(61.37 to 88.24)
59.5
(42.1 to 75.25)
56.1
(39.75 to 71.53)
78.9
(62.68 to 90.45)
82.1
(66.47 to 92.46)
48.8
(32.88 to 64.87)
81.1
(64.84 to 92.04)
7.7
(1.62 to 20.87)
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W78 Number Analyzed 43 participants 38 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
53.5
(37.65 to 68.82)
28.9
(15.42 to 45.9)
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W96 Number Analyzed 41 participants 35 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
48.8
(32.88 to 64.87)
34.3
(19.13 to 52.21)
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
31.9
(19.09 to 47.12)
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 43 participants 41 participants 43 participants 45 participants
31.3
(18.66 to 46.25)
22.5
(10.84 to 38.45)
10.9
(3.62 to 23.57)
32.6
(19.08 to 48.54)
23.3
(11.76 to 38.63)
22.0
(10.56 to 37.61)
11.6
(3.89 to 25.08)
0
(0 to 7.87)
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W52 Number Analyzed 43 participants 37 participants 41 participants 38 participants 39 participants 41 participants 37 participants 39 participants
48.8
(33.31 to 64.54)
27.0
(13.79 to 44.12)
17.1
(7.15 to 32.06)
47.4
(30.98 to 64.18)
46.2
(30.09 to 62.82)
31.7
(18.08 to 48.09)
24.3
(11.77 to 41.2)
2.6
(0.06 to 13.48)
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W78 Number Analyzed 43 participants 38 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
14.0
(5.3 to 27.93)
7.9
(1.66 to 21.38)
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W96 Number Analyzed 41 participants 35 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
17.1
(7.15 to 32.06)
8.6
(1.8 to 23.06)
HIV ENV gp41 IgG3 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
25.5
(13.94 to 40.35)
HIV ENV gp41 IgG3 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 43 participants 41 participants 43 participants 45 participants
52.1
(37.19 to 66.71)
45.0
(29.26 to 61.51)
13.0
(4.94 to 26.26)
55.8
(39.88 to 70.92)
58.1
(42.13 to 72.99)
26.8
(14.22 to 42.94)
46.5
(31.18 to 62.35)
0
(0 to 7.87)
43HIV ENV gp41 IgG3 Ab at W52 Number Analyzed 43 participants 37 participants 41 participants 38 participants 39 participants 41 participants 41 participants 39 participants
67.4
(51.46 to 80.92)
54.1
(36.92 to 70.51)
14.6
(5.57 to 29.17)
73.7
(56.9 to 86.6)
79.5
(63.54 to 90.7)
26.8
(14.22 to 42.94)
67.6
(50.21 to 81.99)
7.7
(1.62 to 20.87)
HIV ENV gp41 IgG3 Ab at W78 Number Analyzed 43 participants 38 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
34.9
(21.01 to 50.93)
23.7
(11.44 to 40.24)
HIV ENV gp41 IgG3 Ab at W96 Number Analyzed 41 participants 35 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
31.7
(18.08 to 48.09)
22.9
(10.42 to 40.14)
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
68.1
(52.88 to 80.91)
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 43 participants 41 participants 43 participants 45 participants
66.7
(51.59 to 79.6)
50.0
(33.8 to 66.2)
39.1
(25.09 to 54.63)
65.1
(49.07 to 78.99)
65.1
(49.07 to 78.99)
58.5
(42.11 to 73.68)
53.5
(37.65 to 68.82)
0
(0 to 7.87)
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W52 Number Analyzed 43 participants 37 participants 41 participants 38 participants 39 participants 41 participants 37 participants 39 participants
76.7
(61.37 to 88.24)
67.6
(50.21 to 81.99)
51.2
(35.13 to 67.12)
78.9
(62.68 to 90.45)
82.1
(66.47 to 92.46)
58.5
(42.11 to 73.68)
75.7
(58.8 to 88.23)
2.6
(0.06 to 13.48)
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W78 Number Analyzed 43 participants 38 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
53.5
(37.65 to 68.82)
39.5
(24.04 to 56.61)
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W96 Number Analyzed 41 participants 35 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
48.8
(32.88 to 64.87)
37.1
(21.47 to 55.08)
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
74.5
(59.65 to 86.06)
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 43 participants 41 participants 43 participants 45 participants
83.3
(69.78 to 92.52)
60.0
(43.33 to 75.14)
67.4
(51.98 to 80.47)
86.0
(72.07 to 94.7)
86.0
(72.07 to 94.7)
75.6
(59.7 to 87.64)
76.7
(61.37 to 88.24)
0
(0 to 7.87)
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W52 Number Analyzed 43 participants 37 participants 41 participants 38 participants 39 participants 41 participants 37 participants 39 participants
81.4
(66.6 to 91.61)
70.3
(53.02 to 84.13)
65.9
(49.41 to 79.92)
86.8
(71.91 to 95.59)
87.2
(72.57 to 95.7)
61.0
(44.5 to 75.8)
83.8
(67.99 to 93.81)
2.6
(0.06 to 13.48)
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W78 Number Analyzed 43 participants 38 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
55.8
(39.88 to 70.92)
36.8
(21.81 to 54.01)
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W96 Number Analyzed 41 participants 35 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
46.3
(30.66 to 62.58)
31.4
(16.85 to 49.29)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
12.8
(4.83 to 25.74)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 43 participants 41 participants 43 participants 45 participants
18.8
(8.95 to 32.63)
12.5
(4.19 to 26.8)
6.5
(1.37 to 17.9)
23.3
(11.76 to 38.63)
16.3
(6.81 to 30.7)
14.6
(5.57 to 29.17)
16.3
(6.81 to 30.7)
0
(0 to 7.87)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W52 Number Analyzed 43 participants 37 participants 41 participants 38 participants 39 participants 41 participants 37 participants 39 participants
25.6
(13.52 to 41.17)
10.8
(3.03 to 25.42)
9.8
(2.72 to 23.13)
28.9
(15.42 to 45.9)
15.4
(5.86 to 30.53)
9.8
(2.72 to 23.13)
16.2
(6.19 to 32.01)
2.6
(0.06 to 13.48)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W78 Number Analyzed 43 participants 38 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
4.7
(0.57 to 15.81)
2.6
(0.07 to 13.81)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W96 Number Analyzed 41 participants 35 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
9.8
(2.72 to 23.13)
8.6
(1.8 to 23.06)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W16 Number Analyzed 47 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
14.9
(6.2 to 28.31)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W28 Number Analyzed 48 participants 40 participants 45 participants 43 participants 43 participants 41 participants 43 participants 45 participants
12.5
(4.73 to 25.25)
12.5
(4.19 to 26.8)
11.1
(3.71 to 24.05)
18.6
(8.39 to 33.4)
11.6
(3.89 to 25.08)
12.2
(4.08 to 26.2)
7.0
(1.46 to 19.06)
0
(0 to 7.87)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W52 Number Analyzed 43 participants 37 participants 40 participants 38 participants 39 participants 40 participants 37 participants 39 participants
18.6
(8.39 to 33.4)
10.8
(3.03 to 25.42)
5.0
(0.61 to 16.92)
28.9
(15.42 to 45.9)
7.7
(1.62 to 20.87)
7.5
(1.57 to 20.39)
10.8
(3.03 to 25.42)
2.6
(0.06 to 13.48)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W78 Number Analyzed 43 participants 38 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
2.3
(0.06 to 12.29)
2.6
(0.07 to 13.81)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W96 Number Analyzed 41 participants 35 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
2.4
(0.06 to 12.86)
2.9
(0.07 to 14.92)
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
10.4
(3.47 to 22.66)
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 44 participants 41 participants 43 participants 45 participants
12.5
(4.73 to 25.25)
10.0
(2.79 to 23.66)
13.0
(4.94 to 26.26)
9.3
(2.59 to 22.14)
9.1
(2.53 to 21.67)
7.3
(1.54 to 19.92)
16.3
(6.81 to 30.7)
0
(0 to 7.87)
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 38 participants 40 participants 41 participants 37 participants 41 participants
40.0
(25.7 to 55.67)
29.7
(15.87 to 46.98)
19.0
(8.6 to 34.12)
28.9
(15.42 to 45.9)
20.0
(9.05 to 35.65)
12.2
(4.08 to 26.2)
35.1
(20.21 to 52.54)
0
(0 to 8.6)
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
(0 to 7.4)
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 44 participants 41 participants 43 participants 45 participants
2.1
(0.05 to 11.07)
2.5
(0.06 to 13.16)
0
(0 to 7.71)
4.7
(0.57 to 15.81)
0
(0 to 8.04)
0
(0 to 8.6)
7.0
(1.46 to 19.06)
0
(0 to 7.87)
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 38 participants 40 participants 41 participants 37 participants 41 participants
15.6
(6.49 to 29.46)
10.8
(3.03 to 25.42)
2.4
(0.06 to 12.57)
18.4
(7.74 to 34.33)
5.0
(0.61 to 16.92)
0
(0 to 8.6)
8.1
(1.7 to 21.91)
0
(0 to 8.6)
HIV ENV gp41 IgG4 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
10.4
(3.47 to 22.66)
HIV ENV gp41 IgG4 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 44 participants 41 participants 43 participants 45 participants
33.3
(20.4 to 48.41)
15.0
(5.71 to 29.84)
13.0
(4.94 to 26.26)
25.6
(13.52 to 41.17)
20.5
(9.8 to 35.3)
7.3
(1.54 to 19.92)
34.9
(21.01 to 50.93)
2.2
(0.06 to 11.77)
HIV ENV gp41 IgG4 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 38 participants 40 participants 41 participants 37 participants 41 participants
66.7
(51.05 to 80)
56.8
(39.49 to 72.9)
16.7
(6.97 to 31.36)
52.6
(35.82 to 69.02)
45.0
(29.26 to 61.51)
7.3
(1.54 to 19.92)
62.2
(44.76 to 77.54)
7.3
(1.54 to 19.92)
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
10.4
(3.47 to 22.66)
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 44 participants 44 participants 43 participants 45 participants
14.6
(6.07 to 27.76)
7.5
(1.57 to 20.39)
6.5
(1.37 to 17.9)
9.3
(2.59 to 22.14)
6.8
(1.43 to 18.66)
9.8
(2.72 to 23.13)
14.0
(5.3 to 27.93)
0
(0 to 7.87)
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 38 participants 40 participants 41 participants 37 participants 41 participants
31.1
(18.17 to 46.65)
21.6
(9.83 to 38.21)
9.5
(2.66 to 22.62)
28.9
(15.42 to 45.9)
20.0
(9.05 to 35.65)
12.2
(4.08 to 26.2)
27.0
(13.79 to 44.12)
0
(0 to 8.6)
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
12.5
(4.73 to 25.25)
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 44 participants 41 participants 43 participants 45 participants
18.8
(8.95 to 32.63)
12.5
(4.19 to 26.8)
10.9
(3.62 to 23.57)
9.3
(2.59 to 22.14)
13.6
(5.17 to 27.35)
9.8
(2.72 to 23.13)
16.3
(6.81 to 30.7)
0
(0 to 7.87)
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 38 participants 40 participants 41 participants 37 participants 41 participants
46.7
(31.66 to 62.13)
35.1
(20.21 to 52.54)
16.7
(6.97 to 31.36)
28.9
(15.42 to 45.9)
40.0
(24.86 to 56.67)
22.0
(10.56 to 37.61)
37.8
(22.46 to 55.24)
0
(0 to 8.6)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
(0 to 7.4)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 44 participants 41 participants 43 participants 45 participants
2.1
(0.05 to 11.07)
2.5
(0.06 to 13.16)
0
(0 to 7.71)
4.7
(0.57 to 15.81)
2.3
(0.06 to 12.02)
2.4
(0.06 to 12.86)
2.3
(0.06 to 12.29)
0
(0 to 7.87)
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 38 participants 40 participants 41 participants 37 participants 41 participants
2.2
(0.06 to 11.77)
5.4
(0.66 to 18.19)
4.8
(0.58 to 16.16)
2.6
(0.07 to 13.81)
2.5
(0.06 to 13.16)
2.4
(0.06 to 12.86)
5.4
(0.66 to 18.19)
0
(0 to 8.6)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W16 Number Analyzed 48 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
(0 to 7.4)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W28 Number Analyzed 48 participants 40 participants 46 participants 43 participants 44 participants 41 participants 43 participants 45 participants
0
(0 to 7.4)
0
(0 to 8.81)
0
(0 to 7.71)
2.3
(0.06 to 12.29)
0
(0 to 8.04)
0
(0 to 8.6)
0
(0 to 8.22)
0
(0 to 7.87)
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W52 Number Analyzed 45 participants 37 participants 42 participants 38 participants 40 participants 41 participants 37 participants 41 participants
0
(0 to 7.87)
2.7
(0.07 to 14.16)
0
(0 to 8.41)
5.3
(0.64 to 17.75)
2.5
(0.06 to 13.16)
2.4
(0.06 to 12.86)
2.7
(0.07 to 14.16)
0
(0 to 8.6)
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W16 Number Analyzed 40 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
60.0
(43.33 to 75.14)
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W28 Number Analyzed 39 participants 31 participants 36 participants 35 participants 34 participants 38 participants 37 participants 38 participants
76.9
(60.67 to 88.87)
87.1
(70.17 to 96.37)
77.8
(60.85 to 89.88)
82.9
(66.35 to 93.44)
85.3
(68.94 to 95.05)
78.9
(62.68 to 90.45)
83.8
(67.99 to 93.81)
0
(0 to 9.25)
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W52 Number Analyzed 35 participants 25 participants 31 participants 26 participants 26 participants 32 participants 29 participants 32 participants
77.1
(59.86 to 89.58)
92.0
(73.97 to 99.02)
61.3
(42.19 to 78.15)
84.6
(65.13 to 95.64)
69.2
(48.21 to 85.67)
68.8
(49.99 to 83.88)
86.2
(68.34 to 96.11)
0
(0 to 10.89)
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W16 Number Analyzed 40 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
52.5
(36.13 to 68.49)
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W28 Number Analyzed 39 participants 31 participants 36 participants 35 participants 34 participants 38 participants 37 participants 38 participants
59.0
(42.1 to 74.43)
45.2
(27.32 to 63.97)
44.4
(27.94 to 61.9)
45.7
(28.83 to 63.35)
47.1
(29.78 to 64.87)
39.5
(24.04 to 56.61)
48.6
(31.92 to 65.6)
0
(0 to 9.25)
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W52 Number Analyzed 35 participants 25 participants 31 participants 26 participants 26 participants 32 participants 29 participants 32 participants
60.0
(42.11 to 76.13)
40.0
(21.13 to 61.33)
45.2
(27.32 to 63.97)
50.0
(29.93 to 70.07)
42.3
(23.35 to 63.08)
43.8
(26.36 to 62.34)
55.2
(35.69 to 73.55)
0
(0 to 10.89)
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W16 Number Analyzed 40 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
67.5
(50.87 to 81.43)
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W28 Number Analyzed 39 participants 31 participants 36 participants 35 participants 34 participants 38 participants 37 participants 38 participants
71.8
(55.13 to 85)
77.4
(58.9 to 90.41)
61.1
(43.46 to 76.86)
74.3
(56.74 to 87.51)
79.4
(62.1 to 91.3)
68.4
(51.35 to 82.5)
78.4
(61.79 to 90.17)
0
(0 to 9.25)
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W52 Number Analyzed 35 participants 25 participants 31 participants 26 participants 26 participants 32 participants 29 participants 31 participants
74.3
(56.74 to 87.51)
68.0
(46.5 to 85.05)
41.9
(24.55 to 60.92)
76.9
(56.35 to 91.03)
73.1
(52.21 to 88.43)
59.4
(40.64 to 76.3)
65.5
(45.67 to 82.06)
0
(0 to 11.22)
HIV ENV ConA1 gp140 (Clade A) IgA Ab at W16 Number Analyzed 40 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
30.0
(16.56 to 46.53)
HIV ENV ConA1 gp140 (Clade A) IgA Ab at W28 Number Analyzed 39 participants 31 participants 36 participants 35 participants 34 participants 38 participants 37 participants 38 participants
46.2
(30.09 to 62.82)
51.6
(33.06 to 69.85)
41.7
(25.51 to 59.24)
59.24
(31.38 to 66.01)
47.1
(29.78 to 64.87)
36.8
(21.81 to 54.01)
62.2
(44.76 to 77.54)
0
(0 to 9.25)
HIV ENV 00MSA gp140 (Clade A) IgA Ab at W16 Number Analyzed 40 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
45.0
(29.26 to 61.51)
HIV ENV 00MSA gp140 (Clade A) IgA Ab at W28 Number Analyzed 39 participants 31 participants 36 participants 35 participants 34 participants 38 participants 37 participants 38 participants
56.4
(39.62 to 72.19)
64.5
(45.37 to 80.77)
41.7
(25.51 to 59.24)
51.4
(33.99 to 68.62)
52.9
(35.13 to 70.22)
47.4
(30.98 to 64.18)
48.6
(31.92 to 65.6)
0
(0 to 9.25)
HIV ENV gp41 IgA Ab at W16 Number Analyzed 40 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
10.0
(2.79 to 23.66)
HIV ENV gp41 IgA Ab at W28 Number Analyzed 39 participants 31 participants 36 participants 35 participants 34 participants 38 participants 37 participants 38 participants
48.7
(32.42 to 65.22)
29.0
(14.22 to 48.04)
11.1
(3.11 to 26.06)
42.9
(26.32 to 60.65)
32.4
(17.39 to 50.53)
7.9
(1.66 to 21.38)
37.8
(22.46 to 55.24)
2.6
(0.07 to 13.81)
HIV ENV gp41 IgA Ab at W52 Number Analyzed 35 participants 25 participants 31 participants 26 participants 26 participants 32 participants 29 participants 32 participants
48.6
(31.38 to 66.01)
36.0
(17.97 to 57.48)
9.7
(2.04 to 25.75)
53.8
(33.37 to 73.41)
46.2
(26.59 to 66.63)
12.5
(3.51 to 28.99)
58.6
(38.94 to 76.48)
0
(0 to 10.89)
Clade A (51802) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
72.7
(57.21 to 85.04)
Clade A (51802) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
91.3
(79.21 to 97.58)
94.3
(80.84 to 99.3)
88.4
(74.92 to 96.11)
87.5
(73.2 to 95.81)
85.7
(69.74 to 95.19)
94.7
(82.25 to 99.36)
85.7
(71.46 to 94.57)
0
(0 to 8.81)
Clade A (51802) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
87.2
(72.57 to 95.7)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
86.8
(71.91 to 95.59)
90.9
(75.67 to 98.08)
5.6
(0.68 to 18.66)
Clade A (51802) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
79.5
(63.54 to 90.7)
81.8
(64.54 to 93.02)
Clade A (51802) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
68.4
(51.35 to 82.5)
74.2
(55.39 to 88.14)
Clade AE (254008) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
84.1
(69.93 to 93.36)
Clade AE (254008) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
89.1
(76.43 to 96.38)
97.1
(85.08 to 99.93)
88.4
(74.92 to 96.11)
85.0
(70.16 to 94.29)
85.7
(69.74 to 95.19)
97.4
(86.19 to 99.93)
88.1
(74.37 to 96.02)
0
(0 to 8.81)
Clade AE (254008) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
87.2
(72.57 to 95.7)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
92.1
(78.62 to 98.34)
93.9
(79.77 to 99.26)
0
(0 to 9.74)
Clade AE (254008) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
97.4
(86.52 to 99.94)
97.0
(84.24 to 99.92)
Clade AE (254008) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
94.7
(82.25 to 99.36)
90.3
(74.25 to 97.96)
Clade AE (A244) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
75.0
(59.66 to 86.81)
Clade AE (A244) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
91.3
(79.21 to 97.58)
91.4
(76.94 to 98.2)
81.4
(66.6 to 91.61)
90.0
(76.34 to 97.21)
85.7
(69.74 to 95.19)
94.7
(82.25 to 99.36)
88.1
(74.37 to 96.02)
0
(0 to 8.81)
Clade AE (A244) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
89.7
(75.78 to 97.13)
91.2
(76.32 to 98.14)
97.0
(84.24 to 99.92)
89.5
(75.2 to 97.06)
90.9
(75.67 to 98.08)
0
(0 to 9.74)
Clade AE (A244) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
84.6
(69.47 to 94.14)
84.8
(68.1 to 94.89)
Clade AE (A244) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
71.1
(54.1 to 84.58)
71.0
(51.96 to 85.78)
Clade B (B.6240) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
86.4
(72.65 to 94.83)
Clade B (B.6240) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
95.7
(85.16 to 99.47)
97.1
(85.08 to 99.93)
97.7
(87.71 to 99.94)
92.5
(79.61 to 98.43)
85.7
(69.74 to 95.19)
97.4
(86.19 to 99.93)
90.5
(77.38 to 97.34)
0
(0 to 8.81)
Clade B (B.6240) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 43 participants 45 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
92.3
(79.13 to 98.38)
94.1
(80.32 to 99.28)
100.0
(89.42 to 100.0)
97.4
(86.19 to 99.93)
93.9
(79.77 to 99.26)
0
(0 to 9.74)
Clade B (B.6240) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
84.6
(69.47 to 94.14)
93.9
(79.77 to 99.26)
Clade B (B.6240) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
86.8
(71.91 to 95.59)
93.5
(78.58 to 99.21)
Clade B (BORI) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
95.5
(84.53 to 99.44)
Clade B (BORI) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
95.7
(85.16 to 99.47)
97.1
(85.08 to 99.93)
93.0
(80.94 to 98.54)
90.0
(76.34 to 97.21)
88.6
(73.26 to 96.8)
97.4
(86.19 to 99.93)
90.5
(77.38 to 97.34)
0
(0 to 8.81)
Clade B (BORI) IgG-t Ab at Week 52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
97.4
(86.52 to 99.94)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
97.4
(86.19 to 99.93)
93.9
(79.77 to 99.26)
0
(0 to 9.74)
Clade B (BORI) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
84.6
(69.47 to 94.14)
84.8
(68.1 to 94.89)
Clade B (BORI) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
73.7
(56.9 to 86.6)
74.2
(55.39 to 88.14)
Clade B (TT31P) gp120 IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
90.9
(78.33 to 97.47)
Clade B (TT31P) gp120 IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
95.7
(85.16 to 99.47)
91.4
(76.94 to 98.2)
90.7
(77.86 to 97.41)
92.5
(79.61 to 98.43)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
88.1
(74.37 to 96.02)
0
(0 to 8.81)
Clade B (TT31P) gp120 IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
94.9
(82.68 to 99.37)
94.1
(80.32 to 99.28)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
90.9
(75.67 to 98.08)
0
(0 to 9.74)
Clade B (TT31P) gp120 IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
87.2
(72.57 to 95.7)
93.9
(79.77 to 99.26)
Clade B (TT31P) gp120 IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
86.8
(71.91 to 95.59)
87.1
(70.17 to 96.37)
Clade BC (CNE20) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
90.9
(78.33 to 97.47)
Clade BC (CNE20) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
93.5
(82.1 to 98.63)
94.3
(80.84 to 99.3)
90.7
(77.86 to 97.41)
90.0
(76.34 to 97.21)
88.6
(73.26 to 96.8)
97.4
(86.19 to 99.93)
92.9
(80.52 to 98.5)
0
(0 to 8.81)
Clade BC (CNE20) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
97.4
(86.52 to 99.94)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
94.7
(82.25 to 99.36)
93.9
(79.77 to 99.26)
0
(0 to 9.74)
Clade BC (CNE20) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
84.6
(69.47 to 94.14)
93.9
(79.77 to 99.26)
Clade BC (CNE20) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
78.9
(62.68 to 90.45)
87.1
(70.17 to 96.37)
Clade BC(BJOX002) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
75.0
(59.66 to 86.81)
Clade BC(BJOX002) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
87.0
(73.74 to 95.06)
94.3
(80.84 to 99.3)
88.4
(74.92 to 96.11)
85.0
(70.16 to 94.29)
82.9
(66.35 to 93.44)
89.5
(75.2 to 97.06)
90.5
(77.38 to 97.34)
0
(0 to 8.81)
Clade BC(BJOX002) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
89.7
(75.78 to 97.13)
97.1
(84.67 to 99.93)
97.0
(84.24 to 99.92)
94.7
(82.25 to 99.36)
93.9
(79.77 to 99.26)
0
(0 to 9.74)
Clade BC(BJOX002) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
74.4
(57.87 to 86.96)
75.8
(57.74 to 88.91)
Clade BC(BJOX002) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
68.4
(51.35 to 82.5)
74.2
(55.39 to 88.14)
Clade C(1086C_D7) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
97.7
(87.98 to 99.94)
Clade C(1086C_D7) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
100.0
(92.29 to 100.0)
97.1
(85.08 to 99.93)
100.0
(91.78 to 100.0)
97.5
(86.84 to 99.94)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
90.75
(83.84 to 99.42)
0
(0 to 8.81)
Clade C(1086C_D7) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
100.0
(90.97 to 100.0)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
97.0
(84.24 to 99.92)
0
(0 to 9.74)
Clade C(1086C_D7) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
100.0
(90.97 to 100.0)
100.0
(89.42 to 100.0)
Clade C(1086C_D7) IgG-t Ab at Week 96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
97.4
(86.19 to 99.93)
96.8
(83.3 to 99.92)
B Clade M (Con 6) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
97.7
(87.98 to 99.94)
B Clade M (Con 6) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
97.8
(88.47 to 99.94)
97.1
(85.08 to 99.93)
97.7
(87.71 to 99.94)
92.5
(79.61 to 98.43)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
92.9
(80.52 to 98.5)
0
(0 to 8.81)
B Clade M (Con 6) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
97.4
(86.52 to 99.94)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
97.0
(84.24 to 99.92)
0
(0 to 9.74)
B Clade M (Con 6) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
97.4
(86.52 to 99.94)
97.0
(84.24 to 99.92)
B Clade M (Con 6) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.1
(78.62 to 98.34)
93.5
(78.58 to 99.21)
Clade B (SC42261) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
95.5
(84.53 to 99.44)
Clade B (SC42261) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
97.8
(88.47 to 99.94)
97.1
(85.08 to 99.93)
100.0
(91.78 to 100.0)
95.0
(83.08 to 99.39)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
95.2
(83.84 to 99.42)
0
(0 to 8.81)
Clade B (SC42261) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
100.0
(90.97 to 100.0)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
97.0
(84.24 to 99.92)
0
(0 to 9.74)
Clade B (SC42261) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.3
(79.13 to 98.38)
97.0
(84.24 to 99.92)
Clade B (SC42261) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.1
(78.62 to 98.34)
93.5
(78.58 to 99.21)
Clade C (CH505TF) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
88.6
(75.44 to 96.21)
Clade C (CH505TF) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
93.5
(82.1 to 98.63)
97.1
(85.08 to 99.93)
93.0
(80.94 to 98.54)
92.5
(79.61 to 98.43)
85.7
(69.74 to 95.19)
97.4
(86.19 to 99.93)
95.2
(83.84 to 99.42)
0
(0 to 8.81)
Clade C (CH505TF) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
92.3
(79.13 to 98.38)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
97.0
(84.24 to 99.92)
0
(0 to 9.74)
Clade C (CH505TF) IgG-t Ab at W78 Number Analyzed 38 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
84.2
(68.75 to 93.98)
90.9
(75.67 to 98.08)
Clade C (CH505TF) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
81.6
(65.67 to 92.26)
77.4
(58.9 to 90.41)
C Clade A (9004S) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
84.1
(69.93 to 93.36)
C Clade A (9004S) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
91.3
(79.21 to 97.58)
94.3
(80.84 to 99.3)
90.7
(77.86 to 97.41)
90.0
(76.34 to 97.21)
85.7
(69.74 to 95.19)
97.4
(86.19 to 99.93)
88.1
(74.37 to 96.02)
0
(0 to 8.81)
C Clade A (9004S) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
94.9
(82.68 to 99.37)
100.0
(89.72 to 100.0)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
93.9
(79.77 to 99.26)
0
(0 to 9.74)
C Clade A (9004S) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
87.2
(72.57 to 95.7)
84.8
(68.1 to 94.89)
C Clade A (9004S) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
86.8
(71.91 to 95.59)
87.1
(70.17 to 96.37)
C Clade B (RHPA) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
97.7
(87.98 to 99.94)
C Clade B (RHPA) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
97.8
(88.47 to 99.94)
97.1
(85.08 to 99.93)
100.0
(91.78 to 100.0)
92.5
(79.61 to 98.43)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
95.2
(83.84 to 99.42)
0
(0 to 8.81)
C Clade B (RHPA) IgG-t Ab at Week 52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
100.0
(90.97 to 100.0)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
97.0
(84.24 to 99.92)
2.8
(0.07 to 14.53)
C Clade B (RHPA) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.3
(79.13 to 98.38)
97.0
(84.24 to 99.92)
C Clade B (RHPA) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.1
(78.62 to 98.34)
93.5
(78.58 to 99.21)
C Clade B (WITO) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
93.2
(81.34 to 98.57)
C Clade B (WITO) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
97.8
(88.47 to 99.94)
97.1
(85.08 to 99.93)
97.7
(87.71 to 99.94)
92.5
(79.61 to 98.43)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
95.2
(83.84 to 99.42)
0
(0 to 8.81)
C Clade B (WITO) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
97.4
(86.52 to 99.94)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
97.0
(84.24 to 99.92)
0
(0 to 9.74)
C Clade B (WITO) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
87.2
(72.57 to 95.7)
97.0
(84.24 to 99.92)
C Clade B (WITO) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.1
(78.62 to 98.34)
93.5
(78.58 to 99.21)
C Clade C (1086C) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
97.7
(87.98 to 99.94)
C Clade C (1086C) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
100.0
(92.29 to 100.0)
97.1
(85.08 to 99.93)
100.0
(91.78 to 100.0)
97.5
(86.84 to 99.94)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
97.6
(87.43 to 99.94)
2.5
(0.06 to 13.16)
C Clade C (1086C) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
100.0
(90.97 to 100.0)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
97.0
(84.24 to 99.92)
0
(0 to 9.74)
C Clade C (1086C) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
100.0
(90.97 to 100.0)
100.0
(89.42 to 100.0)
C Clade C (1086C) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
100.0
(90.75 to 100.0)
96.8
(83.3 to 99.92)
C Clade C (BF1266) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
93.2
(81.34 to 98.57)
C Clade C (BF1266) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
95.7
(85.16 to 99.47)
97.1
(85.08 to 99.93)
97.7
(87.71 to 99.94)
92.5
(79.61 to 98.43)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
92.9
(80.52 to 98.5)
2.5
(0.06 to 13.16)
C Clade C (BF1266) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
100.0
(90.97 to 100.0)
100.0
(89.72 to 100.0)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
97.0
(84.24 to 99.92)
2.8
(0.07 to 14.53)
C Clade C (BF1266) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.3
(79.13 to 98.38)
100.0
(89.42 to 100.0)
C Clade C (BF1266) IgG-t Ab at Week 96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.1
(78.62 to 98.34)
93.5
(78.58 to 99.21)
CF Clade AE (conAE) IgG-t Ab at 16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
88.6
(75.44 to 96.21)
CF Clade AE (conAE) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
95.7
(85.16 to 99.47)
97.1
(85.08 to 99.93)
93.0
(80.94 to 98.54)
90.0
(76.34 to 97.21)
85.7
(69.74 to 95.19)
97.4
(86.19 to 99.93)
95.2
(83.84 to 99.42)
0
(0 to 8.81)
CF Clade AE (conAE) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
92.3
(79.13 to 98.38)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
97.4
(86.19 to 99.93)
97.0
(84.24 to 99.92)
0
(0 to 9.74)
CF Clade AE (conAE) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
92.3
(79.13 to 98.38)
97.0
(84.24 to 99.92)
CF Clade AE (conAE) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
84.2
(68.75 to 93.98)
87.1
(70.17 to 96.37)
CFI Clade M(Con S) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
97.7
(87.98 to 99.94)
CFI Clade M(Con S) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
100.0
(92.29 to 100.0)
97.1
(85.08 to 99.93)
100.0
(91.78 to 100.0)
97.5
(86.84 to 99.94)
88.6
(73.26 to 96.8)
100.0
(90.75 to 100.0)
97.6
(87.43 to 99.94)
0
(0 to 8.81)
CFI Clade M(Con S) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
100.0
(90.97 to 100.0)
97.1
(84.67 to 99.93)
100.0
(89.42 to 100.0)
100.0
(90.75 to 100.0)
100.0
(89.42 to 100.0)
0
(0 to 9.74)
CFI Clade M(Con S) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
100.0
(90.97 to 100.0)
100.0
(89.42 to 100.0)
CFI Clade M(Con S) IgG-t Ab at Week 96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
100.0
(90.75 to 100.0)
96.8
(83.3 to 99.92)
IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
72.7
(57.21 to 85.04)
IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
95.7
(85.16 to 99.47)
88.6
(73.26 to 96.8)
79.1
(63.96 to 89.96)
87.5
(73.2 to 95.81)
85.7
(69.74 to 95.19)
89.5
(75.2 to 97.06)
90.5
(77.38 to 97.34)
0
(0 to 8.81)
IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
100.0
(90.51 to 100.0)
100.0
(89.11 to 100.0)
89.7
(75.78 to 97.13)
97.1
(84.67 to 99.93)
97.0
(84.24 to 99.92)
92.1
(78.62 to 98.34)
97.0
(84.24 to 99.92)
5.6
(0.68 to 18.66)
IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
87.2
(72.57 to 95.7)
81.8
(64.54 to 93.02)
IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
81.6
(65.67 to 92.26)
67.7
(48.63 to 83.32)
Clade A (191084) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
47.7
(32.46 to 63.31)
Clade A (191084) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
65.2
(49.75 to 78.65)
45.7
(28.83 to 63.35)
46.5
(31.18 to 62.35)
60.0
(43.33 to 75.14)
42.9
(26.32 to 60.65)
47.4
(30.98 to 64.18)
38.1
(23.57 to 54.36)
0
(0 to 8.81)
Clade A (191084) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
81.1
(64.84 to 92.04)
62.5
(43.69 to 78.9)
59.0
(42.1 to 74.43)
73.5
(55.64 to 87.12)
75.8
(57.74 to 88.91)
57.9
(40.82 to 73.69)
51.5
(33.54 to 69.2)
0
(0 to 9.74)
Clade A (191084) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
28.2
(15 to 44.87)
18.2
(6.98 to 35.46)
Clade A (191084) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
21.1
(9.55 to 37.32)
16.1
(5.45 to 33.73)
Clade AE (C2101) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
47.7
(32.46 to 63.31)
Clade AE (C2101) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
58.7
(43.23 to 73)
45.7
(28.83 to 63.35)
48.8
(33.31 to 64.54)
62.5
(45.8 to 77.27)
48.6
(31.38 to 66.01)
52.6
(35.82 to 69.02)
28.6
(15.72 to 44.58)
0
(0 to 8.81)
Clade AE (C2101) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
73.0
(55.88 to 86.21)
59.4
(40.64 to 76.3)
61.5
(44.62 to 76.64)
79.4
(62.1 to 91.3)
69.7
(51.29 to 84.41)
55.3
(38.3 to 71.38)
36.4
(20.4 to 54.88)
2.8
(0.07 to 14.53)
Clade AE (C2101) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
28.2
(15 to 44.87)
30.3
(15.59 to 48.71)
Clade AE (C2101) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
21.1
(9.55 to 37.32)
32.3
(16.68 to 51.37)
Clade AE (CM244) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
47.7
(32.46 to 63.31)
Clade AE (CM244) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 34 participants 38 participants 42 participants 40 participants
58.7
(43.23 to 73)
37.1
(21.47 to 55.08)
46.5
(31.18 to 62.35)
57.5
(40.89 to 72.96)
29.4
(15.1 to 47.48)
42.1
(26.31 to 59.18)
28.6
(15.72 to 44.58)
0
(0 to 8.81)
Clade AE (CM244) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
83.8
(67.99 to 93.81)
56.3
(37.66 to 73.64)
56.4
(39.62 to 72.19)
76.5
(58.83 to 89.25)
57.6
(39.22 to 74.52)
57.9
(40.82 to 73.69)
42.4
(25.48 to 60.78)
0
(0 to 9.74)
Clade AE (CM244) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
23.1
(11.13 to 39.33)
12.1
(3.4 to 28.2)
Clade AE (CM244) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
21.1
(9.55 to 37.32)
16.1
(5.45 to 33.73)
Clade B (62357.14) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
22.7
(11.47 to 37.84)
Clade B (62357.14) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
41.3
(27 to 56.77)
17.1
(6.56 to 33.65)
16.3
(6.81 to 30.7)
37.5
(22.73 to 54.2)
20.0
(8.44 to 36.94)
23.7
(11.44 to 40.24)
19.0
(8.6 to 34.12)
0
(0 to 8.81)
Clade B (62357.14) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
59.5
(42.1 to 75.25)
34.4
(18.57 to 53.19)
20.5
(9.3 to 36.46)
61.8
(43.56 to 77.83)
45.5
(28.11 to 63.65)
26.3
(13.4 to 43.1)
36.4
(20.4 to 54.88)
0
(0 to 9.74)
Clade B (62357.14) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
20.5
(9.3 to 36.46)
9.1
(1.92 to 24.33)
Clade B (62357.14) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
10.5
(2.94 to 24.8)
12.9
(3.63 to 29.83)
Clade B (CaseA) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
59.1
(43.25 to 73.66)
Clade B (CaseA) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
67.4
(51.98 to 80.47)
51.4
(33.99 to 68.62)
62.8
(46.73 to 77.02)
65.0
(48.32 to 79.37)
42.9
(26.32 to 60.65)
63.2
(45.99 to 78.19)
45.2
(29.85 to 61.33)
0
(0 to 8.81)
Clade B (CaseA) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
86.5
(71.23 to 95.46)
75.0
(56.6 to 88.54)
71.8
(55.13 to 85)
70.6
(52.52 to 84.9)
81.8
(64.54 to 93.02)
71.1
(54.1 to 84.58)
60.6
(42.14 to 77.09)
13.9
(4.67 to 29.5)
Clade B (CaseA) IgG-t Ab at W78 Number Analyzed 38 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
42.1
(26.31 to 59.18)
30.3
(15.59 to 48.71)
Clade B (CaseA) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
28.9
(15.42 to 45.9)
29.0
(14.22 to 48.04)
Clade B (RHPA4259) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
50.0
(34.56 to 65.44)
Clade B (RHPA4259) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 34 participants 38 participants 42 participants 40 participants
69.6
(54.25 to 82.26)
48.6
(31.38 to 66.01)
51.2
(35.46 to 66.69)
60.0
(43.33 to 75.14)
47.1
(29.78 to 64.87)
50.0
(33.38 to 66.62)
35.7
(21.55 to 51.97)
0
(0 to 8.81)
Clade B (RHPA4259) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
83.8
(67.99 to 93.81)
59.4
(40.64 to 76.3)
59.0
(42.1 to 74.43)
67.6
(49.47 to 82.61)
75.8
(57.74 to 88.91)
57.9
(40.82 to 73.69)
48.5
(30.8 to 66.46)
0
(0 to 9.74)
Clade B (RHPA4259) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
33.3
(19.09 to 50.22)
18.2
(6.98 to 35.46)
Clade B (RHPA4259) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
28.9
(15.42 to 45.9)
22.6
(9.59 to 41.1)
Clade B (TT31P) gp70 IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
59.1
(43.25 to 73.66)
Clade B (TT31P) gp70 IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
69.6
(54.25 to 82.26)
45.7
(28.83 to 63.35)
51.2
(35.46 to 66.69)
62.5
(45.8 to 77.27)
37.1
(21.47 to 55.08)
50.0
(33.38 to 66.62)
50.0
(34.19 to 65.81)
0
(0 to 8.81)
Clade B (TT31P) gp70 IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
86.5
(71.23 to 95.46)
62.5
(43.69 to 78.9)
66.7
(49.78 to 80.91)
73.5
(55.64 to 87.12)
75.8
(57.74 to 88.91)
57.9
(40.82 to 73.69)
57.6
(39.22 to 74.52)
2.8
(0.07 to 14.53)
Clade B (TT31P) gp70 IgG-t Ab at W78 Number Analyzed 38 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
36.8
(21.81 to 54.01)
24.2
(11.09 to 42.26)
Clade B (TT31P) gp70 IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
31.6
(17.5 to 48.65)
22.6
(9.59 to 41.1)
Clade B(700010058) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
50.0
(34.56 to 65.44)
Clade B(700010058) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
60.9
(45.37 to 74.91)
45.7
(28.83 to 63.35)
53.5
(37.65 to 68.82)
62.5
(45.8 to 77.27)
37.1
(21.47 to 55.08)
50.0
(33.38 to 66.62)
26.2
(13.86 to 42.04)
0
(0 to 8.81)
Clade B(700010058) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
64.9
(47.46 to 79.79)
62.5
(43.69 to 78.9)
64.1
(47.18 to 78.8)
70.6
(52.52 to 84.9)
66.7
(48.17 to 82.04)
57.9
(40.82 to 73.69)
33.3
(17.96 to 51.83)
0
(0 to 9.74)
Clade B(700010058) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
28.2
(15 to 44.87)
30.3
(15.59 to 48.71)
Clade B(700010058) IgG-t Ab at W96 Number Analyzed 37 participants 30 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
27.0
(13.79 to 44.12)
23.3
(9.93 to 42.28)
Clade BC (BJOX) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
52.3
(36.69 to 67.54)
Clade BC (BJOX) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
67.4
(51.98 to 80.47)
48.6
(31.38 to 66.01)
55.8
(39.88 to 70.92)
62.5
(45.8 to 77.27)
40.0
(23.87 to 57.89)
47.4
(30.98 to 64.18)
35.7
(21.55 to 51.97)
0
(0 to 8.81)
Clade BC (BJOX) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
81.1
(64.84 to 92.04)
62.5
(43.69 to 78.9)
66.7
(49.78 to 80.91)
70.6
(52.52 to 84.9)
66.7
(48.17 to 82.04)
60.5
(43.39 to 75.96)
54.5
(36.35 to 71.89)
2.8
(0.07 to 14.53)
Clade BC (BJOX) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
23.1
(11.13 to 39.33)
18.2
(6.98 to 35.46)
Clade BC (BJOX) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
21.1
(9.55 to 37.32)
22.6
(9.59 to 41.1)
Clade C (96ZM651) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
13.6
(5.17 to 27.35)
Clade C (96ZM651) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
28.3
(15.99 to 43.46)
17.1
(6.56 to 33.65)
4.7
(0.57 to 15.81)
32.5
(18.57 to 49.13)
20.0
(8.44 to 36.94)
18.4
(7.74 to 34.33)
14.3
(5.43 to 28.54)
0
(0 to 8.81)
Clade C (96ZM651) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
54.1
(36.92 to 70.51)
40.6
(23.7 to 59.36)
20.5
(9.3 to 36.46)
61.8
(43.56 to 77.83)
36.4
(20.4 to 54.88)
36.8
(21.81 to 54.01)
30.3
(15.59 to 48.71)
2.8
(0.07 to 14.53)
Clade C (96ZM651) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
10.3
(2.87 to 24.22)
9.1
(1.92 to 24.33)
Clade C (96ZM651) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
10.5
(2.94 to 24.8)
6.5
(0.79 to 21.42)
Clade C (BF1266) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
43.2
(28.35 to 58.97)
Clade C (BF1266) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
58.7
(43.23 to 73)
31.4
(16.85 to 49.29)
30.2
(17.18 to 46.13)
50.0
(33.8 to 66.2)
34.3
(19.13 to 52.21)
34.2
(19.63 to 51.35)
31.0
(17.62 to 47.09)
0
(0 to 8.81)
Clade C (BF1266) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
78.4
(61.79 to 90.17)
43.8
(26.36 to 62.34)
43.6
(27.81 to 60.38)
70.6
(52.52 to 84.9)
51.5
(33.54 to 69.2)
42.1
(26.31 to 59.18)
48.5
(30.8 to 66.46)
0
(0 to 9.74)
Clade C (BF1266) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
17.9
(7.54 to 33.53)
18.2
(6.98 to 35.46)
Clade C (BF1266) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
18.4
(7.74 to 34.33)
22.6
(9.59 to 41.1)
Clade C (CAP210) IgG-t Ab at W16 Number Analyzed 44 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
34.1
(20.49 to 49.92)
Clade C (CAP210) IgG-t Ab at W28 Number Analyzed 46 participants 35 participants 43 participants 40 participants 35 participants 38 participants 42 participants 40 participants
47.8
(32.89 to 63.05)
42.9
(26.32 to 60.65)
32.6
(19.08 to 48.54)
50.0
(33.8 to 66.2)
25.7
(12.49 to 43.26)
21.1
(9.55 to 37.32)
26.2
(13.86 to 42.04)
0
(0 to 8.81)
Clade C (CAP210) IgG-t Ab at W52 Number Analyzed 37 participants 32 participants 39 participants 34 participants 33 participants 38 participants 33 participants 36 participants
67.6
(50.21 to 81.99)
53.1
(34.74 to 70.91)
43.6
(27.81 to 60.38)
67.6
(49.47 to 82.61)
51.5
(33.54 to 69.2)
39.5
(24.04 to 56.61)
48.5
(30.8 to 66.46)
0
(0 to 9.74)
Clade C (CAP210) IgG-t Ab at W78 Number Analyzed 39 participants 33 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
25.6
(13.04 to 42.13)
18.2
(6.98 to 35.46)
Clade C (CAP210) IgG-t Ab at W96 Number Analyzed 38 participants 31 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
21.1
(9.55 to 37.32)