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Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa (HVTN702)

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: NCT02968849
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : February 8, 2023
Last Update Posted : February 8, 2023
Sponsor:
Collaborators:
Sanofi
GlaxoSmithKline
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Biological: ALVAC-HIV (vCP2438)
Biological: Bivalent Subtype C gp120/MF59
Biological: Placebo
Enrollment 5404
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18 Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Period Title: Overall Study
Started 2704 2700
Modified Intent-to-Treat (MITT) Cohort 2695 2689
MITT Infected Cohort 151 143
Week 26 At-Risk Cohort 2430 2393
Immunogenicity Cohort 120 10
Completed 2557 2557
Not Completed 147 143
Reason Not Completed
Death             8             10
Lost to Follow-up             31             29
Withdrawal by Subject             73             64
Participant Unable to Adhere to Visit Schedule             13             21
Physician Decision             6             9
Other             16             10
Arm/Group Title Vaccine Placebo Total
Hide Arm/Group Description ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18 Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18 Total of all reporting groups
Overall Number of Baseline Participants 2704 2700 5404
Hide Baseline Analysis Population Description
Safety Cohort
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Female Number Analyzed 2704 participants 2700 participants 5404 participants
24
(18 to 35)
23
(18 to 35)
24
(18 to 35)
Male Number Analyzed 2704 participants 2700 participants 5404 participants
26
(18 to 35)
26
(18 to 35)
26
(18 to 35)
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 1893 participants 1893 participants 3786 participants
18 - 20 years
349
  18.4%
392
  20.7%
741
  19.6%
21 - 25 years
917
  48.4%
877
  46.3%
1794
  47.4%
26 - 30 years
465
  24.6%
461
  24.4%
926
  24.5%
31 - 35 years
162
   8.6%
163
   8.6%
325
   8.6%
Male Number Analyzed 811 participants 807 participants 1618 participants
18 - 20 years
114
  14.1%
98
  12.1%
212
  13.1%
21 - 25 years
271
  33.4%
276
  34.2%
547
  33.8%
26 - 30 years
244
  30.1%
254
  31.5%
498
  30.8%
31 - 35 years
182
  22.4%
179
  22.2%
361
  22.3%
[1]
Measure Analysis Population Description: Age categories are summarized separately within females and males.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2704 participants 2700 participants 5404 participants
Female
1893
  70.0%
1893
  70.1%
3786
  70.1%
Male
811
  30.0%
807
  29.9%
1618
  29.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2704 participants 2700 participants 5404 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2704
 100.0%
2700
 100.0%
5404
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Black Number Analyzed 2704 participants 2700 participants 5404 participants
2672
  98.8%
2676
  99.1%
5348
  99.0%
Colored/Mixed Number Analyzed 2704 participants 2700 participants 5404 participants
23
   0.9%
17
   0.6%
40
   0.7%
White Number Analyzed 2704 participants 2700 participants 5404 participants
3
   0.1%
3
   0.1%
6
   0.1%
Indian Number Analyzed 2704 participants 2700 participants 5404 participants
1
   0.0%
1
   0.0%
2
   0.0%
Asian Number Analyzed 2704 participants 2700 participants 5404 participants
0
   0.0%
1
   0.0%
1
   0.0%
More than one race Number Analyzed 2704 participants 2700 participants 5404 participants
5
   0.2%
2
   0.1%
7
   0.1%
Unknown or Not Reported Number Analyzed 2704 participants 2700 participants 5404 participants
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 2704 participants 2700 participants 5404 participants
2704 2700 5404
1.Primary Outcome
Title Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment
Hide Description Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
Time Frame Measured through 24 months after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
MITT cohort
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2695 2689
Measure Type: Number
Unit of Measure: events per 100 person-years
Cox PH method 0.034 0.033
CIR method 0.034 0.033
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Log Rank
Comments The hazard ratio was tested using a sex-stratified log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.81 to 1.30
Estimation Comments The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Wald
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.81 to 1.31
Estimation Comments The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..
2.Primary Outcome
Title Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Hide Description Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.
Time Frame Measured through 3 full days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Pain None
2161
  79.9%
2539
  94.0%
Mild
480
  17.8%
149
   5.5%
Moderate
62
   2.3%
12
   0.4%
Severe
1
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Tenderness None
2368
  87.6%
2600
  96.3%
Mild
297
  11.0%
91
   3.4%
Moderate
38
   1.4%
9
   0.3%
Severe
1
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Pain and/or Tenderness None
2082
  77.0%
2493
  92.3%
Mild
552
  20.4%
194
   7.2%
Moderate
69
   2.6%
13
   0.5%
Severe
1
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Hide Description Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.
Time Frame Measured through 3 full days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema/Redness None / Not Gradable
2494
  92.2%
2683
  99.4%
Gr 1: 2.5 - <5cm / 6.25 - <25cm^2
108
   4.0%
14
   0.5%
Gr 2: 5 - <10cm / 25 - <100cm^2
74
   2.7%
3
   0.1%
Gr 3: >=10cm / >=100cm^2 / Complications
28
   1.0%
0
   0.0%
Gr 4: Complications
0
   0.0%
0
   0.0%
Induration/Swelling None / Not Gradable
2380
  88.0%
2675
  99.1%
Gr 1: 2.5 - <5cm / 6.25 - <25cm^2
159
   5.9%
16
   0.6%
Gr 2: 5 - <10cm / 25 - <100cm^2
133
   4.9%
7
   0.3%
Gr 3: >=10cm / >=100cm^2 / Complications
32
   1.2%
2
   0.1%
Gr 4: Complications
0
   0.0%
0
   0.0%
Erythema and/or Induration None / Not Gradable
2314
  85.6%
2662
  98.6%
Gr 1: 2.5 - <5cm / 6.25 - <25cm^2
196
   7.2%
26
   1.0%
Gr 2: 5 - <10cm / 25 - <100cm^2
156
   5.8%
10
   0.4%
Gr 3: >=10cm / >=100cm^2 / Complications
38
   1.4%
2
   0.1%
Gr 4: Complications
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Hide Description Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.
Time Frame Measured through 3 full days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia None
2622
  97.0%
2649
  98.1%
Mild
75
   2.8%
40
   1.5%
Moderate
7
   0.3%
11
   0.4%
Severe
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Chills None
2614
  96.7%
2641
  97.8%
Mild
87
   3.2%
51
   1.9%
Moderate
3
   0.1%
8
   0.3%
Severe
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Headache None
2267
  83.8%
2276
  84.3%
Mild
317
  11.7%
311
  11.5%
Moderate
117
   4.3%
112
   4.1%
Severe
3
   0.1%
1
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Malaise and/or fatigue None
2461
  91.0%
2497
  92.5%
Mild
221
   8.2%
177
   6.6%
Moderate
21
   0.8%
24
   0.9%
Severe
1
   0.0%
2
   0.1%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Myalgia None
2604
  96.3%
2644
  97.9%
Mild
85
   3.1%
48
   1.8%
Moderate
15
   0.6%
8
   0.3%
Severe
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Nausea None
2585
  95.6%
2583
  95.7%
Mild
104
   3.8%
107
   4.0%
Moderate
15
   0.6%
10
   0.4%
Severe
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Vomiting None
2625
  97.1%
2629
  97.4%
Mild
64
   2.4%
64
   2.4%
Moderate
15
   0.6%
7
   0.3%
Severe
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Max. Systemic Symptoms (excl. Temp.) None
2004
  74.1%
2095
  77.6%
Mild
545
  20.2%
459
  17.0%
Moderate
151
   5.6%
143
   5.3%
Severe
4
   0.1%
3
   0.1%
Potentially Life-threatening
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Temperature None
2409
  89.1%
2406
  89.1%
Mild
168
   6.2%
176
   6.5%
Moderate
98
   3.6%
84
   3.1%
Severe
19
   0.7%
15
   0.6%
Potentially Life-threatening
1
   0.0%
5
   0.2%
Missing
9
   0.3%
14
   0.5%
5.Primary Outcome
Title Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Hide Description For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Time Frame Measured through 30 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Related
38
   1.4%
12
   0.4%
Not Related
1689
  62.5%
1722
  63.8%
No AE Reported
977
  36.1%
966
  35.8%
6.Primary Outcome
Title Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Hide Description For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Time Frame Measured through 30 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
161
   6.0%
137
   5.1%
Moderate
1443
  53.4%
1472
  54.5%
Severe
98
   3.6%
103
   3.8%
Potentially life-threatening
17
   0.6%
12
   0.4%
Death
8
   0.3%
10
   0.4%
No AE Reported
977
  36.1%
966
  35.8%
7.Primary Outcome
Title Number of Participants Reporting Serious Adverse Events (SAEs)
Hide Description Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
Time Frame Measured through 12 months after last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
103
   3.8%
95
   3.5%
No
1624
  60.1%
1639
  60.7%
No AE Reported
977
  36.1%
966
  35.8%
8.Primary Outcome
Title Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Hide Description Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
Time Frame Measured through 12 months after last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
4
   0.1%
2
   0.1%
No
1693
  62.6%
1700
  63.0%
No AE Reported
1007
  37.2%
998
  37.0%
9.Primary Outcome
Title Number of Participants Reporting New Chronic Medical Conditions
Hide Description A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days.
Time Frame Measured through 12 months after last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
54
   2.0%
54
   2.0%
No
1673
  61.9%
1680
  62.2%
No AE Reported
977
  36.1%
966
  35.8%
10.Primary Outcome
Title Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Hide Description From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group.
Time Frame Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Termination associated with adverse event or reactogenicity
9
   0.3%
14
   0.5%
Other reason
140
   5.2%
129
   4.8%
No discontinuation
2555
  94.5%
2557
  94.7%
11.Primary Outcome
Title Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Hide Description From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group.
Time Frame Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2704 2700
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical event other than reactogenicity, HIV, infection or death
8
   0.3%
6
   0.2%
Reactogenicity symptom
4
   0.1%
1
   0.0%
Other reason
539
  19.9%
598
  22.1%
No discontinuation
2153
  79.6%
2095
  77.6%
12.Primary Outcome
Title Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up
Hide Description Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
Time Frame Measured through 36 months after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
MITT cohort
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2695 2689
Measure Type: Number
Unit of Measure: events per 100 person-years
Cox PH method 0.032 0.03
CIR method 0.038 0.03
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Log Rank
Comments The hazard ratio was tested using a sex-stratified log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.85 to 1.28
Estimation Comments The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Wald
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.81 to 1.23
Estimation Comments The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..
13.Secondary Outcome
Title Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment
Hide Description This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.
Time Frame Measured through 36 months after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
Hide Arm/Group Description:
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, 12, and 18 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5 mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, 12, and 18
Placebo for ALVAC-HIV (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, 12, and 18 AND Placebo for Bivalent Subtype C gp120/MF59 (Sodium Chloride for Injection, 0.9%) administered as 0.5 mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, 12, and 18
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment
Hide Description Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
Time Frame Measured after Month 6.5 through 24 months after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Week 26 at-risk cohort
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 2430 2393
Measure Type: Number
Unit of Measure: events per 100 person-years
Cox PH method 0.03 0.026
CIR method 0.03 0.026
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Log Rank
Comments The hazard ratio was tested using a sex-stratified log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.84 to 1.58
Estimation Comments The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wald
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.81 to 1.54
Estimation Comments The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..
15.Secondary Outcome
Title Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5
Hide Description PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 119 10
Measure Type: Count of Participants
Unit of Measure: Participants
CD4+ : 1086 gp120 Number Analyzed 117 participants 10 participants
65
  55.6%
0
   0.0%
CD4+ : ANY ENV Number Analyzed 117 participants 10 participants
88
  75.2%
0
   0.0%
CD4+ : ANY HIV Number Analyzed 117 participants 10 participants
89
  76.1%
0
   0.0%
CD4+ : LAI Gag Number Analyzed 117 participants 10 participants
4
   3.4%
0
   0.0%
CD4+ : TV1 gp120 Number Analyzed 117 participants 10 participants
86
  73.5%
0
   0.0%
CD4+ : ZM96 gp120 Number Analyzed 117 participants 10 participants
78
  66.7%
0
   0.0%
CD8+ : 1086 gp120 Number Analyzed 118 participants 10 participants
2
   1.7%
0
   0.0%
CD8+ : ANY ENV Number Analyzed 118 participants 10 participants
13
  11.0%
0
   0.0%
CD8+ : ANY HIV Number Analyzed 118 participants 10 participants
15
  12.7%
0
   0.0%
CD8+ : LAI Gag Number Analyzed 117 participants 10 participants
4
   3.4%
0
   0.0%
CD8+ : TV1 gp120 Number Analyzed 118 participants 10 participants
4
   3.4%
0
   0.0%
CD8+ : ZM96 gp120 Number Analyzed 117 participants 10 participants
11
   9.4%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5
Hide Description PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 119 10
Measure Type: Count of Participants
Unit of Measure: Participants
CD4+ : 1086 gp120 Number Analyzed 117 participants 10 participants
86
  73.5%
0
   0.0%
CD4+ : ANY ENV Number Analyzed 117 participants 10 participants
103
  88.0%
0
   0.0%
CD4+ : ANY HIV Number Analyzed 117 participants 10 participants
103
  88.0%
0
   0.0%
CD4+ : LAI Gag Number Analyzed 117 participants 10 participants
7
   6.0%
0
   0.0%
CD4+ : TV1 gp120 Number Analyzed 117 participants 10 participants
99
  84.6%
0
   0.0%
CD4+ : ZM96 gp120 Number Analyzed 117 participants 10 participants
88
  75.2%
0
   0.0%
CD8+ : 1086 gp120 Number Analyzed 118 participants 10 participants
5
   4.2%
0
   0.0%
CD8+ : ANY ENV Number Analyzed 118 participants 10 participants
16
  13.6%
0
   0.0%
CD8+ : ANY HIV Number Analyzed 118 participants 10 participants
17
  14.4%
0
   0.0%
CD8+ : LAI Gag Number Analyzed 117 participants 10 participants
3
   2.6%
0
   0.0%
CD8+ : TV1 gp120 Number Analyzed 118 participants 10 participants
6
   5.1%
0
   0.0%
CD8+ : ZM96 gp120 Number Analyzed 117 participants 10 participants
11
   9.4%
0
   0.0%
17.Secondary Outcome
Title Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5
Hide Description PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 119
Median (Inter-Quartile Range)
Unit of Measure: % T-Cells
CD4+ : 1086 gp120 Number Analyzed 65 participants
0.1
(0.1 to 0.2)
CD4+ : ANY ENV Number Analyzed 88 participants
0.1
(0.1 to 0.2)
CD4+ : ANY HIV Number Analyzed 89 participants
0.2
(0.1 to 0.2)
CD4+ : LAI Gag Number Analyzed 4 participants
0.1
(0 to 0.1)
CD4+ : TV1 gp120 Number Analyzed 86 participants
0.1
(0.1 to 0.2)
CD4+ : ZM96 gp120 Number Analyzed 78 participants
0.1
(0.1 to 0.2)
CD8+ : 1086 gp120 Number Analyzed 2 participants
0.1
(0.1 to 0.1)
CD8+ : ANY ENV Number Analyzed 13 participants
0.1
(0.1 to 0.2)
CD8+ : ANY HIV Number Analyzed 15 participants
0.1
(0.1 to 0.2)
CD8+ : LAI Gag Number Analyzed 4 participants
0.1
(0.1 to 0.2)
CD8+ : TV1 gp120 Number Analyzed 4 participants
0.1
(0.1 to 0.1)
CD8+ : ZM96 gp120 Number Analyzed 11 participants
0.1
(0.1 to 0.2)
18.Secondary Outcome
Title Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5
Hide Description PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 119
Median (Inter-Quartile Range)
Unit of Measure: % T-Cells
CD4+ : 1086 gp120 Number Analyzed 86 participants
0.2
(0.1 to 0.3)
CD4+ : ANY ENV Number Analyzed 103 participants
0.2
(0.1 to 0.3)
CD4+ : ANY HIV Number Analyzed 103 participants
0.2
(0.2 to 0.4)
CD4+ : LAI Gag Number Analyzed 7 participants
0.1
(0.1 to 0.1)
CD4+ : TV1 gp120 Number Analyzed 99 participants
0.2
(0.1 to 0.3)
CD4+ : ZM96 gp120 Number Analyzed 88 participants
0.2
(0.1 to 0.3)
CD8+ : 1086 gp120 Number Analyzed 5 participants
0.1
(0.1 to 0.1)
CD8+ : ANY ENV Number Analyzed 16 participants
0.1
(0.1 to 0.2)
CD8+ : ANY HIV Number Analyzed 17 participants
0.2
(0.1 to 0.2)
CD8+ : LAI Gag Number Analyzed 3 participants
0.1
(0.1 to 0.3)
CD8+ : TV1 gp120 Number Analyzed 6 participants
0.1
(0.1 to 0.1)
CD8+ : ZM96 gp120 Number Analyzed 11 participants
0.1
(0.1 to 0.2)
19.Secondary Outcome
Title Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5
Hide Description Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1,and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 120 10
Measure Type: Count of Participants
Unit of Measure: Participants
HVTN 505 Env Breadth Panel : VRC A_avi Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
HVTN 505 Env Breadth Panel : VRC B gp140 Number Analyzed 117 participants 10 participants
116
  99.1%
0
   0.0%
HVTN 505 Env Breadth Panel : VRC C_avi Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : 00MSA 4076 gp140 Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : A244 gp 120 gDneg/293F/mon Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : B.con.env03 140 CF Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : C.con.env03 140 CF_avi Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : Con 6 gp120/B Number Analyzed 114 participants 9 participants
114
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : Con S gp140 CFI Number Analyzed 114 participants 9 participants
114
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : G.con.env03 140 CF Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : HV 13700 AE.con.env03 140 CF Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : HV 14000 (DRCBL) gp140 Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgG : 92TH023 gp120 gDneg 293F mon Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgG : A1.con.env03 140 CF Number Analyzed 117 participants 10 participants
117
 100.0%
0
   0.0%
RV144 CoR IgG : AE.A244 V1V2 Tags/293F Number Analyzed 117 participants 10 participants
103
  88.0%
0
   0.0%
RV144 CoR IgG : C.1086C_V1_V2 Tags Number Analyzed 117 participants 10 participants
86
  73.5%
0
   0.0%
RV144 CoR IgG : gp70-92TH023 V1V2 Number Analyzed 117 participants 10 participants
112
  95.7%
0
   0.0%
RV144 CoR IgG : gp70_B.CaseA_V1_V2 Number Analyzed 117 participants 10 participants
62
  53.0%
0
   0.0%
RV144 CoR IgG3 : gp70_B.CaseA2 V1/V2/169K Number Analyzed 117 participants 10 participants
63
  53.8%
0
   0.0%
RV144 CoR IgA : Bio-1086C C1_HS Number Analyzed 116 participants 10 participants
59
  50.9%
0
   0.0%
RV144 CoR IgA : Bio-92TH023 C1_HS Number Analyzed 116 participants 10 participants
96
  82.8%
0
   0.0%
RV144 CoR IgA : Bio-96ZM651 C1_HS Number Analyzed 116 participants 10 participants
92
  79.3%
0
   0.0%
RV144 CoR IgA : Bio-TV1 C1_HS Number Analyzed 116 participants 10 participants
42
  36.2%
0
   0.0%
Vaccine Matched Env : 1086C_D7gp120.avi/293F Number Analyzed 114 participants 9 participants
114
 100.0%
0
   0.0%
Vaccine Matched Env : 96ZM651.D11gp120.avi Number Analyzed 113 participants 9 participants
113
 100.0%
0
   0.0%
Vaccine Matched Env : TV1c8_D11gp120.avi/293F Number Analyzed 114 participants 9 participants
114
 100.0%
0
   0.0%
Vaccine Strain Matched V1V2 : gp70-96ZM651.02 V1v2 Number Analyzed 116 participants 10 participants
61
  52.6%
0
   0.0%
Vaccine Strain Matched V1V2 : gp70-TV1.GSKvacV1V2/293F Number Analyzed 117 participants 10 participants
73
  62.4%
0
   0.0%
Vaccine Strain Matched V1V2 : gp70_C.1086C V1/V2/293F Number Analyzed 117 participants 10 participants
103
  88.0%
0
   0.0%
gp41 Number Analyzed 117 participants 10 participants
1
   0.9%
0
   0.0%
20.Secondary Outcome
Title Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5
Hide Description Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:40 dilution.The readout is background-subtracted mean fluorescent intensity(MFI), with background adjustment for an antigen-specific plate level control.For each sample, response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline M
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 120 10
Measure Type: Count of Participants
Unit of Measure: Participants
HVTN 505 Env Breadth Panel : A1.con.env03 140 CF Number Analyzed 120 participants 10 participants
74
  61.7%
0
   0.0%
HVTN 505 Env Breadth Panel : B.con.env03 140 CF Number Analyzed 120 participants 10 participants
106
  88.3%
0
   0.0%
HVTN 505 Env Breadth Panel : C.con.env03 140 CF_avi Number Analyzed 120 participants 10 participants
87
  72.5%
0
   0.0%
HVTN 505 Env Breadth Panel : Con 6 gp120/B Number Analyzed 120 participants 10 participants
99
  82.5%
0
   0.0%
HVTN 505 Env Breadth Panel : Con S gp140 CFI Number Analyzed 120 participants 10 participants
115
  95.8%
0
   0.0%
HVTN 505 Env Breadth Panel : VRC A_avi Number Analyzed 120 participants 10 participants
72
  60.0%
0
   0.0%
HVTN 505 Env Breadth Panel : VRC B gp140 Number Analyzed 120 participants 10 participants
42
  35.0%
0
   0.0%
HVTN 505 Env Breadth Panel : VRC C_avi Number Analyzed 120 participants 10 participants
68
  56.7%
0
   0.0%
RV144 CoR IgG3 : C.1086C_V1_V2 Tags Number Analyzed 120 participants 10 participants
32
  26.7%
0
   0.0%
RV144 CoR IgG3 : gp70_B.CaseA2 V1/V2/169K Number Analyzed 120 participants 10 participants
9
   7.5%
0
   0.0%
RV144 CoR IgG3 : gp70_B.CaseA_V1_V2 Number Analyzed 120 participants 10 participants
8
   6.7%
0
   0.0%
V1V2 Subtype AW : AE.A244 V1V2 Tags/293F Number Analyzed 120 participants 10 participants
49
  40.8%
0
   0.0%
Vaccine Matched Env : 1086C_D7gp120.avi/293F Number Analyzed 120 participants 10 participants
120
 100.0%
0
   0.0%
Vaccine Matched Env : 96ZM651.D11gp120.avi Number Analyzed 120 participants 10 participants
110
  91.7%
0
   0.0%
Vaccine Matched Env : TV1c8_D11gp120.avi/293F Number Analyzed 120 participants 10 participants
118
  98.3%
0
   0.0%
Vaccine Strain Matched V1V2 : gp70-96ZM651.02 V1v2 Number Analyzed 118 participants 10 participants
10
   8.5%
0
   0.0%
Vaccine Strain Matched V1V2 : gp70-TV1.GSKvacV1V2/293F Number Analyzed 118 participants 10 participants
12
  10.2%
0
   0.0%
Vaccine Strain Matched V1V2 : gp70_C.1086C V1/V2/293F Number Analyzed 120 participants 10 participants
54
  45.0%
0
   0.0%
21.Secondary Outcome
Title Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5
Hide Description Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:10 dilution.The readout is background-subtracted mean fluorescent intensity (MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 120 10
Measure Type: Count of Participants
Unit of Measure: Participants
Bio-1086C C1_HS Number Analyzed 120 participants 10 participants
0
   0.0%
0
   0.0%
Bio-96ZM651 C1_HS Number Analyzed 120 participants 10 participants
0
   0.0%
0
   0.0%
Bio-TV1 C1_HS Number Analyzed 120 participants 10 participants
0
   0.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : 00MSA 4076 gp140 Number Analyzed 120 participants 10 participants
60
  50.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : 92TH023 gp120 gDneg 293F mon Number Analyzed 120 participants 10 participants
48
  40.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : A1.con.env03 140 CF Number Analyzed 120 participants 10 participants
72
  60.0%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : A244 gp 120 gDneg/293F/mon Number Analyzed 120 participants 10 participants
34
  28.3%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : B.con.env03 140 CF Number Analyzed 120 participants 10 participants
83
  69.2%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : C.con.env03 140 CF_avi Number Analyzed 120 participants 10 participants
75
  62.5%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : Con 6 gp120/B Number Analyzed 120 participants 10 participants
68
  56.7%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : Con S gp140 CFI Number Analyzed 120 participants 10 participants
95
  79.2%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : G.con.env03 140 CF Number Analyzed 120 participants 10 participants
73
  60.8%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : HV 13700 AE.con.env03 140 CF Number Analyzed 120 participants 10 participants
41
  34.2%
0
   0.0%
RV144 CoR IgA Primary gp120 Score : HV 14000 (DRCBL) gp140 Number Analyzed 120 participants 10 participants
65
  54.2%
0
   0.0%
RV144 CoR IgA : Bio-92TH023 C1_HS Number Analyzed 120 participants 10 participants
0
   0.0%
0
   0.0%
Vaccine Matched Env : 1086C_D7gp120.avi/293F Number Analyzed 120 participants 10 participants
114
  95.0%
0
   0.0%
Vaccine Matched Env : 96ZM651.D11gp120.avi Number Analyzed 120 participants 9 participants
82
  68.3%
0
   0.0%
Vaccine Matched Env : TV1c8_D11gp120.avi/293F Number Analyzed 120 participants 10 participants
90
  75.0%
0
   0.0%
gp41 Number Analyzed 118 participants 10 participants
0
   0.0%
0
   0.0%
gp70-96ZM651.02 V1v2 Number Analyzed 118 participants 10 participants
1
   0.8%
0
   0.0%
gp70-TV1.GSKvacV1V2/293F Number Analyzed 119 participants 10 participants
4
   3.4%
0
   0.0%
gp70_C.1086C V1/V2/293F Number Analyzed 109 participants 10 participants
13
  11.9%
0
   0.0%
22.Secondary Outcome
Title Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5
Hide Description Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 and 1:100 dilutions. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 120
Median (Inter-Quartile Range)
Unit of Measure: net mean fluorescent intensity (net MFI)
HVTN 505 Env Breadth Panel: VRC A_avi, dilution 1: 50 Number Analyzed 117 participants
20132
(8982.8 to 22000)
HVTN 505 Env Breadth Panel: VRC A_avi, dilution 1:100 Number Analyzed 117 participants
10290
(4369.2 to 20537.2)
HVTN 505 Env Breadth Panel: VRC B gp140, dilution 1: 50 Number Analyzed 116 participants
7503.5
(4020.5 to 13312.1)
HVTN 505 Env Breadth Panel: VRC B gp140, dilution 1:100 Number Analyzed 116 participants
3708.5
(1640.5 to 7191.8)
HVTN 505 Env Breadth Panel: VRC C_avi, dilution 1: 50 Number Analyzed 117 participants
12765
(7504.8 to 20089.5)
HVTN 505 Env Breadth Panel: VRC C_avi, dilution 1:100 Number Analyzed 117 participants
6247.2
(3347.5 to 11681.8)
RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140, dilution 1: 50 Number Analyzed 117 participants
17184
(9261.5 to 22000)
RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140, dilution 1:100 Number Analyzed 117 participants
8842.2
(4311.8 to 16801.8)
RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon, dilution 1: 50 Number Analyzed 117 participants
18126.8
(11247.2 to 22000)
RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon, dilution 1:100 Number Analyzed 117 participants
8697.2
(5161.8 to 16319.8)
RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF, dilution 1: 50 Number Analyzed 117 participants
22000
(19561 to 22000)
RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF, dilution 1:100 Number Analyzed 117 participants
21073.2
(10314.8 to 22000)
RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi, dilution 1: 50 Number Analyzed 117 participants
19326.2
(11303.5 to 22000)
RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi, dilution 1:100 Number Analyzed 117 participants
11210.5
(5829.5 to 17740)
RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B, dilution 1: 50 Number Analyzed 114 participants
15732
(9491.3 to 20903.4)
RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B, dilution 1:100 Number Analyzed 114 participants
7617.4
(4618.9 to 11111.1)
RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI, dilution 1: 50 Number Analyzed 114 participants
22000
(22000 to 22000)
RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI, dilution 1:100 Number Analyzed 114 participants
22000
(20274.6 to 22000)
RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF, dilution 1: 50 Number Analyzed 117 participants
22000
(22000 to 22000)
RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF, dilution 1:100 Number Analyzed 117 participants
22000
(14411.5 to 22000)
RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF, dilution 1: 50 Number Analyzed 117 participants
15539.5
(8042 to 22000)
RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF, dilution 1:100 Number Analyzed 117 participants
6859
(3508.2 to 14297.2)
RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140, dilution 1: 50 Number Analyzed 117 participants
10932
(6895.2 to 19457.2)
RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140, dilution 1:100 Number Analyzed 117 participants
5141.5
(2910.8 to 9346.5)
RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K, dilution 1: 50 Number Analyzed 63 participants
1133.8
(416.2 to 4078.9)
RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K, dilution 1:100 Number Analyzed 63 participants
527.5
(202.1 to 1440.6)
RV144 CoR IgG: 92TH023 gp120 gDneg 293F mon, dilution 1: 50 Number Analyzed 117 participants
15096.5
(9387.8 to 22000)
RV144 CoR IgG: 92TH023 gp120 gDneg 293F mon, dilution 1:100 Number Analyzed 117 participants
7544.2
(4182.8 to 13109)
RV144 CoR IgG: A1.con.env03 140 CF, dilution 1: 50 Number Analyzed 117 participants
19319.5
(12159.5 to 22000)
RV144 CoR IgG: A1.con.env03 140 CF, dilution 1:100 Number Analyzed 117 participants
12505.2
(6220.2 to 19676.2)
RV144 CoR IgG: AE.A244 V1V2 Tags/293F, dilution 1: 50 Number Analyzed 103 participants
2659.8
(1054.1 to 7085.2)
RV144 CoR IgG: AE.A244 V1V2 Tags/293F, dilution 1:100 Number Analyzed 103 participants
1014.8
(430.4 to 2907.5)
RV144 CoR IgG: C.1086C_V1_V2 Tags, dilution 1: 50 Number Analyzed 86 participants
1273
(525.2 to 3343.3)
RV144 CoR IgG: C.1086C_V1_V2 Tags, dilution 1:100 Number Analyzed 86 participants
566.5
(266.3 to 1335.4)
RV144 CoR IgG: gp70-92TH023 V1V2, dilution 1: 50 Number Analyzed 112 participants
20359.2
(7733.3 to 22000)
RV144 CoR IgG: gp70-92TH023 V1V2, dilution 1:100 Number Analyzed 112 participants
7925.4
(2726.2 to 22000)
RV144 CoR IgG: gp70_B.CaseA_V1_V2, dilution 1: 50 Number Analyzed 62 participants
974.4
(360.8 to 3270.8)
RV144 CoR IgG: gp70_B.CaseA_V1_V2, dilution 1:100 Number Analyzed 62 participants
452.8
(173.9 to 1350.2)
RV144 CoR IgA: Bio-1086C C1_HS, dilution 1: 40 Number Analyzed 59 participants
657
(324.1 to 1034.6)
RV144 CoR IgA: Bio-92TH023 C1_HS, dilution 1: 40 Number Analyzed 96 participants
3345.5
(1613.6 to 6390.6)
RV144 CoR IgA: Bio-96ZM651 C1_HS, dilution 1: 40 Number Analyzed 92 participants
6250.6
(3556.6 to 11699.8)
RV144 CoR IgA: Bio-TV1 C1_HS, dilution 1: 40 Number Analyzed 42 participants
318
(232.2 to 556.9)
Vaccine Matched Env: 1086C_D7gp120.avi/293F, dilution 1: 50 Number Analyzed 114 participants
22000
(22000 to 22000)
Vaccine Matched Env: 1086C_D7gp120.avi/293F, dilution 1:100 Number Analyzed 114 participants
22000
(22000 to 22000)
Vaccine Matched Env: 96ZM651.D11gp120.avi, dilution 1: 50 Number Analyzed 113 participants
22000
(22000 to 22000)
Vaccine Matched Env: 96ZM651.D11gp120.avi, dilution 1:100 Number Analyzed 113 participants
19310.5
(12406.2 to 22000)
Vaccine Matched Env: TV1c8_D11gp120.avi/293F, dilution 1: 50 Number Analyzed 114 participants
22000
(22000 to 22000)
Vaccine Matched Env: TV1c8_D11gp120.avi/293F, dilution 1:100 Number Analyzed 114 participants
22000
(22000 to 22000)
Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2, dilution 1: 50 Number Analyzed 61 participants
1319.8
(620 to 4714.8)
Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2, dilution 1:100 Number Analyzed 61 participants
538.5
(283.8 to 1248.8)
Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F, dilution 1: 50 Number Analyzed 73 participants
1452.8
(530.2 to 5018.2)
Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F, dilution 1:100 Number Analyzed 73 participants
640.2
(259.5 to 1809.5)
Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F, dilution 1: 50 Number Analyzed 103 participants
4573.2
(1793.4 to 14216.1)
Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F, dilution 1:100 Number Analyzed 103 participants
2029.2
(688.2 to 6273.9)
gp41, dilution 1: 50 Number Analyzed 1 participants
2125
(2125 to 2125)
gp41, dilution 1:100 Number Analyzed 1 participants
780.8
(780.8 to 780.8)
23.Secondary Outcome
Title Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5
Hide Description Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 120
Median (Inter-Quartile Range)
Unit of Measure: net mean fluorescent intensity (net MFI)
HVTN 505 Env Breadth Panel: A1.con.env03 140 CF Number Analyzed 74 participants
277.1
(171.1 to 702.7)
HVTN 505 Env Breadth Panel: B.con.env03 140 CF Number Analyzed 106 participants
369.5
(217.2 to 974.2)
HVTN 505 Env Breadth Panel: C.con.env03 140 CF_avi Number Analyzed 87 participants
302.2
(154.2 to 601.5)
HVTN 505 Env Breadth Panel: Con 6 gp120/B Number Analyzed 99 participants
318.5
(181.5 to 775.5)
HVTN 505 Env Breadth Panel: Con S gp140 CFI Number Analyzed 115 participants
843
(471.9 to 2435)
HVTN 505 Env Breadth Panel: VRC A_avi Number Analyzed 72 participants
337.8
(160.2 to 844.6)
HVTN 505 Env Breadth Panel: VRC B gp140 Number Analyzed 42 participants
208.2
(140.9 to 432.4)
HVTN 505 Env Breadth Panel: VRC C_avi Number Analyzed 68 participants
262.9
(135.2 to 540.8)
RV144 CoR IgG3: C.1086C_V1_V2 Tags Number Analyzed 32 participants
277.5
(131.2 to 601.6)
RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K Number Analyzed 9 participants
963.5
(213.8 to 3295.5)
RV144 CoR IgG3: gp70_B.CaseA_V1_V2 Number Analyzed 8 participants
1598.9
(316.9 to 3041.8)
V1V2 Subtype AW: AE.A244 V1V2 Tags/293F Number Analyzed 49 participants
350.8
(237 to 868.8)
Vaccine Matched Env: 1086C_D7gp120.avi/293F Number Analyzed 120 participants
4534.8
(2132.6 to 11252.6)
Vaccine Matched Env: 96ZM651.D11gp120.avi Number Analyzed 110 participants
700.5
(333.9 to 1815.9)
Vaccine Matched Env: TV1c8_D11gp120.avi/293F Number Analyzed 118 participants
2059.5
(896.6 to 5165.4)
Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2 Number Analyzed 10 participants
1398.2
(370.2 to 3796.9)
Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F Number Analyzed 12 participants
511.4
(222.6 to 1469.4)
Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F Number Analyzed 54 participants
572.6
(379.7 to 1367.2)
24.Secondary Outcome
Title Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5
Hide Description Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
Time Frame Measured at Month 6.5
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.
Arm/Group Title Vaccine
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 120
Median (Inter-Quartile Range)
Unit of Measure: net mean fluorescent intensity (net MFI)
RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140 Number Analyzed 60 participants
1521.5
(657.8 to 3967.9)
RV144 CoR IgA Primary gp120 Score: 92TH023 gp120 gDneg 293F mon Number Analyzed 48 participants
1024.8
(666.6 to 1453.9)
RV144 CoR IgA Primary gp120 Score: A1.con.env03 140 CF Number Analyzed 72 participants
2511.9
(949.1 to 5347)
RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon Number Analyzed 34 participants
801.2
(506.3 to 1325.8)
RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF Number Analyzed 83 participants
3140.2
(1685 to 6907.4)
RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi Number Analyzed 75 participants
2149.8
(1102.6 to 4907)
RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B Number Analyzed 68 participants
2877.9
(1620.6 to 5074.7)
RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI Number Analyzed 95 participants
5239.2
(2974.8 to 11492.1)
RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF Number Analyzed 73 participants
2845
(1261 to 6844.8)
RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF Number Analyzed 41 participants
791
(483.8 to 1970.2)
RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140 Number Analyzed 65 participants
1291.5
(588.2 to 3242)
Vaccine Matched Env: 1086C_D7gp120.avi/293F Number Analyzed 114 participants
22000
(21620.4 to 22000)
Vaccine Matched Env: 96ZM651.D11gp120.avi Number Analyzed 82 participants
6673.8
(4418.9 to 10935.2)
Vaccine Matched Env: TV1c8_D11gp120.avi/293F Number Analyzed 90 participants
6205
(3399 to 9946.1)
gp70-96ZM651.02 V1v2 Number Analyzed 1 participants
22000
(22000 to 22000)
gp70-TV1.GSKvacV1V2/293F Number Analyzed 4 participants
1059.5
(731.9 to 3515.9)
gp70_C.1086C V1/V2/293F Number Analyzed 13 participants
5786.5
(5169 to 8446)
25.Secondary Outcome
Title Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants
Hide Description Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
Time Frame Measured through 24 months after first vaccination
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Females in MITT cohort
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
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ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 1887 1886
Measure Type: Number
Unit of Measure: events per 100 person-years
0.043 0.042
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Log Rank
Comments The hazard ratio was tested using a sex-stratified log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.80 to 1.33
Estimation Comments The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.
26.Secondary Outcome
Title Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants
Hide Description Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
Time Frame Measured through 24 months after first vaccination
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Hide Analysis Population Description
Males in MITT cohort
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 808 803
Measure Type: Number
Unit of Measure: events per 100 person-years
0.013 0.013
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Log Rank
Comments The hazard ratio was tested using a sex-stratified log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.50 to 1.98
Estimation Comments The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.
27.Secondary Outcome
Title Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger
Hide Description Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
Time Frame Measured through 24 months after first vaccination
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Hide Analysis Population Description
Females in MITT cohort aged 25 or younger
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 1264 1267
Measure Type: Number
Unit of Measure: events per 100 person-years
0.047 0.044
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Log Rank
Comments The hazard ratio was tested using a sex-stratified log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.80 to 1.47
Estimation Comments The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.
28.Secondary Outcome
Title Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25
Hide Description Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
Time Frame Measured through 24 months after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Females in MITT cohort older than 25
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
Hide Arm/Group Description:
ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
Overall Number of Participants Analyzed 623 619
Measure Type: Number
Unit of Measure: events per 100 person-years
0.035 0.039
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALVAC-HIV + Subtype C gp120/MF59, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Log Rank
Comments The hazard ratio was tested using a sex-stratified log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.58 to 1.46
Estimation Comments The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.
29.Secondary Outcome
Title Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through Month 24 by Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such As Signature Site Mutations
Hide Description Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.
Time Frame Measured through 24 months after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.
Arm/Group Title ALVAC-HIV + Subtype C gp120/MF59 Placebo
Hide Arm/Group Description:
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, 12, and 18 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5 mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, 12, and 18
Placebo for ALVAC-HIV (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, 12, and 18 AND Placebo for Bivalent Subtype C gp120/MF59 (Sodium Chloride for Injection, 0.9%) administered as 0.5 mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, 12, and 18
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis
Hide Description The sieve analysis will be conducted using updates of the methods that were used for the Step (Rolland et al., 2011) and RV144 HIV vaccine efficacy trials.
Time Frame Measured at the earliest post-infection time-point
Outcome Measure Data Not Reported
Time Frame Serious adverse events, adverse events of special interest, adverse events of STIs, new chronic medical conditions, and adverse events leading to early participant withdrawal or early discontinuation of study product(s) administration were collected through 12 months after the last vaccination received. All other adverse events were collected through 30 days after each vaccination.
Adverse Event Reporting Description Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
 
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18 Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
All-Cause Mortality
Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/2704 (0.30%)      10/2700 (0.37%)    
Hide Serious Adverse Events
Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   103/2704 (3.81%)      95/2700 (3.52%)    
Blood and lymphatic system disorders     
Any Event in SOC * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Anaemia * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Anaemia of pregnancy * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Cardiac disorders     
Any Event in SOC * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Cardiac arrest * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Palpitations * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Ear and labyrinth disorders     
Any Event in SOC * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Tympanic membrane perforation * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Endocrine disorders     
Any Event in SOC * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Goitre * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Gastrointestinal disorders     
Any Event in SOC * 1  3/2704 (0.11%)  3 4/2700 (0.15%)  5
Abdominal pain upper * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Alcoholic pancreatitis * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Ascites * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Constipation * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Diarrhoea * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Obstructive pancreatitis * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Pancreatic pseudocyst * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Proctalgia * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
General disorders     
Any Event in SOC * 1  4/2704 (0.15%)  4 1/2700 (0.04%)  1
Chest pain * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Electrocution * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Mass * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Peripheral swelling * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Sudden death * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Hepatobiliary disorders     
Any Event in SOC * 1  4/2704 (0.15%)  6 0/2700 (0.00%)  0
Bile duct stone * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Cholecystitis * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Cholelithiasis * 1  2/2704 (0.07%)  2 0/2700 (0.00%)  0
Drug-induced liver injury * 1  1/2704 (0.04%)  2 0/2700 (0.00%)  0
Infections and infestations     
Any Event in SOC * 1  15/2704 (0.55%)  16 17/2700 (0.63%)  20
Abscess limb * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Acute hepatitis B * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Appendiceal abscess * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Appendicitis * 1  1/2704 (0.04%)  1 2/2700 (0.07%)  2
Arthritis bacterial * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Cellulitis * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Central nervous system infection * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  2
Gastroenteritis * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Genital abscess * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Meningitis * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Meningitis bacterial * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  2
Meningitis tuberculous * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Paronychia * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Pelvic inflammatory disease * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Pneumonia * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Pulmonary tuberculosis * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Pyelonephritis * 1  3/2704 (0.11%)  3 0/2700 (0.00%)  0
Pyelonephritis acute * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Tooth abscess * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Tuberculosis * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Injury, poisoning and procedural complications     
Any Event in SOC * 1  42/2704 (1.55%)  44 38/2700 (1.41%)  40
Abdominal injury * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Accidental overdose * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Ankle fracture * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Back injury * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Burns second degree * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Chemical poisoning * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Chest injury * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Clavicle fracture * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Craniocerebral injury * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Eye injury * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Face injury * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Femur fracture * 1  2/2704 (0.07%)  2 0/2700 (0.00%)  0
Fibula fracture * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Gun shot wound * 1  5/2704 (0.18%)  5 2/2700 (0.07%)  2
Hand fracture * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Head injury * 1  3/2704 (0.11%)  3 2/2700 (0.07%)  2
Humerus fracture * 1  1/2704 (0.04%)  1 2/2700 (0.07%)  2
Injury * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Joint dislocation * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Limb injury * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Limb traumatic amputation * 1  2/2704 (0.07%)  2 0/2700 (0.00%)  0
Multiple injuries * 1  2/2704 (0.07%)  2 2/2700 (0.07%)  2
Peripancreatic fluid collection * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Radius fracture * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Skin laceration * 1  2/2704 (0.07%)  2 2/2700 (0.07%)  2
Skull fracture * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Snake bite * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Soft tissue injury * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Stab wound * 1  7/2704 (0.26%)  7 7/2700 (0.26%)  7
Tendon injury * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Thermal burn * 1  2/2704 (0.07%)  2 0/2700 (0.00%)  0
Tibia fracture * 1  1/2704 (0.04%)  1 2/2700 (0.07%)  2
Toxicity to various agents * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Traumatic haemothorax * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Ulna fracture * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Upper limb fracture * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Wrist fracture * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Investigations     
Any Event in SOC * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Haemoglobin decreased * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Metabolism and nutrition disorders     
Any Event in SOC * 1  2/2704 (0.07%)  4 0/2700 (0.00%)  0
Diabetes mellitus inadequate control * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Hypoglycaemia * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Type 2 diabetes mellitus * 1  2/2704 (0.07%)  2 0/2700 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Any Event in SOC * 1  5/2704 (0.18%)  5 1/2700 (0.04%)  1
Back pain * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Mixed connective tissue disease * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Muscle spasms * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Myalgia * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Systemic lupus erythematosus * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Any Event in SOC * 1  0/2704 (0.00%)  0 3/2700 (0.11%)  3
Anogenital warts * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Breast cancer * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Uterine leiomyoma * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Nervous system disorders     
Any Event in SOC * 1  5/2704 (0.18%)  5 0/2700 (0.00%)  0
Epilepsy * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Headache * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Migraine * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Status epilepticus * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Syncope * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Any Event in SOC * 1  9/2704 (0.33%)  9 12/2700 (0.44%)  12
Abortion incomplete * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Abortion spontaneous * 1  2/2704 (0.07%)  2 4/2700 (0.15%)  4
Breech presentation * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Ectopic pregnancy * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Gestational hypertension * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Pre-eclampsia * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Premature baby * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Premature delivery * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Premature labour * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Premature separation of placenta * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Stillbirth * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Psychiatric disorders     
Any Event in SOC * 1  11/2704 (0.41%)  11 12/2700 (0.44%)  12
Acute psychosis * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Acute stress disorder * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Anxiety * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Bipolar disorder * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Completed suicide * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Intentional self-injury * 1  1/2704 (0.04%)  1 3/2700 (0.11%)  3
Panic attack * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Psychotic disorder * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Schizoaffective disorder bipolar type * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Stress * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Substance-induced psychotic disorder * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Suicidal ideation * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Suicide attempt * 1  4/2704 (0.15%)  4 1/2700 (0.04%)  1
Renal and urinary disorders     
Any Event in SOC * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Acute kidney injury * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Reproductive system and breast disorders     
Any Event in SOC * 1  1/2704 (0.04%)  1 2/2700 (0.07%)  2
Dysfunctional uterine bleeding * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Female reproductive tract disorder * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Testicular torsion * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Respiratory, thoracic and mediastinal disorders     
Any Event in SOC * 1  4/2704 (0.15%)  4 3/2700 (0.11%)  3
Asthma * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Haemothorax * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Pneumonia aspiration * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Pneumothorax * 1  2/2704 (0.07%)  2 0/2700 (0.00%)  0
Pneumothorax spontaneous * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Pulmonary embolism * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Skin and subcutaneous tissue disorders     
Any Event in SOC * 1  1/2704 (0.04%)  2 1/2700 (0.04%)  1
Dermatitis allergic * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Rash * 1  1/2704 (0.04%)  2 0/2700 (0.00%)  0
Vascular disorders     
Any Event in SOC * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Hypertensive urgency * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
1
Term from vocabulary, MEDRA 24.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1707/2704 (63.13%)      1704/2700 (63.11%)    
Blood and lymphatic system disorders     
Any Event in SOC * 1  11/2704 (0.41%)  12 11/2700 (0.41%)  12
Anaemia * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Iron deficiency anaemia * 1  9/2704 (0.33%)  9 5/2700 (0.19%)  5
Lymphadenitis * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Lymphadenopathy * 1  1/2704 (0.04%)  1 5/2700 (0.19%)  5
Neutropenia * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Cardiac disorders     
Any Event in SOC * 1  3/2704 (0.11%)  3 1/2700 (0.04%)  1
Bradycardia * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Palpitations * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Sinus bradycardia * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Ear and labyrinth disorders     
Any Event in SOC * 1  10/2704 (0.37%)  10 3/2700 (0.11%)  3
Cerumen impaction * 1  3/2704 (0.11%)  3 2/2700 (0.07%)  2
Ear discomfort * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Ear pain * 1  6/2704 (0.22%)  6 0/2700 (0.00%)  0
Vertigo * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Endocrine disorders     
Any Event in SOC * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Basedow's disease * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Eye disorders     
Any Event in SOC * 1  17/2704 (0.63%)  18 16/2700 (0.59%)  16
Atopic keratoconjunctivitis * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Chalazion * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Conjunctival haemorrhage * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Conjunctivitis allergic * 1  5/2704 (0.18%)  5 9/2700 (0.33%)  9
Eye irritation * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Eye pain * 1  4/2704 (0.15%)  4 0/2700 (0.00%)  0
Eye pruritus * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Eye swelling * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Ocular hyperaemia * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Periorbital pain * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Periorbital swelling * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Photokeratitis * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Swelling of eyelid * 1  2/2704 (0.07%)  2 0/2700 (0.00%)  0
Visual acuity reduced * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Gastrointestinal disorders     
Any Event in SOC * 1  151/2704 (5.58%)  165 162/2700 (6.00%)  178
Abdominal distension * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Abdominal pain * 1  22/2704 (0.81%)  22 18/2700 (0.67%)  18
Abdominal pain lower * 1  10/2704 (0.37%)  10 15/2700 (0.56%)  15
Abdominal pain upper * 1  6/2704 (0.22%)  6 5/2700 (0.19%)  5
Anal pruritus * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Angular cheilitis * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Aphthous ulcer * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Breath odour * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Constipation * 1  8/2704 (0.30%)  8 3/2700 (0.11%)  3
Dental caries * 1  7/2704 (0.26%)  7 9/2700 (0.33%)  9
Diarrhoea * 1  29/2704 (1.07%)  29 41/2700 (1.52%)  44
Dyspepsia * 1  7/2704 (0.26%)  7 10/2700 (0.37%)  10
Faeces discoloured * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Flatulence * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Gastritis * 1  15/2704 (0.55%)  15 11/2700 (0.41%)  12
Gastrointestinal disorder * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Gastrointestinal haemorrhage * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Gastrooesophageal reflux disease * 1  5/2704 (0.18%)  5 5/2700 (0.19%)  6
Gingival pain * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Haematemesis * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Haemorrhoidal haemorrhage * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Haemorrhoids * 1  4/2704 (0.15%)  4 9/2700 (0.33%)  9
Inguinal hernia * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Lip swelling * 1  1/2704 (0.04%)  1 2/2700 (0.07%)  3
Mouth cyst * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Mouth ulceration * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Nausea * 1  8/2704 (0.30%)  8 11/2700 (0.41%)  11
Peptic ulcer * 1  3/2704 (0.11%)  3 0/2700 (0.00%)  0
Proctalgia * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Proctitis * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Rectal ulcer * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Stomatitis * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Tooth impacted * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Toothache * 1  17/2704 (0.63%)  17 10/2700 (0.37%)  10
Vomiting * 1  8/2704 (0.30%)  8 11/2700 (0.41%)  11
General disorders     
Any Event in SOC * 1  206/2704 (7.62%)  233 198/2700 (7.33%)  218
Adverse drug reaction * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Axillary pain * 1  2/2704 (0.07%)  4 0/2700 (0.00%)  0
Chest pain * 1  2/2704 (0.07%)  2 0/2700 (0.00%)  0
Chills * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Fatigue * 1  6/2704 (0.22%)  6 9/2700 (0.33%)  9
Hangover * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Hernia * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Influenza like illness * 1  166/2704 (6.14%)  181 171/2700 (6.33%)  188
Injection site bruising * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Injection site dermatitis * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Injection site discolouration * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Injection site erythema * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Injection site pain * 1  0/2704 (0.00%)  0 3/2700 (0.11%)  3
Injection site pruritus * 1  21/2704 (0.78%)  23 2/2700 (0.07%)  2
Injection site reaction * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Injection site swelling * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Injection site ulcer * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Malaise * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Mass * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Non-cardiac chest pain * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Oedema peripheral * 1  0/2704 (0.00%)  0 2/2700 (0.07%)  2
Pain * 1  0/2704 (0.00%)  0 3/2700 (0.11%)  3
Peripheral swelling * 1  2/2704 (0.07%)  2 1/2700 (0.04%)  1
Pyrexia * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Swelling face * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Vessel puncture site pain * 1  0/2704 (0.00%)  0 1/2700 (0.04%)  1
Hepatobiliary disorders     
Any Event in SOC * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Cholelithiasis * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Immune system disorders     
Any Event in SOC * 1  4/2704 (0.15%)  4 3/2700 (0.11%)  3
Anti-neutrophil cytoplasmic antibody positive vasculitis * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Drug hypersensitivity * 1  1/2704 (0.04%)  1 0/2700 (0.00%)  0
Food allergy * 1  1/2704 (0.04%)  1 1/2700 (0.04%)  1
Hypersensitivity * 1  1/2704 (0.04%)  1 2/2700 (0.07%)  2
Infections and infestations     
Any Event in SOC * 1