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Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men

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ClinicalTrials.gov Identifier: NCT00865566
Recruitment Status : Terminated (The trial was stopped for efficacy futility)
First Posted : March 19, 2009
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
HIV Vaccine Trials Network
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: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Biological: DNA plasmid vaccine
Biological: Recombinant adenoviral serotype 5 (rAD5) vector vaccine
Biological: DNA vaccine placebo
Biological: HIV-1 recombinant adenovirus vaccine placebo
Enrollment 2504
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Period Title: Overall Study
Started [1] 1253 1251
Modified Intent-to-Treat Population [2] 1251 1245
Completed [3] 629 564
Not Completed 624 687
Reason Not Completed
Death             1             11
Lost to Follow-up             314             315
Withdrawal by Subject             45             65
Physician Decision             0             1
Participant relocated             78             107
Participant unable to adhere             27             42
Other; N=245 due to early study closure             154             139
HIV infection             5             7
[1]
Enrollment is defined as receiving the first vaccination.
[2]
Participants excluded from MITT if HIV-1 positive at first vaccination (retrospective testing)
[3]
Completed if attended all visits. Note dropout endpoint does NOT include all visits.
Arm/Group Title Vaccine Placebo Total
Hide Arm/Group Description

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Total of all reporting groups
Overall Number of Baseline Participants 1253 1251 2504
Hide Baseline Analysis Population Description
All Enrolled Participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1253 participants 1251 participants 2504 participants
29
(18 to 50)
30
(18 to 50)
29
(18 to 50)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants 1251 participants 2504 participants
18-20 years
105
   8.4%
108
   8.6%
213
   8.5%
21-30 years
585
  46.7%
569
  45.5%
1154
  46.1%
31-40 years
299
  23.9%
299
  23.9%
598
  23.9%
41-50 years
264
  21.1%
275
  22.0%
539
  21.5%
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants 1251 participants 2504 participants
Male
1231
  98.2%
1229
  98.2%
2460
  98.2%
Female
4
   0.3%
4
   0.3%
8
   0.3%
Transgender Male
1
   0.1%
1
   0.1%
2
   0.1%
Transgender Female
13
   1.0%
15
   1.2%
28
   1.1%
Other
4
   0.3%
2
   0.2%
6
   0.2%
[1]
Measure Description: Self-reported gender identity
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants 1251 participants 2504 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1253
 100.0%
1251
 100.0%
2504
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants 1251 participants 2504 participants
Hispanic or Latino
125
  10.0%
94
   7.5%
219
   8.7%
Not Hispanic or Latino
1128
  90.0%
1157
  92.5%
2285
  91.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants 1251 participants 2504 participants
American Indian or Alaska Native
3
   0.2%
10
   0.8%
13
   0.5%
Asian
13
   1.0%
20
   1.6%
33
   1.3%
Native Hawaiian or Other Pacific Islander
4
   0.3%
6
   0.5%
10
   0.4%
Black or African American
222
  17.7%
204
  16.3%
426
  17.0%
White
939
  74.9%
944
  75.5%
1883
  75.2%
More than one race
45
   3.6%
46
   3.7%
91
   3.6%
Unknown or Not Reported
27
   2.2%
21
   1.7%
48
   1.9%
Body Mass Index (BMI)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants 1251 participants 2504 participants
<18.5 kg/m^2
22
   1.8%
16
   1.3%
38
   1.5%
18.5-24.9 kg/m^2
550
  43.9%
586
  46.8%
1136
  45.4%
25.0-29.9 kg/m^2
391
  31.2%
381
  30.5%
772
  30.8%
30.0-34.9 kg/m^2
189
  15.1%
167
  13.3%
356
  14.2%
35-39.9 kg/m^2
64
   5.1%
59
   4.7%
123
   4.9%
>=40 kg/m^2
36
   2.9%
41
   3.3%
77
   3.1%
Missing/Unknown
1
   0.1%
1
   0.1%
2
   0.1%
Number of male sexual partners within 3 months prior to screening assessment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants 1251 participants 2504 participants
0
59
   4.7%
64
   5.1%
123
   4.9%
1
256
  20.4%
243
  19.4%
499
  19.9%
2
253
  20.2%
242
  19.3%
495
  19.8%
3-4
349
  27.9%
367
  29.3%
716
  28.6%
5 or more
330
  26.3%
327
  26.1%
657
  26.2%
Unknown
6
   0.5%
8
   0.6%
14
   0.6%
Number of male sexual partners within 3 months prior to screening assessment   [1] 
Median (Full Range)
Unit of measure:  Partners
Number Analyzed 1253 participants 1251 participants 2504 participants
3
(0 to 125)
3
(0 to 70)
3
(0 to 125)
[1]
Measure Description: Self-reported at screening
Any unprotected receptive anal sex with a partner within 3 months prior to screening assessment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants 1251 participants 2504 participants
589
  47.0%
573
  45.8%
1162
  46.4%
[1]
Measure Description: Self-reported at screening
1.Primary Outcome
Title Participant Dropout Through Month 48
Hide Description For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
Time Frame Enrollment through Month 48 visit
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Overall Number of Participants Analyzed 1251 1245
Measure Type: Count of Participants
Unit of Measure: Participants
340
  27.2%
436
  35.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaccine, Placebo
Comments Cox proportional hazards model to assess the association between treatment assignment and dropout
Type of Statistical Test Other
Comments Score test
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.63 to 0.84
Estimation Comments HR is vaccine / placebo
2.Primary Outcome
Title Participant Dropout Prior to Unblinding
Hide Description

The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.

For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.

Time Frame Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Overall Number of Participants Analyzed 1251 1245
Measure Type: Count of Participants
Unit of Measure: Participants
99
   7.9%
127
  10.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaccine, Placebo
Comments Cox PH model to assess the association between treatment assignment and dropout
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments Score test
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.59 to 1
Estimation Comments HR is vaccine / placebo
3.Primary Outcome
Title Participant Dropout After Unblinding
Hide Description

The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.

For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.

Time Frame April 23, 2013 through trial closure (up to Month 48 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population participants who were HIV-uninfected and on-study as of April 23, 2013
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Overall Number of Participants Analyzed 1036 999
Measure Type: Count of Participants
Unit of Measure: Participants
241
  23.3%
309
  30.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaccine, Placebo
Comments Assess the association between treatment assignment and dropout
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Score test
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.60 to 0.84
Estimation Comments HR is vaccine / placebo
4.Primary Outcome
Title HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit
Hide Description For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.
Time Frame Enrollment through Month 48 visit
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Overall Number of Participants Analyzed 1251 1245
Measure Type: Number
Unit of Measure: participants
75 68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaccine, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.903
Comments Score test
Method Regression, Cox
Comments Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.73 to 1.42
Estimation Comments HR is vaccine / placebo
5.Primary Outcome
Title HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit
Hide Description For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit.
Time Frame Enrollment through Month 24 visit
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Cohort
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Overall Number of Participants Analyzed 1251 1245
Measure Type: Number
Unit of Measure: participants
49 46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaccine, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.783
Comments Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI
Method Regression, Cox
Comments Score test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.71 to 1.58
Estimation Comments HR is vaccine / placebo
6.Primary Outcome
Title Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness
Hide Description For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.
Time Frame Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All Enrolled Participants
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Overall Number of Participants Analyzed 1253 1251
Measure Type: Count of Participants
Unit of Measure: Participants
None
138
  11.0%
415
  33.2%
Mild
723
  57.7%
744
  59.5%
Moderate
370
  29.5%
90
   7.2%
Severe
22
   1.8%
2
   0.2%
Potentially life-threatening
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration
Hide Description For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.
Time Frame Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Overall Number of Participants Analyzed 1253 1251
Measure Type: Count of Participants
Unit of Measure: Participants
None
717
  57.2%
980
  78.3%
>0 to 25 square cm
498
  39.7%
268
  21.4%
>25 to 81 square cm (grade 1)
15
   1.2%
2
   0.2%
>9 cm any diameter (grade 2)
6
   0.5%
0
   0.0%
>81 square cm (grade 2)
17
   1.4%
1
   0.1%
8.Primary Outcome
Title Number of Participants Experiencing Systemic Reactogenicity
Hide Description For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters.
Time Frame Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:

Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Overall Number of Participants Analyzed 1253 1251
Measure Type: Count of Participants
Unit of Measure: Participants
None
563
  44.9%
667
  53.3%
Mild
408
  32.6%
406
  32.5%
Moderate
240
  19.2%
169
  13.5%
Severe
42
   3.4%
9
   0.7%
Potentially life-threatening
0
   0.0%
0
   0.0%
Time Frame Reporting of all AEs occurred during 2 periods for each participant: 1) from enrollment through 28 days after the third vaccination, and 2) from the fourth vaccination through 28 days after the fourth vaccination. Between and after these time periods, only SAEs, new chronic conditions requiring medical intervention of more than 30 days, and newly diagnosed/treated STIs were reported. Events requiring expedited reporting (protocol section 12.3) were reported through the study, up to 60 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vaccine Placebo
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Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.

DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid

HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

All-Cause Mortality
Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1253 (0.08%)   11/1251 (0.88%) 
Show Serious Adverse Events Hide Serious Adverse Events
Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   77/1253 (6.15%)   95/1251 (7.59%) 
Blood and lymphatic system disorders     
Any event in SOC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Anaemias NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Cardiac disorders     
Any event in SOC * 1  1/1253 (0.08%)  6/1251 (0.48%) 
Ischaemic coronary artery disorders * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Coronary artery disorders NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Heart failures NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Supraventricular arrhythmias * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Ventricular arrhythmias and cardiac arrest * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Congenital, familial and genetic disorders     
Any event in SOC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Haemoglobinopathies congenital * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Gastrointestinal disorders     
Any event in SOC * 1  2/1253 (0.16%)  15/1251 (1.20%) 
Colitis (excl infective) * 1  1/1253 (0.08%)  3/1251 (0.24%) 
Acute and chronic pancreatitis * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Duodenal ulcers and perforation * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Intestinal ulcers and perforation NEC * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Abdominal hernias NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Gastric ulcers and perforation * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Gastrointestinal atonic and hypomotility disorders NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Gastrointestinal disorders NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Gastrointestinal stenosis and obstruction NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Non-site specific gastrointestinal haemorrhages * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Oesophageal ulcers and perforation * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Rectal inflammations NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
General disorders     
Any event in SOC * 1  2/1253 (0.16%)  5/1251 (0.40%) 
Pain and discomfort NEC * 1  1/1253 (0.08%)  3/1251 (0.24%) 
Death and sudden death * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Withdrawal and rebound effects * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Immune system disorders     
Any event in SOC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Acute and chronic sarcoidosis * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Allergies to foods, food additives, drugs and other chemicals * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Infections and infestations     
Any event in SOC * 1  25/1253 (2.00%)  26/1251 (2.08%) 
Abdominal and gastrointestinal infections * 1  8/1253 (0.64%)  11/1251 (0.88%) 
Bacterial infections NEC * 1  5/1253 (0.40%)  4/1251 (0.32%) 
Infections NEC * 1  2/1253 (0.16%)  3/1251 (0.24%) 
Lower respiratory tract and lung infections * 1  3/1253 (0.24%)  1/1251 (0.08%) 
Upper respiratory tract infections * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Clostridia infections * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Sepsis, bacteraemia, viraemia and fungaemia NEC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Skin structures and soft tissue infections * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Staphylococcal infections * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Streptococcal infections * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Bone and joint infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Borrelial infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Breast infections * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Herpes viral infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Infectious disorders carrier * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Urinary tract infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Viral infections NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Injury, poisoning and procedural complications     
Any event in SOC * 1  15/1253 (1.20%)  15/1251 (1.20%) 
Limb fractures and dislocations * 1  4/1253 (0.32%)  2/1251 (0.16%) 
Skull fractures, facial bone fractures and dislocations * 1  2/1253 (0.16%)  3/1251 (0.24%) 
Non-site specific injuries NEC * 1  2/1253 (0.16%)  2/1251 (0.16%) 
Overdoses NEC * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Poisoning and toxicity * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Site specific injuries NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Skin injuries NEC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Spinal fractures and dislocations * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Abdominal injuries NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Cardiac and vascular procedural complications * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Cardiovascular injuries * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Cerebral injuries NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Muscle, tendon and ligament injuries * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Pathways and sources of exposure * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Thermal burns * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Investigations     
Any event in SOC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Liver function analyses * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Metabolism tests NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Metabolism and nutrition disorders     
Any event in SOC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Potassium imbalance * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Musculoskeletal and connective tissue disorders     
Any event in SOC * 1  1/1253 (0.08%)  3/1251 (0.24%) 
Bursal disorders * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Intervertebral disc disorders NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Muscle weakness conditions * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Myopathies * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Any event in SOC * 1  4/1253 (0.32%)  3/1251 (0.24%) 
Prostatic neoplasms malignant * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Colorectal neoplasms malignant * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Gastric neoplasms malignant * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Leukaemias acute lymphocytic * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Testicular neoplasms malignant * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Thyroid neoplasms malignant * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Nervous system disorders     
Any event in SOC * 1  7/1253 (0.56%)  2/1251 (0.16%) 
Seizures and seizure disorders NEC * 1  3/1253 (0.24%)  0/1251 (0.00%) 
Central nervous system haemorrhages and cerebrovascular accidents * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Encephalopathies NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Mononeuropathies * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Neurological signs and symptoms NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Optic nerve disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Transient cerebrovascular events * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Product Issues     
Any event in SOC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Device malfunction events NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Psychiatric disorders     
Any event in SOC * 1  23/1253 (1.84%)  22/1251 (1.76%) 
Suicidal and self-injurious behaviour * 1  13/1253 (1.04%)  11/1251 (0.88%) 
Depressive disorders * 1  4/1253 (0.32%)  3/1251 (0.24%) 
Substance related and addictive disorders * 1  5/1253 (0.40%)  2/1251 (0.16%) 
Bipolar disorders * 1  0/1253 (0.00%)  3/1251 (0.24%) 
Anxiety symptoms * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Psychotic disorder NEC * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Confusion and disorientation * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Mental disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Schizoaffective and schizophreniform disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Schizophrenia NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Somatic symptom disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Renal and urinary disorders     
Any event in SOC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Renal failure and impairment * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Renal lithiasis * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Reproductive system and breast disorders     
Any event in SOC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Testicular and epididymal disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Any event in SOC * 1  3/1253 (0.24%)  2/1251 (0.16%) 
Pulmonary thrombotic and embolic conditions * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Pneumothorax and pleural effusions NEC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Skin and subcutaneous tissue disorders     
Any event in SOC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Skin and subcutaneous tissue ulcerations * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Vascular disorders     
Any event in SOC * 1  4/1253 (0.32%)  1/1251 (0.08%) 
Peripheral embolism and thrombosis * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Non-site specific necrosis and vascular insufficiency NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Vascular hypertensive disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Vascular hypotensive disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   833/1253 (66.48%)   828/1251 (66.19%) 
Blood and lymphatic system disorders     
Any event in SOC * 1  22/1253 (1.76%)  17/1251 (1.36%) 
Lymphatic system disorders NEC * 1  20/1253 (1.60%)  15/1251 (1.20%) 
Anaemias NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Leukocytoses NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Red blood cell abnormal findings NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Spleen disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Cardiac disorders     
Any event in SOC * 1  2/1253 (0.16%)  5/1251 (0.40%) 
Supraventricular arrhythmias * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Cardiac signs and symptoms NEC * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Rate and rhythm disorders NEC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Congenital, familial and genetic disorders     
Any event in SOC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Male reproductive tract disorders congenital * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Ear and labyrinth disorders     
Any event in SOC * 1  10/1253 (0.80%)  7/1251 (0.56%) 
Ear disorders NEC * 1  3/1253 (0.24%)  5/1251 (0.40%) 
Inner ear signs and symptoms * 1  3/1253 (0.24%)  1/1251 (0.08%) 
External ear disorders NEC * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Middle ear disorders NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Eustachian tube disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Hearing losses * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Tympanic membrane disorders (excl infections) * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Endocrine disorders     
Any event in SOC * 1  8/1253 (0.64%)  2/1251 (0.16%) 
Thyroid hypofunction disorders * 1  4/1253 (0.32%)  2/1251 (0.16%) 
Endocrine abnormalities of gonadal function NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Male gonadal function disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Thyroid hyperfunction disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Eye disorders     
Any event in SOC * 1  17/1253 (1.36%)  11/1251 (0.88%) 
Lid, lash and lacrimal infections, irritations and inflammations * 1  4/1253 (0.32%)  1/1251 (0.08%) 
Ocular disorders NEC * 1  2/1253 (0.16%)  2/1251 (0.16%) 
Conjunctival and corneal bleeding and vascular disorders * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Ocular sensation disorders * 1  0/1253 (0.00%)  3/1251 (0.24%) 
Visual disorders NEC * 1  3/1253 (0.24%)  0/1251 (0.00%) 
Conjunctival infections, irritations and inflammations * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Eyelid movement disorders * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Lacrimation disorders * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Ocular infections, inflammations and associated manifestations * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Blindness (excl colour blindness) * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Glaucomas (excl congenital) * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Refractive and accommodative disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Retinal, choroid and vitreous infections and inflammations * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Gastrointestinal disorders     
Any event in SOC * 1  149/1253 (11.89%)  146/1251 (11.67%) 
Diarrhoea (excl infective) * 1  53/1253 (4.23%)  53/1251 (4.24%) 
Nausea and vomiting symptoms * 1  28/1253 (2.23%)  21/1251 (1.68%) 
Gastrointestinal and abdominal pains (excl oral and throat) * 1  22/1253 (1.76%)  13/1251 (1.04%) 
Stomatitis and ulceration * 1  11/1253 (0.88%)  6/1251 (0.48%) 
Gastrointestinal atonic and hypomotility disorders NEC * 1  6/1253 (0.48%)  9/1251 (0.72%) 
Haemorrhoids and gastrointestinal varices (excl oesophageal) * 1  5/1253 (0.40%)  9/1251 (0.72%) 
Anal and rectal disorders NEC * 1  5/1253 (0.40%)  8/1251 (0.64%) 
Gastrointestinal signs and symptoms NEC * 1  7/1253 (0.56%)  6/1251 (0.48%) 
Gastrointestinal disorders NEC * 1  7/1253 (0.56%)  4/1251 (0.32%) 
Dental pain and sensation disorders * 1  6/1253 (0.48%)  4/1251 (0.32%) 
Dyspeptic signs and symptoms * 1  1/1253 (0.08%)  6/1251 (0.48%) 
Intestinal haemorrhages * 1  2/1253 (0.16%)  5/1251 (0.40%) 
Gastritis (excl infective) * 1  3/1253 (0.24%)  3/1251 (0.24%) 
Colitis (excl infective) * 1  0/1253 (0.00%)  4/1251 (0.32%) 
Non-site specific gastrointestinal haemorrhages * 1  2/1253 (0.16%)  2/1251 (0.16%) 
Abdominal hernias NEC * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Anal and rectal signs and symptoms * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Dental and periodontal infections and inflammations * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Diaphragmatic hernias * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Flatulence, bloating and distension * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Gingival disorders NEC * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Gingival haemorrhages * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Oesophageal ulcers and perforation * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Tongue disorders * 1  3/1253 (0.24%)  0/1251 (0.00%) 
Tongue signs and symptoms * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Benign neoplasms gastrointestinal (excl oral cavity) * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Gastrointestinal inflammatory disorders NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Oral dryness and saliva altered * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Abdominal findings abnormal * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Anal and rectal pains * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Dental disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Faecal abnormalities NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Gastrointestinal dyskinetic disorders * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Gastrointestinal fistulae * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Inguinal hernias * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Oral soft tissue pain and paraesthesia * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Peptic ulcers and perforation * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Rectal inflammations NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
General disorders     
Any event in SOC * 1  138/1253 (11.01%)  104/1251 (8.31%) 
Injection site reactions * 1  65/1253 (5.19%)  33/1251 (2.64%) 
Asthenic conditions * 1  41/1253 (3.27%)  27/1251 (2.16%) 
Febrile disorders * 1  17/1253 (1.36%)  15/1251 (1.20%) 
Feelings and sensations NEC * 1  10/1253 (0.80%)  9/1251 (0.72%) 
General signs and symptoms NEC * 1  6/1253 (0.48%)  10/1251 (0.80%) 
Pain and discomfort NEC * 1  6/1253 (0.48%)  5/1251 (0.40%) 
Administration site reactions NEC * 1  3/1253 (0.24%)  6/1251 (0.48%) 
Oedema NEC * 1  2/1253 (0.16%)  5/1251 (0.40%) 
Therapeutic and nontherapeutic responses * 1  2/1253 (0.16%)  4/1251 (0.32%) 
Vaccination site reactions * 1  5/1253 (0.40%)  1/1251 (0.08%) 
Mass conditions NEC * 1  0/1253 (0.00%)  3/1251 (0.24%) 
Withdrawal and rebound effects * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Inflammations * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Hepatobiliary disorders     
Any event in SOC * 1  3/1253 (0.24%)  3/1251 (0.24%) 
Hepatocellular damage and hepatitis NEC * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Cholecystitis and cholelithiasis * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Cholestasis and jaundice * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Hepatobiliary signs and symptoms * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Immune system disorders     
Any event in SOC * 1  25/1253 (2.00%)  14/1251 (1.12%) 
Atopic disorders * 1  10/1253 (0.80%)  7/1251 (0.56%) 
Allergies to foods, food additives, drugs and other chemicals * 1  9/1253 (0.72%)  5/1251 (0.40%) 
Allergic conditions NEC * 1  6/1253 (0.48%)  1/1251 (0.08%) 
Anaphylactic and anaphylactoid responses * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Infections and infestations     
Any event in SOC * 1  531/1253 (42.38%)  549/1251 (43.88%) 
Upper respiratory tract infections * 1  275/1253 (21.95%)  254/1251 (20.30%) 
Neisseria infections * 1  79/1253 (6.30%)  83/1251 (6.63%) 
Viral infections NEC * 1  75/1253 (5.99%)  72/1251 (5.76%) 
Chlamydial infections * 1  72/1253 (5.75%)  72/1251 (5.76%) 
Treponema infections * 1  32/1253 (2.55%)  41/1251 (3.28%) 
Abdominal and gastrointestinal infections * 1  37/1253 (2.95%)  29/1251 (2.32%) 
Herpes viral infections * 1  31/1253 (2.47%)  30/1251 (2.40%) 
Streptococcal infections * 1  22/1253 (1.76%)  31/1251 (2.48%) 
Urinary tract infections * 1  20/1253 (1.60%)  24/1251 (1.92%) 
Lower respiratory tract and lung infections * 1  16/1253 (1.28%)  14/1251 (1.12%) 
Papilloma viral infections * 1  12/1253 (0.96%)  17/1251 (1.36%) 
Bacterial infections NEC * 1  15/1253 (1.20%)  11/1251 (0.88%) 
Eye and eyelid infections * 1  9/1253 (0.72%)  17/1251 (1.36%) 
Skin structures and soft tissue infections * 1  11/1253 (0.88%)  14/1251 (1.12%) 
Dental and oral soft tissue infections * 1  9/1253 (0.72%)  14/1251 (1.12%) 
Ectoparasitic infestations * 1  8/1253 (0.64%)  15/1251 (1.20%) 
Ear infections * 1  8/1253 (0.64%)  10/1251 (0.80%) 
Staphylococcal infections * 1  10/1253 (0.80%)  5/1251 (0.40%) 
Tinea infections * 1  6/1253 (0.48%)  8/1251 (0.64%) 
Influenza viral infections * 1  5/1253 (0.40%)  5/1251 (0.40%) 
Infections NEC * 1  5/1253 (0.40%)  4/1251 (0.32%) 
Male reproductive tract infections * 1  3/1253 (0.24%)  5/1251 (0.40%) 
Fungal infections NEC * 1  5/1253 (0.40%)  1/1251 (0.08%) 
Hepatitis viral infections * 1  1/1253 (0.08%)  4/1251 (0.32%) 
Candida infections * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Molluscum contagiosum viral infections * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Epstein-Barr viral infections * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Giardia infections * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Tuberculous infections * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Amoebic infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Bone and joint infections * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Caliciviral infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Clostridia infections * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Coxsackie viral infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Cytomegaloviral infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Escherichia infections * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Haemophilus infections * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Helicobacter infections * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Nematode infections * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Injury, poisoning and procedural complications     
Any event in SOC * 1  108/1253 (8.62%)  101/1251 (8.07%) 
Skin injuries NEC * 1  28/1253 (2.23%)  20/1251 (1.60%) 
Muscle, tendon and ligament injuries * 1  24/1253 (1.92%)  23/1251 (1.84%) 
Non-site specific injuries NEC * 1  13/1253 (1.04%)  9/1251 (0.72%) 
Non-site specific procedural complications * 1  12/1253 (0.96%)  8/1251 (0.64%) 
Limb fractures and dislocations * 1  9/1253 (0.72%)  10/1251 (0.80%) 
Site specific injuries NEC * 1  8/1253 (0.64%)  8/1251 (0.64%) 
Neurological and psychiatric procedural complications * 1  10/1253 (0.80%)  3/1251 (0.24%) 
Bone and joint injuries NEC * 1  4/1253 (0.32%)  5/1251 (0.40%) 
Thermal burns * 1  2/1253 (0.16%)  7/1251 (0.56%) 
Exposures to agents or circumstances NEC * 1  4/1253 (0.32%)  2/1251 (0.16%) 
Radiation injuries * 1  3/1253 (0.24%)  3/1251 (0.24%) 
Cerebral injuries NEC * 1  3/1253 (0.24%)  2/1251 (0.16%) 
Fractures and dislocations NEC * 1  1/1253 (0.08%)  4/1251 (0.32%) 
Eye injuries NEC * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Skull fractures, facial bone fractures and dislocations * 1  0/1253 (0.00%)  3/1251 (0.24%) 
Thoracic cage fractures and dislocations * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Chest and lung injuries NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Gastrointestinal and hepatobiliary procedural complications * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Ear injuries NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Overdoses NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Poisoning and toxicity * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Reproductive system and breast injuries * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Spinal fractures and dislocations * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Vaccination related complications * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Investigations     
Any event in SOC * 1  39/1253 (3.11%)  63/1251 (5.04%) 
Vascular tests NEC (incl blood pressure) * 1  28/1253 (2.23%)  47/1251 (3.76%) 
Reproductive hormone analyses * 1  3/1253 (0.24%)  7/1251 (0.56%) 
Liver function analyses * 1  3/1253 (0.24%)  3/1251 (0.24%) 
Red blood cell analyses * 1  2/1253 (0.16%)  2/1251 (0.16%) 
Carbohydrate tolerance analyses (incl diabetes) * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Digestive enzymes * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Mineral and electrolyte analyses * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Platelet analyses * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Bacteria identification and serology (excl mycobacteria) * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Cardiac auscultatory investigations * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Coagulation and bleeding analyses * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Heart rate and pulse investigations * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Investigations NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Musculoskeletal and soft tissue tests NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Mycobacteria identification and serology * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Tissue enzyme analyses NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
White blood cell analyses * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Metabolism and nutrition disorders     
Any event in SOC * 1  27/1253 (2.15%)  20/1251 (1.60%) 
Diabetes mellitus (incl subtypes) * 1  7/1253 (0.56%)  3/1251 (0.24%) 
Fat soluble vitamin deficiencies and disorders * 1  3/1253 (0.24%)  5/1251 (0.40%) 
Appetite disorders * 1  5/1253 (0.40%)  1/1251 (0.08%) 
Elevated cholesterol * 1  2/1253 (0.16%)  3/1251 (0.24%) 
Disorders of purine metabolism * 1  3/1253 (0.24%)  0/1251 (0.00%) 
General nutritional disorders NEC * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Potassium imbalance * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Fluid intake increased * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Food malabsorption and intolerance syndromes (excl sugar intolerance) * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Lipid metabolism and deposit disorders NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Water soluble vitamin deficiencies * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Elevated triglycerides * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Hyperlipidaemias NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Hypoglycaemic conditions NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Magnesium metabolism disorders * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Protein metabolism disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Sugar intolerance (excl glucose intolerance) * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Total fluid volume decreased * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Musculoskeletal and connective tissue disorders     
Any event in SOC * 1  97/1253 (7.74%)  107/1251 (8.55%) 
Musculoskeletal and connective tissue pain and discomfort * 1  47/1253 (3.75%)  49/1251 (3.92%) 
Muscle pains * 1  25/1253 (2.00%)  24/1251 (1.92%) 
Joint related signs and symptoms * 1  17/1253 (1.36%)  19/1251 (1.52%) 
Muscle related signs and symptoms NEC * 1  7/1253 (0.56%)  2/1251 (0.16%) 
Tendon disorders * 1  3/1253 (0.24%)  3/1251 (0.24%) 
Bone related signs and symptoms * 1  2/1253 (0.16%)  3/1251 (0.24%) 
Arthropathies NEC * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Bone disorders NEC * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Bursal disorders * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Intervertebral disc disorders NEC * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Muscle weakness conditions * 1  0/1253 (0.00%)  3/1251 (0.24%) 
Muscle tone abnormalities * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Cartilage disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Extremity deformities * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Joint related disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Musculoskeletal and connective tissue infections and inflammations NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Osteoarthropathies * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Rheumatoid arthropathies * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Soft tissue disorders NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Synovial disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Any event in SOC * 1  18/1253 (1.44%)  17/1251 (1.36%) 
Skin neoplasms benign * 1  13/1253 (1.04%)  14/1251 (1.12%) 
Lip and oral cavity neoplasms benign * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Skin neoplasms malignant and unspecified (excl melanoma) * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Soft tissue neoplasms benign NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Nervous system neoplasms benign NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Reproductive neoplasms male benign NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Nervous system disorders     
Any event in SOC * 1  103/1253 (8.22%)  88/1251 (7.03%) 
Headaches NEC * 1  39/1253 (3.11%)  41/1251 (3.28%) 
Neurological signs and symptoms NEC * 1  30/1253 (2.39%)  22/1251 (1.76%) 
Paraesthesias and dysaesthesias * 1  10/1253 (0.80%)  11/1251 (0.88%) 
Migraine headaches * 1  8/1253 (0.64%)  2/1251 (0.16%) 
Sensory abnormalities NEC * 1  8/1253 (0.64%)  1/1251 (0.08%) 
Disturbances in consciousness NEC * 1  7/1253 (0.56%)  1/1251 (0.08%) 
Mononeuropathies * 1  2/1253 (0.16%)  3/1251 (0.24%) 
Peripheral neuropathies NEC * 1  4/1253 (0.32%)  1/1251 (0.08%) 
Lumbar spinal cord and nerve root disorders * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Narcolepsy and hypersomnia * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Seizures and seizure disorders NEC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Cervical spinal cord and nerve root disorders * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Coordination and balance disturbances * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Disturbances in sleep phase rhythm * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Facial cranial nerve disorders * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Memory loss (excl dementia) * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Mental impairment (excl dementia and memory loss) * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Neurologic visual problems NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Sleep disturbances NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Psychiatric disorders     
Any event in SOC * 1  72/1253 (5.75%)  65/1251 (5.20%) 
Depressive disorders * 1  25/1253 (2.00%)  22/1251 (1.76%) 
Anxiety symptoms * 1  20/1253 (1.60%)  17/1251 (1.36%) 
Disturbances in initiating and maintaining sleep * 1  8/1253 (0.64%)  12/1251 (0.96%) 
Substance related and addictive disorders * 1  9/1253 (0.72%)  4/1251 (0.32%) 
Attention deficit and disruptive behaviour disorders * 1  3/1253 (0.24%)  4/1251 (0.32%) 
Anxiety disorders NEC * 1  5/1253 (0.40%)  1/1251 (0.08%) 
Bipolar disorders * 1  2/1253 (0.16%)  3/1251 (0.24%) 
Panic attacks and disorders * 1  3/1253 (0.24%)  2/1251 (0.16%) 
Sexual desire disorders * 1  3/1253 (0.24%)  2/1251 (0.16%) 
Stress disorders * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Emotional and mood disturbances NEC * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Schizophrenia NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Behaviour and socialisation disturbances * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Fear symptoms and phobic disorders (incl social phobia) * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Fluctuating mood symptoms * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Mental disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Mood alterations with depressive symptoms * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Mood disorders NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Schizoaffective and schizophreniform disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Sleep disorders NEC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Somatic symptom disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Suicidal and self-injurious behaviour * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Renal and urinary disorders     
Any event in SOC * 1  19/1253 (1.52%)  23/1251 (1.84%) 
Bladder and urethral symptoms * 1  11/1253 (0.88%)  12/1251 (0.96%) 
Renal lithiasis * 1  4/1253 (0.32%)  6/1251 (0.48%) 
Urethral disorders NEC * 1  1/1253 (0.08%)  4/1251 (0.32%) 
Urinary abnormalities * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Urinary tract signs and symptoms NEC * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Bladder neoplasms * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Reproductive system and breast disorders     
Any event in SOC * 1  27/1253 (2.15%)  26/1251 (2.08%) 
Penile disorders NEC (excl erection and ejaculation) * 1  12/1253 (0.96%)  7/1251 (0.56%) 
Reproductive tract signs and symptoms NEC * 1  5/1253 (0.40%)  4/1251 (0.32%) 
Erection and ejaculation conditions and disorders * 1  1/1253 (0.08%)  5/1251 (0.40%) 
Prostate and seminal vesicles infections and inflammations * 1  2/1253 (0.16%)  4/1251 (0.32%) 
Reproductive tract disorders NEC (excl neoplasms) * 1  3/1253 (0.24%)  1/1251 (0.08%) 
Testicular and epididymal disorders NEC * 1  3/1253 (0.24%)  1/1251 (0.08%) 
Breast signs and symptoms * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Scrotal disorders NEC * 1  0/1253 (0.00%)  2/1251 (0.16%) 
Breast disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Pelvic prolapse conditions * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Sexual function and fertility disorders NEC * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Spermatogenesis and semen disorders * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Testicular and epididymal neoplasms * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Respiratory, thoracic and mediastinal disorders     
Any event in SOC * 1  123/1253 (9.82%)  95/1251 (7.59%) 
Upper respiratory tract signs and symptoms * 1  49/1253 (3.91%)  44/1251 (3.52%) 
Coughing and associated symptoms * 1  34/1253 (2.71%)  24/1251 (1.92%) 
Nasal congestion and inflammations * 1  22/1253 (1.76%)  17/1251 (1.36%) 
Paranasal sinus disorders (excl infections and neoplasms) * 1  15/1253 (1.20%)  10/1251 (0.80%) 
Bronchospasm and obstruction * 1  7/1253 (0.56%)  6/1251 (0.48%) 
Pharyngeal disorders (excl infections and neoplasms) * 1  5/1253 (0.40%)  4/1251 (0.32%) 
Breathing abnormalities * 1  5/1253 (0.40%)  3/1251 (0.24%) 
Nasal disorders NEC * 1  2/1253 (0.16%)  4/1251 (0.32%) 
Respiratory tract disorders NEC * 1  3/1253 (0.24%)  1/1251 (0.08%) 
Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms) * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Pulmonary oedemas * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Respiratory failures (excl neonatal) * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Skin and subcutaneous tissue disorders     
Any event in SOC * 1  112/1253 (8.94%)  86/1251 (6.87%) 
Dermatitis and eczema * 1  29/1253 (2.31%)  17/1251 (1.36%) 
Rashes, eruptions and exanthems NEC * 1  21/1253 (1.68%)  25/1251 (2.00%) 
Apocrine and eccrine gland disorders * 1  17/1253 (1.36%)  11/1251 (0.88%) 
Dermal and epidermal conditions NEC * 1  11/1253 (0.88%)  11/1251 (0.88%) 
Pruritus NEC * 1  14/1253 (1.12%)  8/1251 (0.64%) 
Erythemas * 1  7/1253 (0.56%)  2/1251 (0.16%) 
Psoriatic conditions * 1  6/1253 (0.48%)  3/1251 (0.24%) 
Acnes * 1  3/1253 (0.24%)  3/1251 (0.24%) 
Angioedemas * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Bullous conditions * 1  2/1253 (0.16%)  1/1251 (0.08%) 
Papulosquamous conditions * 1  1/1253 (0.08%)  2/1251 (0.16%) 
Pilar disorders NEC * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Purpura and related conditions * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Skin and subcutaneous tissue ulcerations * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Skin cysts and polyps * 1  1/1253 (0.08%)  1/1251 (0.08%) 
Skin preneoplastic conditions NEC * 1  2/1253 (0.16%)  0/1251 (0.00%) 
Alopecias * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Dermatitis ascribed to specific agent * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Hyperkeratoses * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Hyperpigmentation disorders * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Photosensitivity and photodermatosis conditions * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Rosaceas * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Social circumstances     
Any event in SOC * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Crime victims * 1  0/1253 (0.00%)  1/1251 (0.08%) 
Vascular disorders     
Any event in SOC * 1  33/1253 (2.63%)  49/1251 (3.92%) 
Vascular hypertensive disorders NEC * 1  25/1253 (2.00%)  42/1251 (3.36%) 
Peripheral vascular disorders NEC * 1  5/1253 (0.40%)  4/1251 (0.32%) 
Haemorrhages NEC * 1  2/1253 (0.16%)  2/1251 (0.16%) 
Lymphoedemas * 1  1/1253 (0.08%)  0/1251 (0.00%) 
Peripheral embolism and thrombosis * 1  0/1253 (0.00%)  1/1251 (0.08%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
EMail: jandries@fredhutch.org
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00865566     History of Changes
Obsolete Identifiers: NCT00919789
Other Study ID Numbers: HVTN 505
10753 ( Registry Identifier: DAIDS ES )
First Submitted: March 17, 2009
First Posted: March 19, 2009
Results First Submitted: October 8, 2018
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019