Trial Outcomes & Findings for Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult. (NCT NCT05182125)
NCT ID: NCT05182125
Last Updated: 2025-12-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
Results posted on
2025-12-24
Participant Flow
Participant milestones
| Measure |
Part A, Group 1: Vaccine
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 3: Placebo
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
2
|
10
|
10
|
2
|
|
Overall Study
COMPLETED
|
5
|
5
|
2
|
9
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
Part A, Group 1: Vaccine
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 3: Placebo
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Participant unable to adhere Visit Schedule
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult.
Baseline characteristics by cohort
| Measure |
Part A, Group 1: Vaccine
n=5 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
23 years
n=30 Participants
|
23 years
n=30 Participants
|
24.5 years
n=60 Participants
|
28 years
n=219 Participants
|
28 years
n=880 Participants
|
21.5 years
n=5449 Participants
|
25.5 years
n=391 Participants
|
|
Age, Customized
Less than 18
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Age, Customized
18-20
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
1 Participants
n=5449 Participants
|
7 Participants
n=391 Participants
|
|
Age, Customized
21-30
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
6 Participants
n=219 Participants
|
5 Participants
n=880 Participants
|
1 Participants
n=5449 Participants
|
18 Participants
n=391 Participants
|
|
Age, Customized
31-40
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=219 Participants
|
4 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
9 Participants
n=391 Participants
|
|
Age, Customized
41-50
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Age, Customized
Age Category : Above 50
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=219 Participants
|
5 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
12 Participants
n=391 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
7 Participants
n=219 Participants
|
5 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
22 Participants
n=391 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
10 Participants
n=219 Participants
|
10 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
34 Participants
n=391 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
10 Participants
n=219 Participants
|
10 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
34 Participants
n=391 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
10 Participants
n=219 Participants
|
10 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
34 Participants
n=391 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Colored
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Region of Enrollment
South Africa
|
5 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
10 Participants
n=219 Participants
|
10 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
34 Participants
n=391 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).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.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=5 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
None
|
1 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Mild
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Moderate
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).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.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=5 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
2 Participants
|
10 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
2 Participants
|
10 Participants
|
10 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).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.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=5 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
2 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
2 Participants
|
10 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
0 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
2 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
2 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
2 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
2 Participants
|
7 Participants
|
9 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
2 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Early study termination reason was collected through 7 days for reactogenicity, 30 days for AEs and 12 months for deaths following any receipt of study product (up to 18 months).Population: Safety population
From the termination and adverse event forms that were collected during main study clinical visits period and AESI contact visits. Counts are tabulated by treatment arm.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=5 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits.
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).Population: Safety population
From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=5 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).Population: Safety population
From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=5 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).Population: Safety population
From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=5 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Event of Special Interests (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 1 for both Part A and Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI\*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=8 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=4 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=4 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-BF1266_431a_V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
1086C_D7gp120.avi/293F measured at Month 1
|
0 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
1394C9_G1.D11gp120.avi measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
1428_D11gp120.avi/293F measured at Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
1641A7_D11gp120.avi/293F measured at Month 1
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CAP210_D11gp120.avi/293F measured at Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CAP45_D11gp120.avi/293F measured at Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH505TFD8N156KN160K_avi/293i Mon measured at Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Ce0042_D11gp120.avi/293F measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Con S gp140 CFI measured at Month 1
|
0 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Du156_D11gp120.avi/293F measured at Month 1
|
0 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp41 measured at Month 1
|
0 Participants
|
8 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-001428.2.42 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-1012.11.TC21.3257 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-1051.12.C22 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-1394C9G1 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-7060101641 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-96ZM651.02 V1v2 measured at Month 1
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-CAP210.2.00.E8 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-CAP45.2.00.G3 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-Ce1086_B2 V1V2 measured at Month 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-Ce1176 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-Ce704010042_2ES V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-ConC V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-Du156.12 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
96ZM651.D11gp120.avi measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH0505_CON D7gp120_avi/293F/Mon measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH505TF D7gp120d371_avi/293F/Mon measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Con 6 gp120/B measured at Month 1
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
TV1c8_D11gp120.avi/293F measured at Month 1
|
0 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-TV1.21 V1V2 measured at Month 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70_CH505TF_V1V2_avi/293F measured at Month 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 1 for both Part A and Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate).
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=8 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=4 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=4 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CAP210_D11gp120.avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
291.5 Net MFI
Interval 58.6 to 469.1
|
1 Net MFI
Interval 1.0 to 458.9
|
2725.2 Net MFI
Interval 1363.1 to 4087.4
|
68.6 Net MFI
Interval 1.0 to 317.6
|
81.9 Net MFI
Interval 32.7 to 438.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CAP45_D11gp120.avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
89.6 Net MFI
Interval 61.2 to 280.8
|
41.8 Net MFI
Interval 1.0 to 101.6
|
345.8 Net MFI
Interval 173.4 to 518.1
|
25.4 Net MFI
Interval 11.9 to 80.1
|
7.1 Net MFI
Interval 2.1 to 51.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH0505_CON D7gp120_avi/293F/Mon measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
137 Net MFI
Interval 1.0 to 230.0
|
1 Net MFI
Interval 1.0 to 131.9
|
3306.9 Net MFI
Interval 1653.9 to 4959.8
|
71.6 Net MFI
Interval 1.0 to 281.5
|
336.5 Net MFI
Interval 16.6 to 801.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH505TFD8N156KN160K_avi/293i Mon measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
124.5 Net MFI
Interval 2.1 to 225.5
|
1 Net MFI
Interval 1.0 to 206.4
|
1 Net MFI
Interval 1.0 to 1.0
|
104.8 Net MFI
Interval 1.0 to 348.7
|
292.6 Net MFI
Interval 20.9 to 745.1
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
96ZM651.D11gp120.avi measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
497.1 Net MFI
Interval 89.9 to 851.5
|
27 Net MFI
Interval 1.0 to 884.4
|
1 Net MFI
Interval 1.0 to 1.0
|
54.8 Net MFI
Interval 36.2 to 724.5
|
186.9 Net MFI
Interval 82.0 to 2016.1
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH505TF D7gp120d371_avi/293F/Mon measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
136.1 Net MFI
Interval 1.0 to 268.7
|
1 Net MFI
Interval 1.0 to 60.6
|
3192 Net MFI
Interval 1596.5 to 4787.5
|
63.2 Net MFI
Interval 1.0 to 248.2
|
347 Net MFI
Interval 3.6 to 830.3
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Ce0042_D11gp120.avi/293F measured at Month 1
|
23.9 Net MFI
Interval 12.4 to 35.3
|
167.2 Net MFI
Interval 113.2 to 208.2
|
109.2 Net MFI
Interval 13.8 to 229.9
|
365.6 Net MFI
Interval 183.3 to 547.9
|
103.2 Net MFI
Interval 58.3 to 205.7
|
103 Net MFI
Interval 95.0 to 273.9
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
1086C_D7gp120.avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
371.8 Net MFI
Interval 153.4 to 1041.7
|
164.5 Net MFI
Interval 1.0 to 612.6
|
8.1 Net MFI
Interval 4.6 to 11.7
|
691.2 Net MFI
Interval 435.0 to 907.1
|
65.8 Net MFI
Interval 7.4 to 229.6
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-7060101641 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 251.2
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
1394C9_G1.D11gp120.avi measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
22.2 Net MFI
Interval 3.2 to 35.6
|
40.9 Net MFI
Interval 1.0 to 144.7
|
1 Net MFI
Interval 1.0 to 1.0
|
3.5 Net MFI
Interval 1.0 to 27.1
|
1.2 Net MFI
Interval 1.0 to 2.6
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
1428_D11gp120.avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
178.6 Net MFI
Interval 122.2 to 539.3
|
3 Net MFI
Interval 1.0 to 210.1
|
1874 Net MFI
Interval 937.5 to 2810.5
|
1 Net MFI
Interval 1.0 to 165.8
|
57.4 Net MFI
Interval 16.4 to 341.9
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
1641A7_D11gp120.avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
238.6 Net MFI
Interval 116.8 to 921.8
|
23 Net MFI
Interval 1.0 to 402.4
|
92.5 Net MFI
Interval 46.8 to 138.2
|
1 Net MFI
Interval 1.0 to 87.8
|
25.1 Net MFI
Interval 1.0 to 52.8
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-96ZM651.02 V1v2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
679.8 Net MFI
Interval 434.8 to 2164.2
|
365.2 Net MFI
Interval 112.4 to 1161.6
|
1 Net MFI
Interval 1.0 to 1.0
|
443.5 Net MFI
Interval 37.2 to 1604.8
|
2.5 Net MFI
Interval 1.0 to 96.8
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-BF1266_431a_V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
166.5 Net MFI
Interval 1.0 to 913.2
|
1 Net MFI
Interval 1.0 to 1.0
|
26.8 Net MFI
Interval 1.0 to 330.1
|
1.6 Net MFI
Interval 1.0 to 78.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-CAP210.2.00.E8 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
263.5 Net MFI
Interval 66.2 to 965.2
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 35.4
|
65.2 Net MFI
Interval 43.9 to 618.6
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-CAP45.2.00.G3 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 636.2
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-Ce1086_B2 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
6.5 Net MFI
Interval 1.0 to 81.5
|
1 Net MFI
Interval 1.0 to 533.0
|
1 Net MFI
Interval 1.0 to 1.0
|
29.9 Net MFI
Interval 1.0 to 61.3
|
1 Net MFI
Interval 1.0 to 251.9
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-Ce1176 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
232.2 Net MFI
Interval 12.0 to 452.5
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
70.2 Net MFI
Interval 13.0 to 360.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-Ce704010042_2ES V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 7.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-ConC V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 178.4
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-Du156.12 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 5.3
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-TV1.21 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1173 Net MFI
Interval 80.8 to 2925.8
|
15.8 Net MFI
Interval 8.4 to 23.1
|
1800.6 Net MFI
Interval 1.0 to 3984.3
|
183.6 Net MFI
Interval 37.2 to 1832.3
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 13.0
|
62.2 Net MFI
Interval 1.0 to 603.9
|
79.2 Net MFI
Interval 79.2 to 79.2
|
425.9 Net MFI
Interval 1.0 to 1156.0
|
59.6 Net MFI
Interval 1.0 to 1378.8
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70_CH505TF_V1V2_avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 322.0
|
929.6 Net MFI
Interval 49.1 to 2142.9
|
283.2 Net MFI
Interval 283.2 to 283.2
|
1 Net MFI
Interval 1.0 to 2274.4
|
1 Net MFI
Interval 1.0 to 150.6
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Con 6 gp120/B measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
36.5 Net MFI
Interval 8.2 to 45.3
|
1 Net MFI
Interval 1.0 to 59.7
|
12 Net MFI
Interval 6.5 to 17.5
|
38.9 Net MFI
Interval 1.0 to 88.1
|
36.1 Net MFI
Interval 4.9 to 91.8
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Con S gp140 CFI measured at Month 1
|
8.6 Net MFI
Interval 4.8 to 12.4
|
3530.2 Net MFI
Interval 1597.1 to 13418.8
|
650.2 Net MFI
Interval 242.9 to 3709.0
|
575 Net MFI
Interval 312.2 to 837.8
|
436.5 Net MFI
Interval 255.8 to 1292.8
|
272.1 Net MFI
Interval 23.4 to 645.4
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Du156_D11gp120.avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
615.2 Net MFI
Interval 418.6 to 1879.2
|
14 Net MFI
Interval 1.0 to 383.9
|
62 Net MFI
Interval 31.5 to 92.5
|
61.9 Net MFI
Interval 44.1 to 806.5
|
7.9 Net MFI
Interval 1.0 to 16.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
TV1c8_D11gp120.avi/293F measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1227.5 Net MFI
Interval 650.2 to 3362.1
|
20.6 Net MFI
Interval 1.0 to 199.2
|
152 Net MFI
Interval 76.5 to 227.5
|
101.9 Net MFI
Interval 11.5 to 1434.0
|
1 Net MFI
Interval 1.0 to 26.8
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp41 measured at Month 1
|
2214.9 Net MFI
Interval 1902.8 to 2526.9
|
22000 Net MFI
Interval 9936.3 to 22000.0
|
13128 Net MFI
Interval 6580.5 to 16682.2
|
1268.5 Net MFI
Interval 882.1 to 1654.9
|
5349.6 Net MFI
Interval 3079.3 to 11108.9
|
3582.8 Net MFI
Interval 3573.8 to 3855.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-001428.2.42 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1149.1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 17.9
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-1012.11.TC21.3257 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
79 Net MFI
Interval 1.0 to 238.4
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 230.9
|
1 Net MFI
Interval 1.0 to 22.2
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-1051.12.C22 V1V2 measured at Month 1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
41.6 Net MFI
Interval 1.0 to 304.6
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 42.9
|
|
Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
gp70-1394C9G1 V1V2 measured at Month 1
|
22.9 Net MFI
Interval 11.9 to 33.8
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 692.1
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 54.9
|
SECONDARY outcome
Timeframe: Measured at Month 1 for both Part A and Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI \>100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=8 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=4 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=4 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC (AUC--MB) by Panel and Treatment Arm Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Clade C gp120 measured at Month 1
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
2.19 log10(net MFI)
Interval 2.14 to 2.37
|
2 log10(net MFI)
Interval 2.0 to 2.09
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
2 log10(net MFI)
Interval 2.0 to 2.08
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
|
HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC (AUC--MB) by Panel and Treatment Arm Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Clade C gp70 V1V2 measured at Month 1
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
2 log10(net MFI)
Interval 2.0 to 2.12
|
2.12 log10(net MFI)
Interval 2.03 to 2.18
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
2.05 log10(net MFI)
Interval 2.0 to 2.11
|
2 log10(net MFI)
Interval 2.0 to 2.07
|
SECONDARY outcome
Timeframe: Measured at Month 1 for both Part A and Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=9 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=8 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=4 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=4 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Any Env for CD4+ T Cells, measured at Month 1
|
0 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Any Env for CD8+ T Cells, measured at Month 1
|
1 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1
|
1 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1
|
0 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 1 for both Part A and Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
PBMC samples were stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=9 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=8 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=4 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=4 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Any Env for CD8+ T Cells, measured at Month 1
|
0.028 Percentage of cells
Interval 0.016 to 0.041
|
0.044 Percentage of cells
Interval 0.007 to 0.091
|
0.067 Percentage of cells
Interval 0.041 to 0.126
|
0.025 Percentage of cells
Interval 0.021 to 0.029
|
0.011 Percentage of cells
Interval 0.001 to 0.022
|
0.096 Percentage of cells
Interval 0.035 to 0.189
|
|
Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Any Env for CD4+ T Cells, measured at Month 1
|
0.001 Percentage of cells
Interval 0.001 to 0.001
|
0.028 Percentage of cells
Interval 0.001 to 0.055
|
0.13 Percentage of cells
Interval 0.053 to 0.162
|
0.011 Percentage of cells
Interval 0.006 to 0.017
|
0.019 Percentage of cells
Interval 0.005 to 0.043
|
0.103 Percentage of cells
Interval 0.096 to 0.119
|
|
Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1
|
0.001 Percentage of cells
Interval 0.001 to 0.001
|
0.008 Percentage of cells
Interval 0.001 to 0.019
|
0.047 Percentage of cells
Interval 0.025 to 0.064
|
0.011 Percentage of cells
Interval 0.006 to 0.016
|
0.008 Percentage of cells
Interval 0.005 to 0.015
|
0.066 Percentage of cells
Interval 0.047 to 0.084
|
|
Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1
|
0.017 Percentage of cells
Interval 0.01 to 0.024
|
0.028 Percentage of cells
Interval 0.007 to 0.033
|
0.033 Percentage of cells
Interval 0.021 to 0.094
|
0.016 Percentage of cells
Interval 0.009 to 0.022
|
0.011 Percentage of cells
Interval 0.001 to 0.022
|
0.038 Percentage of cells
Interval 0.025 to 0.11
|
|
Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1
|
0.001 Percentage of cells
Interval 0.001 to 0.001
|
0.019 Percentage of cells
Interval 0.001 to 0.036
|
0.065 Percentage of cells
Interval 0.032 to 0.093
|
0.001 Percentage of cells
Interval 0.001 to 0.001
|
0.011 Percentage of cells
Interval 0.001 to 0.028
|
0.049 Percentage of cells
Interval 0.037 to 0.058
|
|
Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1
|
0.012 Percentage of cells
Interval 0.006 to 0.017
|
0.014 Percentage of cells
Interval 0.001 to 0.023
|
0.023 Percentage of cells
Interval 0.011 to 0.048
|
0.009 Percentage of cells
Interval 0.006 to 0.012
|
0.001 Percentage of cells
Interval 0.001 to 0.001
|
0.011 Percentage of cells
Interval 0.007 to 0.035
|
SECONDARY outcome
Timeframe: Measured at Month 1 for both Part A and Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=8 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=4 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=4 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH505TF at dilution 50, measured at Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH505TF at dilution 80, measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
DU172.17 at dilution 50, measured at Month 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
DU172.17 at dilution 80, measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Du422.1 at dilution 50, measured at Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Du422.1 at dilution 80, measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
MW965.26 at dilution 50, measured at Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
MW965.26 at dilution 80, measured at Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 1 for both Part A and Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26).
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 Participants
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=8 Participants
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 Participants
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=4 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=4 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH505TF at dilution 50, measured at Month 1
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 7.1
|
|
Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
CH505TF at dilution 80, measured at Month 1
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
DU172.17 at dilution 50, measured at Month 1
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
DU172.17 at dilution 80, measured at Month 1
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Du422.1 at dilution 50, measured at Month 1
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
Du422.1 at dilution 80, measured at Month 1
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
MW965.26 at dilution 50, measured at Month 1
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)
MW965.26 at dilution 80, measured at Month 1
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Measured at Month 4 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI\*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=9 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=8 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
1086C_D7gp120.avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
9 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
1394C9_G1.D11gp120.avi measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
4 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
1428_D11gp120.avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
7 Participants
|
4 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
1641A7_D11gp120.avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
96ZM651.D11gp120.avi measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
6 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CAP210_D11gp120.avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
5 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CAP45_D11gp120.avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
6 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CH0505_CON D7gp120_avi/293F/Mon measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
5 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CH505TF D7gp120d371_avi/293F/Mon measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
6 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CH505TFD8N156KN160K_avi/293i Mon measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
6 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
Ce0042_D11gp120.avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
Con 6 gp120/B measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
Con S gp140 CFI measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
9 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
Du156_D11gp120.avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
9 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
TV1c8_D11gp120.avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
9 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp41 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
5 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-001428.2.42 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-1012.11.TC21.3257 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-1051.12.C22 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
4 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-1394C9G1 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-7060101641 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-96ZM651.02 V1v2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-BF1266_431a_V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-CAP210.2.00.E8 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-CAP45.2.00.G3 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-Ce1086_B2 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-Ce1176 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-Ce704010042_2ES V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-ConC V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-Du156.12 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-TV1.21 V1V2 measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70_CH505TF_V1V2_avi/293F measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 4 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate).
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=9 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=8 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 4
|
93.8 Net MFI
Interval 93.8 to 93.8
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 1.0
|
244 Net MFI
Interval 50.2 to 461.6
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CH505TFD8N156KN160K_avi/293i Mon measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1826.2 Net MFI
Interval 356.0 to 3587.5
|
364 Net MFI
Interval 218.0 to 10714.8
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-Ce1176 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 1.0
|
114.8 Net MFI
Interval 8.4 to 1575.8
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-Du156.12 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 2.7
|
1 Net MFI
Interval 1.0 to 12.1
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
1086C_D7gp120.avi/293F measured at Month 4
|
15.2 Net MFI
Interval 8.1 to 22.4
|
—
|
—
|
—
|
7160.2 Net MFI
Interval 2493.0 to 22000.0
|
5318.9 Net MFI
Interval 1591.6 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
1394C9_G1.D11gp120.avi measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
287.2 Net MFI
Interval 189.2 to 1066.5
|
168.6 Net MFI
Interval 99.9 to 2388.9
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
1428_D11gp120.avi/293F measured at Month 4
|
2131.1 Net MFI
Interval 1066.1 to 3196.2
|
—
|
—
|
—
|
1886 Net MFI
Interval 1202.5 to 11290.0
|
1826.8 Net MFI
Interval 453.2 to 12090.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
1641A7_D11gp120.avi/293F measured at Month 4
|
104.5 Net MFI
Interval 52.8 to 156.2
|
—
|
—
|
—
|
2174.2 Net MFI
Interval 1228.0 to 13183.5
|
2312.1 Net MFI
Interval 673.7 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
96ZM651.D11gp120.avi measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
3297.8 Net MFI
Interval 884.5 to 8019.0
|
844.8 Net MFI
Interval 657.5 to 12190.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CAP210_D11gp120.avi/293F measured at Month 4
|
3179.5 Net MFI
Interval 1590.2 to 4768.8
|
—
|
—
|
—
|
1553 Net MFI
Interval 502.5 to 9846.8
|
437.5 Net MFI
Interval 250.4 to 11716.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CAP45_D11gp120.avi/293F measured at Month 4
|
388.6 Net MFI
Interval 194.8 to 582.4
|
—
|
—
|
—
|
595.5 Net MFI
Interval 386.0 to 3380.2
|
653.6 Net MFI
Interval 251.8 to 11100.8
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CH0505_CON D7gp120_avi/293F/Mon measured at Month 4
|
3982.1 Net MFI
Interval 1991.6 to 5972.7
|
—
|
—
|
—
|
1790.2 Net MFI
Interval 359.2 to 3655.2
|
355 Net MFI
Interval 242.1 to 11501.5
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
CH505TF D7gp120d371_avi/293F/Mon measured at Month 4
|
3744.6 Net MFI
Interval 1872.8 to 5616.4
|
—
|
—
|
—
|
1589.8 Net MFI
Interval 289.5 to 4195.2
|
340.2 Net MFI
Interval 184.2 to 11551.4
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
Ce0042_D11gp120.avi/293F measured at Month 4
|
457 Net MFI
Interval 229.0 to 685.0
|
—
|
—
|
—
|
561.2 Net MFI
Interval 161.0 to 1006.5
|
207 Net MFI
Interval 174.8 to 4715.1
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
Con 6 gp120/B measured at Month 4
|
27.5 Net MFI
Interval 14.2 to 40.8
|
—
|
—
|
—
|
889 Net MFI
Interval 491.2 to 4699.8
|
979.9 Net MFI
Interval 94.2 to 6685.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
Con S gp140 CFI measured at Month 4
|
654.1 Net MFI
Interval 337.1 to 971.2
|
—
|
—
|
—
|
22000 Net MFI
Interval 19531.5 to 22000.0
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
Du156_D11gp120.avi/293F measured at Month 4
|
84.4 Net MFI
Interval 42.7 to 126.1
|
—
|
—
|
—
|
3444.8 Net MFI
Interval 2452.5 to 21158.0
|
5790.4 Net MFI
Interval 1533.3 to 20619.8
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
TV1c8_D11gp120.avi/293F measured at Month 4
|
197.8 Net MFI
Interval 99.4 to 296.1
|
—
|
—
|
—
|
5688.5 Net MFI
Interval 3846.0 to 22000.0
|
9944.1 Net MFI
Interval 1892.9 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp41 measured at Month 4
|
1532.9 Net MFI
Interval 1025.3 to 2040.4
|
—
|
—
|
—
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-001428.2.42 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 20.2
|
83.2 Net MFI
Interval 1.0 to 2134.5
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-1012.11.TC21.3257 V1V2 measured at Month 4
|
13.8 Net MFI
Interval 7.4 to 20.1
|
—
|
—
|
—
|
31.5 Net MFI
Interval 1.0 to 103.9
|
194.2 Net MFI
Interval 98.3 to 676.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-1051.12.C22 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 34.2
|
295.5 Net MFI
Interval 52.9 to 679.5
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-1394C9G1 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
7.5 Net MFI
Interval 1.0 to 79.9
|
188.5 Net MFI
Interval 1.0 to 4973.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-7060101641 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 9.5
|
1 Net MFI
Interval 1.0 to 1485.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-96ZM651.02 V1v2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
447 Net MFI
Interval 83.1 to 1022.8
|
609.8 Net MFI
Interval 270.4 to 3245.8
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-BF1266_431a_V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 97.2
|
107.8 Net MFI
Interval 18.8 to 3505.3
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-CAP210.2.00.E8 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 1.0
|
167.8 Net MFI
Interval 39.2 to 1172.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-CAP45.2.00.G3 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 5.9
|
84.5 Net MFI
Interval 1.0 to 1412.5
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-Ce1086_B2 V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
157.9 Net MFI
Interval 92.0 to 246.5
|
219.8 Net MFI
Interval 16.6 to 4753.5
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-Ce704010042_2ES V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 358.1
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-ConC V1V2 measured at Month 4
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 1.0
|
3 Net MFI
Interval 1.0 to 1500.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70-TV1.21 V1V2 measured at Month 4
|
14.2 Net MFI
Interval 7.6 to 20.9
|
—
|
—
|
—
|
42.1 Net MFI
Interval 1.0 to 59.5
|
331.6 Net MFI
Interval 1.0 to 3697.9
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination
gp70_CH505TF_V1V2_avi/293F measured at Month 4
|
307.8 Net MFI
Interval 307.8 to 307.8
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 79.7
|
1463 Net MFI
Interval 342.8 to 1770.2
|
SECONDARY outcome
Timeframe: Measured at Month 4 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI \>100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=9 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=8 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination
Clade C gp120 measured at Month 4
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
—
|
—
|
—
|
2.94 log10(net MFI)
Interval 2.51 to 3.84
|
2.64 log10(net MFI)
Interval 2.21 to 3.61
|
|
Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination
Clade C gp70 V1V2 measured at Month 4
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
—
|
—
|
—
|
2 log10(net MFI)
Interval 2.0 to 2.04
|
2.05 log10(net MFI)
Interval 2.01 to 2.45
|
SECONDARY outcome
Timeframe: Measured at Month 4 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=9 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=8 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination
Any Env for CD4+ T Cells, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination
Any Env for CD8+ T Cells, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
5 Participants
|
5 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination
ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination
ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
5 Participants
|
5 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination
ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
4 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination
ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 4 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
PBMC samples were stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=9 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=8 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After the Second Vaccination
Any Env for CD8+ T Cells, measured at Month 4
|
0.011 Percentage of cells
Interval 0.011 to 0.012
|
—
|
—
|
—
|
0.091 Percentage of cells
Interval 0.012 to 0.154
|
0.11 Percentage of cells
Interval 0.046 to 0.319
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After the Second Vaccination
Any Env for CD4+ T Cells, measured at Month 4
|
0.009 Percentage of cells
Interval 0.008 to 0.009
|
—
|
—
|
—
|
0.049 Percentage of cells
Interval 0.038 to 0.156
|
0.09 Percentage of cells
Interval 0.046 to 0.105
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After the Second Vaccination
ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 4
|
0.004 Percentage of cells
Interval 0.003 to 0.006
|
—
|
—
|
—
|
0.031 Percentage of cells
Interval 0.019 to 0.052
|
0.046 Percentage of cells
Interval 0.032 to 0.05
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After the Second Vaccination
ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 4
|
0.005 Percentage of cells
Interval 0.003 to 0.007
|
—
|
—
|
—
|
0.043 Percentage of cells
Interval 0.011 to 0.081
|
0.074 Percentage of cells
Interval 0.033 to 0.135
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After the Second Vaccination
ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 4
|
0.005 Percentage of cells
Interval 0.003 to 0.007
|
—
|
—
|
—
|
0.024 Percentage of cells
Interval 0.019 to 0.108
|
0.04 Percentage of cells
Interval 0.018 to 0.055
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After the Second Vaccination
ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 4
|
0.006 Percentage of cells
Interval 0.004 to 0.009
|
—
|
—
|
—
|
0.011 Percentage of cells
Interval 0.006 to 0.074
|
0.03 Percentage of cells
Interval 0.015 to 0.111
|
SECONDARY outcome
Timeframe: Measured at Month 4 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=9 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=8 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
CH505TF at dilution 50, measured at Month 4
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
CH505TF at dilution 80, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
DU172.17 at dilution 50, measured at Month 4
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
DU172.17 at dilution 80, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
Du422.1 at dilution 50, measured at Month 4
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
Du422.1 at dilution 80, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
MW965.26 at dilution 50, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
MW965.26 at dilution 80, measured at Month 4
|
0 Participants
|
—
|
—
|
—
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 4 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only).
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=9 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=8 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
CH505TF at dilution 50, measured at Month 4
|
9.5 titer
Interval 7.2 to 11.7
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
CH505TF at dilution 80, measured at Month 4
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
DU172.17 at dilution 50, measured at Month 4
|
7.8 titer
Interval 6.4 to 9.2
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
DU172.17 at dilution 80, measured at Month 4
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
Du422.1 at dilution 50, measured at Month 4
|
9.9 titer
Interval 7.5 to 12.4
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
Du422.1 at dilution 80, measured at Month 4
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
MW965.26 at dilution 50, measured at Month 4
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
79.2 titer
Interval 33.8 to 94.0
|
71 titer
Interval 12.1 to 109.8
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination
MW965.26 at dilution 80, measured at Month 4
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
14.6 titer
Interval 5.0 to 32.9
|
14.7 titer
Interval 5.0 to 23.5
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI\*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=8 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=7 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
1086C_D7gp120.avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
1394C9_G1.D11gp120.avi measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
1428_D11gp120.avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
1641A7_D11gp120.avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
96ZM651.D11gp120.avi measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CAP210_D11gp120.avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CAP45_D11gp120.avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CH0505_CON D7gp120_avi/293F/Mon measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CH505TF D7gp120d371_avi/293F/Mon measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CH505TFD8N156KN160K_avi/293i Mon measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
Ce0042_D11gp120.avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
Con 6 gp120/B measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
Con S gp140 CFI measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
Du156_D11gp120.avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
TV1c8_D11gp120.avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp41 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
7 Participants
|
4 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-001428.2.42 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-1012.11.TC21.3257 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-1051.12.C22 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
4 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-1394C9G1 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
4 Participants
|
4 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-7060101641 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-96ZM651.02 V1v2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-BF1266_431a_V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-CAP210.2.00.E8 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
4 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-CAP45.2.00.G3 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-Ce1086_B2 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-Ce1176 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-Ce704010042_2ES V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-ConC V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-Du156.12 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-TV1.21 V1V2 measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
|
Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70_CH505TF_V1V2_avi/293F measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate).
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=8 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=7 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-96ZM651.02 V1v2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
614.8 Net MFI
Interval 256.6 to 8476.2
|
1780.1 Net MFI
Interval 143.4 to 3878.1
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
1394C9_G1.D11gp120.avi measured at Month 6.5
|
6 Net MFI
Interval 3.5 to 8.5
|
—
|
—
|
—
|
20251.9 Net MFI
Interval 4882.5 to 22000.0
|
5330.2 Net MFI
Interval 3441.4 to 11133.6
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
1428_D11gp120.avi/293F measured at Month 6.5
|
1499.4 Net MFI
Interval 750.2 to 2248.6
|
—
|
—
|
—
|
22000 Net MFI
Interval 18414.2 to 22000.0
|
22000 Net MFI
Interval 12803.9 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
1641A7_D11gp120.avi/293F measured at Month 6.5
|
70.5 Net MFI
Interval 35.8 to 105.2
|
—
|
—
|
—
|
22000 Net MFI
Interval 18493.9 to 22000.0
|
22000 Net MFI
Interval 15769.4 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
96ZM651.D11gp120.avi measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
22000 Net MFI
Interval 21971.9 to 22000.0
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CAP210_D11gp120.avi/293F measured at Month 6.5
|
2226.2 Net MFI
Interval 1113.6 to 3338.9
|
—
|
—
|
—
|
22000 Net MFI
Interval 19094.1 to 22000.0
|
22000 Net MFI
Interval 14543.1 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
1086C_D7gp120.avi/293F measured at Month 6.5
|
13.5 Net MFI
Interval 7.2 to 19.8
|
—
|
—
|
—
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CAP45_D11gp120.avi/293F measured at Month 6.5
|
234.4 Net MFI
Interval 118.9 to 349.8
|
—
|
—
|
—
|
22000 Net MFI
Interval 12319.1 to 22000.0
|
13516.5 Net MFI
Interval 7494.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CH0505_CON D7gp120_avi/293F/Mon measured at Month 6.5
|
2943.4 Net MFI
Interval 1472.2 to 4414.6
|
—
|
—
|
—
|
22000 Net MFI
Interval 20718.1 to 22000.0
|
22000 Net MFI
Interval 16872.2 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CH505TF D7gp120d371_avi/293F/Mon measured at Month 6.5
|
2626.6 Net MFI
Interval 1313.8 to 3939.4
|
—
|
—
|
—
|
22000 Net MFI
Interval 18795.9 to 22000.0
|
22000 Net MFI
Interval 12295.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
CH505TFD8N156KN160K_avi/293i Mon measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
22000 Net MFI
Interval 21365.8 to 22000.0
|
22000 Net MFI
Interval 17977.8 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
Ce0042_D11gp120.avi/293F measured at Month 6.5
|
314.5 Net MFI
Interval 157.8 to 471.2
|
—
|
—
|
—
|
22000 Net MFI
Interval 9925.1 to 22000.0
|
11018.1 Net MFI
Interval 4555.2 to 13940.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
Con 6 gp120/B measured at Month 6.5
|
6.9 Net MFI
Interval 3.9 to 9.8
|
—
|
—
|
—
|
22000 Net MFI
Interval 18092.1 to 22000.0
|
21599.8 Net MFI
Interval 12923.9 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
Con S gp140 CFI measured at Month 6.5
|
417.6 Net MFI
Interval 213.3 to 621.9
|
—
|
—
|
—
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
Du156_D11gp120.avi/293F measured at Month 6.5
|
55.6 Net MFI
Interval 28.3 to 82.9
|
—
|
—
|
—
|
22000 Net MFI
Interval 20249.4 to 22000.0
|
22000 Net MFI
Interval 20090.5 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
TV1c8_D11gp120.avi/293F measured at Month 6.5
|
113.9 Net MFI
Interval 57.4 to 170.3
|
—
|
—
|
—
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp41 measured at Month 6.5
|
1415.2 Net MFI
Interval 1396.4 to 1434.1
|
—
|
—
|
—
|
11919.2 Net MFI
Interval 9853.8 to 16697.5
|
22000 Net MFI
Interval 22000.0 to 22000.0
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-001428.2.42 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
81.8 Net MFI
Interval 22.5 to 360.5
|
496 Net MFI
Interval 63.0 to 4034.8
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-1012.11.TC21.3257 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
344 Net MFI
Interval 13.1 to 1232.2
|
601.8 Net MFI
Interval 290.8 to 1328.8
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-1051.12.C22 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
283.2 Net MFI
Interval 1.0 to 635.9
|
399.8 Net MFI
Interval 180.2 to 3368.8
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-1394C9G1 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1375.8 Net MFI
Interval 155.2 to 7640.0
|
1141.5 Net MFI
Interval 135.1 to 10074.1
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-7060101641 V1V2 measured at Month 6.5
|
1.9 Net MFI
Interval 1.4 to 2.3
|
—
|
—
|
—
|
126.5 Net MFI
Interval 1.0 to 2443.9
|
196.6 Net MFI
Interval 123.2 to 4280.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-BF1266_431a_V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1508.5 Net MFI
Interval 19.1 to 1705.4
|
491.2 Net MFI
Interval 228.2 to 9834.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-CAP210.2.00.E8 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 222.8
|
1032.4 Net MFI
Interval 69.9 to 2225.6
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-CAP45.2.00.G3 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 556.4
|
89.9 Net MFI
Interval 8.2 to 3034.1
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-Ce1086_B2 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
262.5 Net MFI
Interval 88.2 to 6151.6
|
864.4 Net MFI
Interval 325.9 to 9912.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-Ce1176 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 18.0
|
572.9 Net MFI
Interval 13.6 to 1937.1
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-Ce704010042_2ES V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 2029.6
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-ConC V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
66.8 Net MFI
Interval 1.0 to 163.5
|
161.8 Net MFI
Interval 42.2 to 2484.6
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-Du156.12 V1V2 measured at Month 6.5
|
7.2 Net MFI
Interval 4.1 to 10.4
|
—
|
—
|
—
|
1 Net MFI
Interval 1.0 to 1.0
|
1 Net MFI
Interval 1.0 to 88.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70-TV1.21 V1V2 measured at Month 6.5
|
1 Net MFI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
863 Net MFI
Interval 214.1 to 1447.0
|
694 Net MFI
Interval 278.2 to 7141.5
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 6.5
|
71 Net MFI
Interval 71.0 to 71.0
|
—
|
—
|
—
|
623.8 Net MFI
Interval 1.0 to 2979.4
|
445.8 Net MFI
Interval 423.8 to 1988.2
|
|
Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination
gp70_CH505TF_V1V2_avi/293F measured at Month 6.5
|
286.5 Net MFI
Interval 286.5 to 286.5
|
—
|
—
|
—
|
1721.8 Net MFI
Interval 28.9 to 11673.6
|
2548 Net MFI
Interval 1283.0 to 6476.8
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI \>100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=8 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=7 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination
Clade C gp120 measured at Month 6.5
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
—
|
—
|
—
|
4.34 log10(net MFI)
Interval 4.16 to 4.34
|
4.22 log10(net MFI)
Interval 4.01 to 4.26
|
|
Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination
Clade C gp70 V1V2 measured at Month 6.5
|
2 log10(net MFI)
Interval 2.0 to 2.0
|
—
|
—
|
—
|
2.33 log10(net MFI)
Interval 2.08 to 2.56
|
2.22 log10(net MFI)
Interval 2.08 to 2.9
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=8 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=7 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination
Any Env for CD4+ T Cells, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
7 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination
Any Env for CD8+ T Cells, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
6 Participants
|
5 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination
ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
7 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination
ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
6 Participants
|
5 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination
ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
5 Participants
|
6 Participants
|
|
Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination
ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
PBMC samples were stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=8 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=7 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 2 Weeks After the Third Vaccination
Any Env for CD4+ T Cells, measured at Month 6.5
|
0.007 Percentage of cells
Interval 0.004 to 0.011
|
—
|
—
|
—
|
0.172 Percentage of cells
Interval 0.077 to 0.278
|
0.257 Percentage of cells
Interval 0.119 to 0.313
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 2 Weeks After the Third Vaccination
Any Env for CD8+ T Cells, measured at Month 6.5
|
0.002 Percentage of cells
Interval 0.001 to 0.002
|
—
|
—
|
—
|
0.067 Percentage of cells
Interval 0.038 to 0.113
|
0.094 Percentage of cells
Interval 0.041 to 0.25
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 2 Weeks After the Third Vaccination
ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5
|
0.007 Percentage of cells
Interval 0.004 to 0.011
|
—
|
—
|
—
|
0.1 Percentage of cells
Interval 0.068 to 0.166
|
0.158 Percentage of cells
Interval 0.081 to 0.195
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 2 Weeks After the Third Vaccination
ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5
|
0.002 Percentage of cells
Interval 0.001 to 0.002
|
—
|
—
|
—
|
0.059 Percentage of cells
Interval 0.027 to 0.078
|
0.065 Percentage of cells
Interval 0.026 to 0.118
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 2 Weeks After the Third Vaccination
ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5
|
0.001 Percentage of cells
Interval 0.001 to 0.001
|
—
|
—
|
—
|
0.072 Percentage of cells
Interval 0.014 to 0.095
|
0.071 Percentage of cells
Interval 0.051 to 0.132
|
|
Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 2 Weeks After the Third Vaccination
ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5
|
0.001 Percentage of cells
Interval 0.001 to 0.001
|
—
|
—
|
—
|
0.012 Percentage of cells
Interval 0.007 to 0.036
|
0.03 Percentage of cells
Interval 0.015 to 0.085
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria.
Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10.
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=8 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=7 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
CH505TF at dilution 50, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
CH505TF at dilution 80, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
DU172.17 at dilution 50, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
DU172.17 at dilution 80, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
Du422.1 at dilution 50, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
Du422.1 at dilution 80, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
MW965.26 at dilution 50, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
|
Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
MW965.26 at dilution 80, measured at Month 6.5
|
0 Participants
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 for Part BPopulation: Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria
Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only).
Outcome measures
| Measure |
Part A, Group 3: Placebo
n=2 Participants
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part A, Group 1: Vaccine
n=8 Participants
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=7 Participants
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
|---|---|---|---|---|---|---|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
CH505TF at dilution 50, measured at Month 6.5
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 8.2
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
CH505TF at dilution 80, measured at Month 6.5
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
DU172.17 at dilution 50, measured at Month 6.5
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 7.9
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
DU172.17 at dilution 80, measured at Month 6.5
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
Du422.1 at dilution 50, measured at Month 6.5
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
Du422.1 at dilution 80, measured at Month 6.5
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
5 titer
Interval 5.0 to 5.0
|
5 titer
Interval 5.0 to 5.0
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
MW965.26 at dilution 50, measured at Month 6.5
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
2298.1 titer
Interval 898.4 to 3121.5
|
418.7 titer
Interval 102.2 to 1335.6
|
|
Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination
MW965.26 at dilution 80, measured at Month 6.5
|
5 titer
Interval 5.0 to 5.0
|
—
|
—
|
—
|
757.6 titer
Interval 149.0 to 1145.8
|
104.5 titer
Interval 31.1 to 350.7
|
Adverse Events
Part A, Group 1: Vaccine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A, Group 2: Vaccine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A, Group 3: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B, Group 4: Vaccine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B, Group 5: Vaccine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part B, Group 6: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Group 1: Vaccine
n=5 participants at risk
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 participants at risk
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 3: Placebo
n=2 participants at risk
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 participants at risk
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 participants at risk
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 participants at risk
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
Other adverse events
| Measure |
Part A, Group 1: Vaccine
n=5 participants at risk
AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 2: Vaccine
n=5 participants at risk
AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0
|
Part A, Group 3: Placebo
n=2 participants at risk
Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
Part B, Group 4: Vaccine
n=10 participants at risk
AdC6-HIVgp140 5 x 10\^10 vp at Month 0 and AdC7-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 5: Vaccine
n=10 participants at risk
AdC7-HIVgp140 5 x 10\^10 vp at Month 0 and AdC6-HIVgp140 5 x 10\^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
|
Part B, Group 6: Placebo
n=2 participants at risk
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Any Event in SOC
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
50.0%
1/2 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
50.0%
1/2 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
General disorders
Any Event in SOC
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Infections and infestations
Any Event in SOC
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
20.0%
1/5 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
50.0%
5/10 • Number of events 6 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Infections and infestations
Body tinea
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Infections and infestations
Breast abscess
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
20.0%
1/5 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Infections and infestations
Urethritis
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
30.0%
3/10 • Number of events 3 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Investigations
Any Event in SOC
|
20.0%
1/5 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Investigations
Blood pressure increased
|
20.0%
1/5 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Renal and urinary disorders
Any Event in SOC
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Reproductive system and breast disorders
Any Event in SOC
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/5 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
10.0%
1/10 • Number of events 1 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/10 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
0.00%
0/2 • All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place