Trial Outcomes & Findings for Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine (NCT NCT03284710)
NCT ID: NCT03284710
Last Updated: 2024-09-19
Results Overview
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Measured at Month 6.5
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
36
|
24
|
|
Overall Study
Month 6.5 Immunogenicity Timepoint
|
31
|
31
|
31
|
18
|
|
Overall Study
Month 12 Immunogenicity Timepoint
|
30
|
31
|
31
|
17
|
|
Overall Study
Month 12.5 Immunogenicity Timepoint
|
0
|
0
|
0
|
0
|
|
Overall Study
Month 18 Immunogenicity Timepoint
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
30
|
31
|
32
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
4
|
8
|
Reasons for withdrawal
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant Unable to Adhere to Visit Schedule
|
1
|
0
|
0
|
1
|
|
Overall Study
HIV Infection
|
0
|
2
|
2
|
1
|
Baseline Characteristics
Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine
Baseline characteristics by cohort
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24 years
n=5 Participants
|
25 years
n=7 Participants
|
25 years
n=5 Participants
|
25 years
n=4 Participants
|
25 years
n=21 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
18 - 20 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Age, Customized
21 - 30 years
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Age, Customized
31 - 40 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Region of Enrollment
Mozambique
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Region of Enrollment
Zimbabwe
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: Overall Number of Participants Analyzed represents the HIV uninfected participants with specimens at Month 6.5. "Number Analyzed" shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
1086C_D7gp120.avi/293F
|
29 Participants
|
26 Participants
|
—
|
—
|
|
Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
96ZM651.D11gp120.avi
|
27 Participants
|
27 Participants
|
—
|
—
|
|
Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
TV1c8_D11gp120.avi/293F
|
29 Participants
|
27 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" represents the HIV uninfected participants with specimens at Month 6.5. "Number Analyzed" shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=27 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
1086C_D7gp120.avi/293F
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
—
|
—
|
|
Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
96ZM651.D11gp120.avi
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
—
|
—
|
|
Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
TV1c8_D11gp120.avi/293F
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" represents the HIV uninfected participants with specimens at Month 6.5. "Number Analyzed" shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=26 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
1086C_D7gp120.avi/293F
|
22 Participants
|
27 Participants
|
—
|
—
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
96ZM651.D11gp120.avi
|
12 Participants
|
22 Participants
|
—
|
—
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
TV1c8_D11gp120.avi/293F
|
18 Participants
|
27 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" represents the HIV uninfected participants with specimens at Month 6.5. "Number Analyzed" shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=22 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=27 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
1086C_D7gp120.avi/293F
|
22000 relative fluorescence units
Interval 17472.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
96ZM651.D11gp120.avi
|
8047.1 relative fluorescence units
Interval 6816.6 to 13252.6
|
7595.5 relative fluorescence units
Interval 5318.3 to 13822.1
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
TV1c8_D11gp120.avi/293F
|
8312.8 relative fluorescence units
Interval 3759.4 to 19844.6
|
12210.8 relative fluorescence units
Interval 6345.9 to 22000.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12Graded 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 |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · None
|
20 Participants
|
20 Participants
|
25 Participants
|
16 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Mild
|
16 Participants
|
15 Participants
|
11 Participants
|
8 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · None
|
21 Participants
|
20 Participants
|
22 Participants
|
17 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Mild
|
14 Participants
|
13 Participants
|
13 Participants
|
7 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Moderate
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · None
|
18 Participants
|
15 Participants
|
21 Participants
|
14 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Mild
|
17 Participants
|
18 Participants
|
14 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Moderate
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12Graded 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 |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · None
|
30 Participants
|
31 Participants
|
33 Participants
|
22 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Not gradable
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · None
|
29 Participants
|
28 Participants
|
34 Participants
|
19 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Not gradable
|
2 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Moderate
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
28 Participants
|
27 Participants
|
32 Participants
|
18 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Not gradable
|
3 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Moderate
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
4 Participants
|
7 Participants
|
6 Participants
|
3 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
0 Participants
|
2 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
34 Participants
|
34 Participants
|
34 Participants
|
24 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
23 Participants
|
23 Participants
|
25 Participants
|
17 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
13 Participants
|
11 Participants
|
11 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
0 Participants
|
2 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
36 Participants
|
31 Participants
|
35 Participants
|
24 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
1 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
32 Participants
|
28 Participants
|
30 Participants
|
21 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
0 Participants
|
1 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
36 Participants
|
35 Participants
|
35 Participants
|
22 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
28 Participants
|
28 Participants
|
29 Participants
|
19 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
8 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
30 Participants
|
34 Participants
|
32 Participants
|
23 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
6 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
36 Participants
|
35 Participants
|
36 Participants
|
24 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
36 Participants
|
34 Participants
|
33 Participants
|
23 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Related
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Not Related
|
27 Participants
|
26 Participants
|
26 Participants
|
15 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
No AE Reported
|
8 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Moderate
|
18 Participants
|
16 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Severe
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Mild
|
5 Participants
|
7 Participants
|
12 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Potentially Life-Threatening
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
No AE Reported
|
8 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 18Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
No
|
27 Participants
|
28 Participants
|
26 Participants
|
14 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
No AE Reported
|
8 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 18There were no adverse events of special interest reported by any participant.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 18New chronic conditions are adverse events that require medical intervention for \>= 30 days.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days)
Yes
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days)
No
|
28 Participants
|
27 Participants
|
26 Participants
|
13 Participants
|
|
Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days)
No AE Reported
|
8 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, Days 7, 42, 98, 182, 378, and 455Population: "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
Alkaline Phosphatase (U/L)- Day42
|
70 U/L
Interval 57.0 to 84.0
|
71.5 U/L
Interval 60.0 to 83.0
|
70.5 U/L
Interval 62.0 to 90.0
|
78 U/L
Interval 64.0 to 89.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
Alkaline Phosphatase (U/L)- Day98
|
67.5 U/L
Interval 60.0 to 79.0
|
64 U/L
Interval 54.0 to 84.0
|
—
|
77 U/L
Interval 62.0 to 87.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
Alkaline Phosphatase (U/L)- Day182
|
70 U/L
Interval 58.0 to 85.0
|
64 U/L
Interval 56.0 to 78.0
|
70 U/L
Interval 58.0 to 88.0
|
77.5 U/L
Interval 61.0 to 84.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
Alkaline Phosphatase (U/L)- Screening
|
72 U/L
Interval 59.0 to 87.0
|
70 U/L
Interval 62.0 to 89.0
|
76 U/L
Interval 63.5 to 90.5
|
79.5 U/L
Interval 65.5 to 94.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
Alkaline Phosphatase (U/L)- Day7
|
66.5 U/L
Interval 58.0 to 83.0
|
68 U/L
Interval 57.0 to 85.0
|
70 U/L
Interval 62.0 to 82.0
|
75.5 U/L
Interval 58.0 to 84.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
Alkaline Phosphatase (U/L)- Day378
|
70 U/L
Interval 58.5 to 82.5
|
65 U/L
Interval 54.0 to 83.0
|
73 U/L
Interval 68.0 to 89.0
|
77.5 U/L
Interval 55.0 to 95.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
Alkaline Phosphatase (U/L)- Day455
|
71.5 U/L
Interval 59.0 to 82.0
|
65 U/L
Interval 54.0 to 81.0
|
71.5 U/L
Interval 64.0 to 89.5
|
76.5 U/L
Interval 66.0 to 89.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
AST (U/L)- Screening
|
19 U/L
Interval 16.5 to 22.0
|
20 U/L
Interval 17.5 to 24.0
|
21.5 U/L
Interval 19.0 to 24.5
|
17 U/L
Interval 16.5 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
AST (U/L)- Day7
|
18 U/L
Interval 16.5 to 23.0
|
20 U/L
Interval 17.0 to 22.0
|
21 U/L
Interval 18.0 to 23.0
|
19 U/L
Interval 16.0 to 20.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
AST (U/L)- Day42
|
19 U/L
Interval 15.0 to 25.0
|
21 U/L
Interval 17.0 to 26.0
|
21 U/L
Interval 18.0 to 24.0
|
21 U/L
Interval 17.0 to 25.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
AST (U/L)- Day98
|
21 U/L
Interval 16.0 to 23.5
|
20 U/L
Interval 17.0 to 27.0
|
—
|
20 U/L
Interval 18.0 to 27.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
AST (U/L)- Day182
|
20 U/L
Interval 18.0 to 24.0
|
21 U/L
Interval 18.0 to 25.0
|
21 U/L
Interval 19.0 to 26.0
|
18.5 U/L
Interval 16.0 to 26.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
AST (U/L)- Day378
|
20 U/L
Interval 16.5 to 27.0
|
19 U/L
Interval 18.0 to 23.0
|
22 U/L
Interval 19.0 to 29.0
|
21.5 U/L
Interval 18.0 to 25.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
AST (U/L)- Day455
|
22.5 U/L
Interval 17.0 to 26.0
|
20 U/L
Interval 17.0 to 24.0
|
21 U/L
Interval 18.5 to 26.0
|
19 U/L
Interval 16.0 to 27.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
ALT (SGPT) (U/L)- Screening
|
15 U/L
Interval 13.0 to 19.0
|
15 U/L
Interval 11.0 to 20.5
|
16.5 U/L
Interval 13.5 to 21.5
|
14.5 U/L
Interval 12.0 to 20.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
ALT (SGPT) (U/L)- Day7
|
15.5 U/L
Interval 12.0 to 19.5
|
16 U/L
Interval 12.0 to 19.0
|
15 U/L
Interval 11.0 to 19.0
|
15.5 U/L
Interval 11.0 to 20.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
ALT (SGPT) (U/L)- Day42
|
16 U/L
Interval 12.0 to 19.0
|
18.5 U/L
Interval 11.0 to 25.0
|
15 U/L
Interval 12.0 to 18.0
|
17.5 U/L
Interval 12.0 to 22.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
ALT (SGPT) (U/L)- Day98
|
16 U/L
Interval 13.0 to 20.0
|
15 U/L
Interval 11.0 to 23.0
|
—
|
17 U/L
Interval 12.0 to 19.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
ALT (SGPT) (U/L)- Day182
|
18 U/L
Interval 13.0 to 20.0
|
16.5 U/L
Interval 13.0 to 23.0
|
15 U/L
Interval 12.0 to 23.0
|
15 U/L
Interval 11.0 to 22.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
ALT (SGPT) (U/L)- Day378
|
16 U/L
Interval 13.0 to 19.5
|
16 U/L
Interval 11.0 to 24.0
|
15 U/L
Interval 12.0 to 24.0
|
19 U/L
Interval 12.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
ALT (SGPT) (U/L)- Day455
|
16 U/L
Interval 14.0 to 20.0
|
16 U/L
Interval 13.0 to 22.0
|
16 U/L
Interval 11.0 to 21.0
|
15 U/L
Interval 12.0 to 22.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 7, 42, 98, 182, 378, and 455Population: "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (g/dL)- Screening
|
0.00071 g/dL
Interval 0.0006 to 0.00082
|
0.0007 g/dL
Interval 0.000605 to 0.000805
|
0.000705 g/dL
Interval 0.00061 to 0.00084
|
0.0007 g/dL
Interval 0.0006 to 0.0008
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (g/dL)- Day7
|
0.00071 g/dL
Interval 0.000675 to 0.000845
|
0.0007 g/dL
Interval 0.0006 to 0.0008
|
0.0007 g/dL
Interval 0.00063 to 0.0008
|
0.00075 g/dL
Interval 0.0006 to 0.0008
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (g/dL)- Day42
|
0.00071 g/dL
Interval 0.00064 to 0.0008
|
0.0007 g/dL
Interval 0.00068 to 0.0008
|
0.0007 g/dL
Interval 0.00063 to 0.0008
|
0.00071 g/dL
Interval 0.0007 to 0.0008
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (g/dL)- Day98
|
0.000705 g/dL
Interval 0.000615 to 0.00088
|
0.0008 g/dL
Interval 0.0007 to 0.00085
|
—
|
0.00072 g/dL
Interval 0.0007 to 0.0008
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (g/dL)- Day182
|
0.00073 g/dL
Interval 0.00064 to 0.0009
|
0.000715 g/dL
Interval 0.00068 to 0.0009
|
0.00078 g/dL
Interval 0.00067 to 0.00088
|
0.00077 g/dL
Interval 0.0007 to 0.0009
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (g/dL)- Day378
|
0.00079 g/dL
Interval 0.0007 to 0.00088
|
0.00076 g/dL
Interval 0.0007 to 0.00084
|
0.0007 g/dL
Interval 0.000645 to 0.000835
|
0.0007 g/dL
Interval 0.00063 to 0.0008
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (g/dL)- Day455
|
0.000795 g/dL
Interval 0.00067 to 0.0009
|
0.00074 g/dL
Interval 0.0007 to 0.0009
|
0.00071 g/dL
Interval 0.000605 to 0.000835
|
0.0007 g/dL
Interval 0.00063 to 0.0009
|
PRIMARY outcome
Timeframe: Measured during screening, Days 7, 42, 98, 182, 378, and 455Population: "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Day455
|
13.6 g/dL
Interval 12.6 to 14.3
|
13.8 g/dL
Interval 12.9 to 14.4
|
12.75 g/dL
Interval 12.0 to 14.6
|
13.6 g/dL
Interval 12.7 to 14.5
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Screening
|
13.75 g/dL
Interval 13.15 to 14.9
|
13.95 g/dL
Interval 12.9 to 15.2
|
13.85 g/dL
Interval 13.3 to 15.5
|
14.05 g/dL
Interval 13.25 to 14.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Day7
|
13.5 g/dL
Interval 12.3 to 14.4
|
13.5 g/dL
Interval 12.0 to 14.3
|
13.4 g/dL
Interval 12.4 to 14.7
|
13.5 g/dL
Interval 12.4 to 14.5
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Day42
|
13.7 g/dL
Interval 12.8 to 14.4
|
13.55 g/dL
Interval 12.8 to 14.5
|
13.65 g/dL
Interval 12.5 to 15.0
|
13.65 g/dL
Interval 12.9 to 14.7
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Day98
|
13.35 g/dL
Interval 12.25 to 14.3
|
13.6 g/dL
Interval 12.0 to 14.3
|
—
|
13.2 g/dL
Interval 12.5 to 13.7
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Day182
|
13.4 g/dL
Interval 12.4 to 14.1
|
13.5 g/dL
Interval 12.6 to 14.5
|
13.75 g/dL
Interval 12.2 to 14.9
|
13.25 g/dL
Interval 12.6 to 14.8
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Day378
|
13.3 g/dL
Interval 12.45 to 14.05
|
13.5 g/dL
Interval 12.0 to 14.0
|
13.2 g/dL
Interval 11.8 to 14.4
|
13.3 g/dL
Interval 12.7 to 14.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455Population: "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day0
|
—
|
—
|
2.0755 thousand cells/cubic mm
Interval 1.66 to 2.283
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day1
|
—
|
—
|
1.982 thousand cells/cubic mm
Interval 1.73 to 2.078
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Screening
|
2.1395 thousand cells/cubic mm
Interval 1.7555 to 2.5785
|
2.095 thousand cells/cubic mm
Interval 1.777 to 2.396
|
2.01 thousand cells/cubic mm
Interval 1.6825 to 2.461
|
2.341 thousand cells/cubic mm
Interval 2.0555 to 2.634
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day3
|
—
|
—
|
1.96 thousand cells/cubic mm
Interval 1.547 to 2.166
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day7
|
1.883 thousand cells/cubic mm
Interval 1.6385 to 2.3735
|
1.93 thousand cells/cubic mm
Interval 1.752 to 2.22
|
1.976 thousand cells/cubic mm
Interval 1.622 to 2.445
|
2.2185 thousand cells/cubic mm
Interval 1.738 to 2.571
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day42
|
1.76 thousand cells/cubic mm
Interval 1.594 to 2.13
|
1.8915 thousand cells/cubic mm
Interval 1.627 to 2.204
|
1.9915 thousand cells/cubic mm
Interval 1.54 to 2.373
|
2.1375 thousand cells/cubic mm
Interval 1.735 to 2.55
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day84
|
1.891 thousand cells/cubic mm
Interval 1.726 to 2.179
|
1.919 thousand cells/cubic mm
Interval 1.624 to 2.29
|
1.99 thousand cells/cubic mm
Interval 1.42 to 2.042
|
2.035 thousand cells/cubic mm
Interval 1.75 to 2.298
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day85
|
1.646 thousand cells/cubic mm
Interval 1.327 to 2.119
|
1.7245 thousand cells/cubic mm
Interval 1.4675 to 2.003
|
—
|
2.024 thousand cells/cubic mm
Interval 1.763 to 2.589
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day87
|
1.8725 thousand cells/cubic mm
Interval 1.418 to 2.648
|
1.83 thousand cells/cubic mm
Interval 1.659 to 2.157
|
—
|
2.076 thousand cells/cubic mm
Interval 1.471 to 2.21
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day91
|
1.8455 thousand cells/cubic mm
Interval 1.522 to 2.302
|
2.02 thousand cells/cubic mm
Interval 1.6795 to 2.36
|
—
|
2.036 thousand cells/cubic mm
Interval 1.668 to 2.253
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day98
|
1.7605 thousand cells/cubic mm
Interval 1.58 to 2.291
|
1.89 thousand cells/cubic mm
Interval 1.601 to 2.247
|
—
|
2.085 thousand cells/cubic mm
Interval 1.642 to 2.323
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day182
|
1.969 thousand cells/cubic mm
Interval 1.627 to 2.32
|
1.9905 thousand cells/cubic mm
Interval 1.578 to 2.437
|
1.797 thousand cells/cubic mm
Interval 1.481 to 2.17
|
1.9615 thousand cells/cubic mm
Interval 1.751 to 2.263
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day378
|
1.7105 thousand cells/cubic mm
Interval 1.487 to 2.102
|
1.859 thousand cells/cubic mm
Interval 1.643 to 2.202
|
1.871 thousand cells/cubic mm
Interval 1.543 to 2.211
|
2.0975 thousand cells/cubic mm
Interval 1.608 to 2.321
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)- Day455
|
1.753 thousand cells/cubic mm
Interval 1.537 to 2.162
|
1.77 thousand cells/cubic mm
Interval 1.51 to 2.087
|
1.9 thousand cells/cubic mm
Interval 1.4515 to 2.1575
|
1.977 thousand cells/cubic mm
Interval 1.548 to 2.22
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Screening
|
2.9315 thousand cells/cubic mm
Interval 2.29 to 5.254
|
2.9575 thousand cells/cubic mm
Interval 2.154 to 4.3915
|
2.986 thousand cells/cubic mm
Interval 1.88 to 3.7035
|
3.2245 thousand cells/cubic mm
Interval 2.311 to 4.0635
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day0
|
—
|
—
|
3.1935 thousand cells/cubic mm
Interval 2.207 to 3.928
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day1
|
—
|
—
|
4.482 thousand cells/cubic mm
Interval 3.854 to 5.877
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day3
|
—
|
—
|
2.82 thousand cells/cubic mm
Interval 2.218 to 4.488
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day7
|
2.903 thousand cells/cubic mm
Interval 2.196 to 4.0295
|
2.84 thousand cells/cubic mm
Interval 2.46 to 4.201
|
2.567 thousand cells/cubic mm
Interval 1.9935 to 3.268
|
2.5425 thousand cells/cubic mm
Interval 2.292 to 3.45
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day42
|
2.687 thousand cells/cubic mm
Interval 1.863 to 3.2
|
2.9545 thousand cells/cubic mm
Interval 2.246 to 3.605
|
2.6145 thousand cells/cubic mm
Interval 1.761 to 3.142
|
2.679 thousand cells/cubic mm
Interval 2.02 to 3.412
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day84
|
3.065 thousand cells/cubic mm
Interval 1.953 to 5.112
|
3.82 thousand cells/cubic mm
Interval 2.521 to 4.914
|
1.739 thousand cells/cubic mm
Interval 1.56 to 1.806
|
3.114 thousand cells/cubic mm
Interval 2.024 to 3.748
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day85
|
4.224 thousand cells/cubic mm
Interval 3.41 to 5.2045
|
5.1475 thousand cells/cubic mm
Interval 3.9985 to 6.6755
|
—
|
3.355 thousand cells/cubic mm
Interval 2.415 to 3.872
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day87
|
2.798 thousand cells/cubic mm
Interval 1.794 to 4.522
|
3.214 thousand cells/cubic mm
Interval 2.66 to 4.71
|
—
|
2.352 thousand cells/cubic mm
Interval 1.868 to 3.389
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day91
|
3.34 thousand cells/cubic mm
Interval 2.42 to 4.598
|
3.65 thousand cells/cubic mm
Interval 3.096 to 4.8395
|
—
|
3.407 thousand cells/cubic mm
Interval 2.084 to 3.667
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day98
|
2.4375 thousand cells/cubic mm
Interval 1.6465 to 3.898
|
2.814 thousand cells/cubic mm
Interval 1.841 to 3.51
|
—
|
2.94 thousand cells/cubic mm
Interval 2.157 to 3.657
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day182
|
2.734 thousand cells/cubic mm
Interval 1.83 to 3.304
|
2.4915 thousand cells/cubic mm
Interval 1.811 to 3.812
|
2.3075 thousand cells/cubic mm
Interval 1.78 to 2.844
|
2.6895 thousand cells/cubic mm
Interval 2.324 to 3.412
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day378
|
2.6995 thousand cells/cubic mm
Interval 2.0775 to 3.781
|
2.535 thousand cells/cubic mm
Interval 1.92 to 3.34
|
2.292 thousand cells/cubic mm
Interval 1.913 to 3.248
|
2.811 thousand cells/cubic mm
Interval 2.13 to 3.41
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)- Day455
|
2.5 thousand cells/cubic mm
Interval 1.837 to 3.342
|
2.282 thousand cells/cubic mm
Interval 1.748 to 3.921
|
2.2415 thousand cells/cubic mm
Interval 1.77 to 3.1005
|
2.2905 thousand cells/cubic mm
Interval 1.769 to 3.08
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455Population: "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Screening
|
5.805 thousand cells/cubic mm
Interval 5.015 to 8.18
|
5.5 thousand cells/cubic mm
Interval 4.83 to 6.97
|
5.575 thousand cells/cubic mm
Interval 4.23 to 6.57
|
6.415 thousand cells/cubic mm
Interval 5.525 to 7.3
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day0
|
—
|
—
|
5.67 thousand cells/cubic mm
Interval 4.53 to 7.23
|
—
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day1
|
—
|
—
|
7.18 thousand cells/cubic mm
Interval 6.49 to 8.53
|
—
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day3
|
—
|
—
|
5.74 thousand cells/cubic mm
Interval 4.51 to 7.04
|
—
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day42
|
4.89 thousand cells/cubic mm
Interval 4.02 to 6.64
|
5.3 thousand cells/cubic mm
Interval 4.63 to 6.09
|
5.05 thousand cells/cubic mm
Interval 4.38 to 6.12
|
5.31 thousand cells/cubic mm
Interval 4.09 to 6.17
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day84
|
5.66 thousand cells/cubic mm
Interval 4.19 to 7.33
|
5.95 thousand cells/cubic mm
Interval 5.13 to 7.73
|
4.21 thousand cells/cubic mm
Interval 3.86 to 4.48
|
5.42 thousand cells/cubic mm
Interval 4.79 to 6.53
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day85
|
6.965 thousand cells/cubic mm
Interval 5.62 to 7.535
|
7.685 thousand cells/cubic mm
Interval 6.38 to 9.15
|
—
|
5.8 thousand cells/cubic mm
Interval 4.97 to 7.17
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day42
|
267 thousand cells/cubic mm
Interval 226.0 to 318.0
|
277 thousand cells/cubic mm
Interval 238.0 to 307.0
|
256 thousand cells/cubic mm
Interval 230.0 to 321.0
|
257.5 thousand cells/cubic mm
Interval 244.0 to 302.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day182
|
282 thousand cells/cubic mm
Interval 239.0 to 306.0
|
272 thousand cells/cubic mm
Interval 234.0 to 322.0
|
245.5 thousand cells/cubic mm
Interval 222.0 to 287.0
|
256 thousand cells/cubic mm
Interval 238.0 to 308.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day378
|
274 thousand cells/cubic mm
Interval 243.5 to 316.5
|
282 thousand cells/cubic mm
Interval 245.0 to 318.0
|
262 thousand cells/cubic mm
Interval 241.0 to 314.0
|
275.5 thousand cells/cubic mm
Interval 237.0 to 323.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day7
|
5.5 thousand cells/cubic mm
Interval 4.49 to 7.07
|
5.56 thousand cells/cubic mm
Interval 4.88 to 6.69
|
5.275 thousand cells/cubic mm
Interval 4.24 to 6.005
|
5.36 thousand cells/cubic mm
Interval 4.43 to 6.64
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day87
|
5.55 thousand cells/cubic mm
Interval 3.58 to 7.92
|
5.84 thousand cells/cubic mm
Interval 5.31 to 7.38
|
—
|
4.88 thousand cells/cubic mm
Interval 4.2 to 6.53
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day91
|
6.39 thousand cells/cubic mm
Interval 4.35 to 8.8
|
6.585 thousand cells/cubic mm
Interval 5.275 to 7.03
|
—
|
5.305 thousand cells/cubic mm
Interval 4.57 to 6.85
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day98
|
4.935 thousand cells/cubic mm
Interval 3.945 to 6.65
|
5.22 thousand cells/cubic mm
Interval 4.54 to 6.18
|
—
|
5.5 thousand cells/cubic mm
Interval 4.52 to 6.29
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day182
|
5.17 thousand cells/cubic mm
Interval 4.22 to 6.61
|
5 thousand cells/cubic mm
Interval 4.4 to 6.06
|
4.895 thousand cells/cubic mm
Interval 4.19 to 5.98
|
5.405 thousand cells/cubic mm
Interval 4.64 to 6.66
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day378
|
5.37 thousand cells/cubic mm
Interval 4.265 to 5.895
|
5.05 thousand cells/cubic mm
Interval 4.07 to 5.75
|
5.06 thousand cells/cubic mm
Interval 4.08 to 6.03
|
5.67 thousand cells/cubic mm
Interval 4.62 to 6.06
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
WBC (1000/cubic mm)- Day455
|
4.795 thousand cells/cubic mm
Interval 3.55 to 6.61
|
4.62 thousand cells/cubic mm
Interval 3.78 to 6.33
|
4.565 thousand cells/cubic mm
Interval 4.035 to 5.675
|
4.745 thousand cells/cubic mm
Interval 3.96 to 5.93
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Screening
|
269.5 thousand cells/cubic mm
Interval 232.5 to 321.5
|
269.5 thousand cells/cubic mm
Interval 226.5 to 301.5
|
255.5 thousand cells/cubic mm
Interval 224.5 to 298.5
|
260.5 thousand cells/cubic mm
Interval 236.0 to 307.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day0
|
—
|
—
|
269 thousand cells/cubic mm
Interval 234.0 to 307.0
|
—
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day1
|
—
|
—
|
252 thousand cells/cubic mm
Interval 232.0 to 292.0
|
—
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day3
|
—
|
—
|
242 thousand cells/cubic mm
Interval 224.0 to 282.0
|
—
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day7
|
269.5 thousand cells/cubic mm
Interval 234.5 to 309.0
|
286 thousand cells/cubic mm
Interval 232.0 to 305.0
|
256 thousand cells/cubic mm
Interval 220.0 to 292.0
|
286 thousand cells/cubic mm
Interval 239.0 to 306.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day84
|
277 thousand cells/cubic mm
Interval 251.0 to 311.0
|
261 thousand cells/cubic mm
Interval 218.0 to 320.0
|
189 thousand cells/cubic mm
Interval 126.0 to 250.0
|
271 thousand cells/cubic mm
Interval 228.0 to 334.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day85
|
272.5 thousand cells/cubic mm
Interval 244.0 to 323.5
|
281 thousand cells/cubic mm
Interval 237.5 to 318.5
|
—
|
272 thousand cells/cubic mm
Interval 215.0 to 309.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day87
|
283 thousand cells/cubic mm
Interval 241.0 to 320.0
|
273 thousand cells/cubic mm
Interval 237.0 to 319.0
|
—
|
265 thousand cells/cubic mm
Interval 235.0 to 299.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day91
|
286 thousand cells/cubic mm
Interval 241.0 to 339.0
|
279.5 thousand cells/cubic mm
Interval 256.5 to 309.5
|
—
|
289.5 thousand cells/cubic mm
Interval 245.0 to 315.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day98
|
260 thousand cells/cubic mm
Interval 235.5 to 317.0
|
256 thousand cells/cubic mm
Interval 232.0 to 326.0
|
—
|
276 thousand cells/cubic mm
Interval 231.0 to 321.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Platelets (1000/cubic mm)- Day455
|
265.5 thousand cells/cubic mm
Interval 220.0 to 308.0
|
275 thousand cells/cubic mm
Interval 233.0 to 292.0
|
262 thousand cells/cubic mm
Interval 219.0 to 292.5
|
259 thousand cells/cubic mm
Interval 223.0 to 273.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455Population: "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment arm for each post-vaccination time point.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day85
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day87
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day378
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
AST (U/L)- Day7
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
AST (U/L)- Day42
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
AST (U/L)- Day98
|
1 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
AST (U/L)- Day182
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
AST (U/L)- Day378
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
ALT (SGPT) (U/L)- Day7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
ALT (SGPT) (U/L)- Day42
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
ALT (SGPT) (U/L)- Day84
|
—
|
—
|
1 Participants
|
—
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
ALT (SGPT) (U/L)- Day98
|
1 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
ALT (SGPT) (U/L)- Day182
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
ALT (SGPT) (U/L)- Day378
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day42
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day84
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day91
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day98
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day182
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day378
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day455
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day7
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day42
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day84
|
1 Participants
|
—
|
—
|
—
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day98
|
4 Participants
|
4 Participants
|
—
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day182
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day455
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Platelets (1000/cubic mm)- Day7
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Platelets (1000/cubic mm)- Day42
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Platelets (1000/cubic mm)- Day182
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Neutrophils (1000/cubic mm)- Day91
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Neutrophils (1000/cubic mm)- Day98
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Neutrophils (1000/cubic mm)- Day182
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Neutrophils (1000/cubic mm)- Day378
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 18There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 18From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment arm.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Clinical event other than reactogenicity
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Other reason
|
4 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
No discontinuation
|
31 Participants
|
32 Participants
|
32 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 6.5 and 12.Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=33 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=17 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 6.5)
|
29 Participants
|
26 Participants
|
32 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 6.5)
|
27 Participants
|
27 Participants
|
30 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 6.5)
|
29 Participants
|
27 Participants
|
32 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 12)
|
29 Participants
|
26 Participants
|
29 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 12)
|
7 Participants
|
5 Participants
|
25 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 12)
|
25 Participants
|
22 Participants
|
29 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 6.5 and 12.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=17 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 6.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 6.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 13363.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 12)
|
6759.8 relative fluorescence units
Interval 3662.2 to 15765.5
|
11657.1 relative fluorescence units
Interval 3131.1 to 18042.6
|
22000 relative fluorescence units
Interval 13782.0 to 22000.0
|
4265.8 relative fluorescence units
Interval 2385.0 to 8666.5
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 12)
|
3182.8 relative fluorescence units
Interval 1705.4 to 4285.9
|
2167.8 relative fluorescence units
Interval 1767.5 to 2524.8
|
3000 relative fluorescence units
Interval 1871.5 to 6561.0
|
1676 relative fluorescence units
Interval 1676.0 to 1676.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 18)
|
22000 relative fluorescence units
Interval 13447.4 to 22000.0
|
22000 relative fluorescence units
Interval 17031.4 to 22000.0
|
22000 relative fluorescence units
Interval 16465.8 to 22000.0
|
16187 relative fluorescence units
Interval 8260.8 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 6.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 12)
|
1252.5 relative fluorescence units
Interval 686.0 to 3761.2
|
1660 relative fluorescence units
Interval 892.6 to 2898.4
|
10750 relative fluorescence units
Interval 5326.5 to 22000.0
|
1086 relative fluorescence units
Interval 442.6 to 2429.1
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 18)
|
6135.8 relative fluorescence units
Interval 4058.2 to 10887.0
|
5439 relative fluorescence units
Interval 2617.8 to 8736.1
|
5372.6 relative fluorescence units
Interval 3140.4 to 12123.9
|
2794 relative fluorescence units
Interval 2226.0 to 4364.1
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 18)
|
8367.6 relative fluorescence units
Interval 2745.8 to 21097.6
|
8893.4 relative fluorescence units
Interval 3450.6 to 20507.7
|
20549 relative fluorescence units
Interval 8176.7 to 22000.0
|
6794.5 relative fluorescence units
Interval 2788.2 to 9961.5
|
SECONDARY outcome
Timeframe: Measured at Months 6.5 and 12.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=33 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=17 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 6.5)
|
27 Participants
|
27 Participants
|
31 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 6.5)
|
22 Participants
|
23 Participants
|
28 Participants
|
11 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 6.5)
|
14 Participants
|
13 Participants
|
16 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 6.5)
|
26 Participants
|
26 Participants
|
29 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 6.5)
|
29 Participants
|
27 Participants
|
32 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 6.5)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 6.5)
|
8 Participants
|
13 Participants
|
19 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 6.5)
|
17 Participants
|
15 Participants
|
26 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 6.5)
|
10 Participants
|
14 Participants
|
24 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 6.5)
|
9 Participants
|
13 Participants
|
25 Participants
|
3 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 12)
|
4 Participants
|
1 Participants
|
12 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 12)
|
15 Participants
|
14 Participants
|
25 Participants
|
5 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 12)
|
4 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 12)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 12)
|
3 Participants
|
1 Participants
|
14 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 12)
|
22 Participants
|
25 Participants
|
30 Participants
|
13 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 12)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12)
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 12)
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 6.5)
|
27 Participants
|
27 Participants
|
30 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 12)
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12)
|
1 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 6.5 and 12.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=17 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 6.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 6.5)
|
—
|
4472.8 relative fluorescence units
Interval 4472.8 to 4472.8
|
—
|
—
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 6.5)
|
1476 relative fluorescence units
Interval 587.5 to 3383.0
|
1888.8 relative fluorescence units
Interval 1204.9 to 4129.0
|
6450.5 relative fluorescence units
Interval 1593.2 to 8631.6
|
406.9 relative fluorescence units
Interval 355.6 to 725.1
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 6.5)
|
1368.8 relative fluorescence units
Interval 727.0 to 3992.5
|
1292.5 relative fluorescence units
Interval 819.5 to 5713.8
|
4521.2 relative fluorescence units
Interval 1193.5 to 10484.0
|
651.8 relative fluorescence units
Interval 520.8 to 1328.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 12)
|
949 relative fluorescence units
Interval 949.0 to 949.0
|
442.5 relative fluorescence units
Interval 442.5 to 442.5
|
487.2 relative fluorescence units
Interval 283.1 to 1070.0
|
—
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 12)
|
1557.1 relative fluorescence units
Interval 919.9 to 2207.1
|
1390.2 relative fluorescence units
Interval 1390.2 to 1390.2
|
1425.8 relative fluorescence units
Interval 1151.9 to 2257.9
|
952 relative fluorescence units
Interval 952.0 to 952.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 12)
|
286.5 relative fluorescence units
Interval 199.6 to 483.8
|
318.1 relative fluorescence units
Interval 206.5 to 527.6
|
834.8 relative fluorescence units
Interval 360.0 to 1718.0
|
339.2 relative fluorescence units
Interval 169.8 to 709.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 12)
|
954 relative fluorescence units
Interval 556.6 to 2888.4
|
1599 relative fluorescence units
Interval 916.2 to 2333.5
|
6908.8 relative fluorescence units
Interval 2639.8 to 14532.9
|
680.2 relative fluorescence units
Interval 397.0 to 1169.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 12)
|
—
|
—
|
—
|
9264 relative fluorescence units
Interval 9264.0 to 9264.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 12)
|
—
|
1264.8 relative fluorescence units
Interval 1264.8 to 1264.8
|
819.9 relative fluorescence units
Interval 561.7 to 1078.1
|
—
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12)
|
495.2 relative fluorescence units
Interval 495.2 to 495.2
|
502.4 relative fluorescence units
Interval 421.6 to 583.2
|
722.4 relative fluorescence units
Interval 218.6 to 1481.9
|
2504.8 relative fluorescence units
Interval 2504.8 to 2504.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12)
|
693.8 relative fluorescence units
Interval 693.8 to 693.8
|
559.9 relative fluorescence units
Interval 490.7 to 629.1
|
427 relative fluorescence units
Interval 378.2 to 1999.4
|
—
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 12.5)
|
22000 relative fluorescence units
Interval 18877.6 to 22000.0
|
22000 relative fluorescence units
Interval 13449.4 to 22000.0
|
22000 relative fluorescence units
Interval 17787.8 to 22000.0
|
22000 relative fluorescence units
Interval 11267.2 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 12.5)
|
22000 relative fluorescence units
Interval 20752.0 to 22000.0
|
22000 relative fluorescence units
Interval 17453.4 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 16264.4 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 18)
|
1954 relative fluorescence units
Interval 1242.2 to 3022.0
|
2546.9 relative fluorescence units
Interval 1072.2 to 7260.1
|
1571 relative fluorescence units
Interval 1131.2 to 3575.8
|
1351.9 relative fluorescence units
Interval 1189.6 to 1367.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 18)
|
2373.2 relative fluorescence units
Interval 1574.0 to 4438.2
|
2805 relative fluorescence units
Interval 1459.5 to 4348.8
|
2405.5 relative fluorescence units
Interval 1517.5 to 4459.5
|
1185.2 relative fluorescence units
Interval 993.6 to 1463.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 18)
|
8793.8 relative fluorescence units
Interval 3178.8 to 16947.8
|
9031.1 relative fluorescence units
Interval 3772.2 to 22000.0
|
13261.8 relative fluorescence units
Interval 7458.2 to 22000.0
|
5032.5 relative fluorescence units
Interval 3082.0 to 9318.4
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 18)
|
163.1 relative fluorescence units
Interval 125.2 to 272.5
|
180.2 relative fluorescence units
Interval 130.4 to 208.4
|
1319.2 relative fluorescence units
Interval 605.5 to 1729.8
|
1114.2 relative fluorescence units
Interval 1114.2 to 1114.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 18)
|
244.5 relative fluorescence units
Interval 244.5 to 244.5
|
1593.8 relative fluorescence units
Interval 914.8 to 1638.4
|
1332 relative fluorescence units
Interval 425.0 to 1556.0
|
1227.5 relative fluorescence units
Interval 1227.5 to 1227.5
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 6.5)
|
18852.2 relative fluorescence units
Interval 10385.8 to 22000.0
|
11851.2 relative fluorescence units
Interval 4795.8 to 20954.4
|
22000 relative fluorescence units
Interval 19705.7 to 22000.0
|
9648.8 relative fluorescence units
Interval 4793.4 to 18959.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 6.5)
|
21481.5 relative fluorescence units
Interval 10941.0 to 22000.0
|
15307.5 relative fluorescence units
Interval 7928.9 to 22000.0
|
22000 relative fluorescence units
Interval 19518.4 to 22000.0
|
12791.2 relative fluorescence units
Interval 6158.2 to 21474.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 18)
|
314.2 relative fluorescence units
Interval 314.2 to 314.2
|
1717.6 relative fluorescence units
Interval 1210.9 to 2224.3
|
623.8 relative fluorescence units
Interval 383.3 to 886.9
|
593.2 relative fluorescence units
Interval 593.2 to 593.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 18)
|
137 relative fluorescence units
Interval 110.2 to 484.0
|
462 relative fluorescence units
Interval 371.2 to 512.5
|
362.2 relative fluorescence units
Interval 194.8 to 1003.6
|
445.9 relative fluorescence units
Interval 429.3 to 462.4
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 18)
|
1204.5 relative fluorescence units
Interval 1204.5 to 1204.5
|
1523.2 relative fluorescence units
Interval 1067.4 to 5288.9
|
821.8 relative fluorescence units
Interval 714.1 to 2419.4
|
909 relative fluorescence units
Interval 909.0 to 909.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 12)
|
2429.8 relative fluorescence units
Interval 1981.9 to 3020.2
|
1139.8 relative fluorescence units
Interval 1139.8 to 1139.8
|
1908.5 relative fluorescence units
Interval 1479.8 to 2280.8
|
2036.8 relative fluorescence units
Interval 2036.8 to 2036.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 6.5)
|
968 relative fluorescence units
Interval 745.2 to 1412.3
|
1963 relative fluorescence units
Interval 1040.5 to 4739.8
|
2631.8 relative fluorescence units
Interval 1444.0 to 6033.8
|
1219.4 relative fluorescence units
Interval 695.3 to 1835.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 6.5)
|
714.8 relative fluorescence units
Interval 386.5 to 1925.0
|
1367.5 relative fluorescence units
Interval 916.9 to 4679.8
|
6205.1 relative fluorescence units
Interval 1550.6 to 13995.4
|
727.1 relative fluorescence units
Interval 430.1 to 1152.1
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 12)
|
290.4 relative fluorescence units
Interval 226.0 to 497.6
|
237.5 relative fluorescence units
Interval 196.7 to 270.4
|
279.2 relative fluorescence units
Interval 245.8 to 309.8
|
124.2 relative fluorescence units
Interval 124.2 to 124.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 12)
|
—
|
—
|
—
|
1296.8 relative fluorescence units
Interval 1296.8 to 1296.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 12.5)
|
4553.5 relative fluorescence units
Interval 2286.2 to 9393.8
|
3313.8 relative fluorescence units
Interval 1245.9 to 10641.6
|
5728.8 relative fluorescence units
Interval 2011.8 to 10929.1
|
1034.2 relative fluorescence units
Interval 482.6 to 5401.9
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 12.5)
|
2021.2 relative fluorescence units
Interval 1142.2 to 3862.8
|
3476 relative fluorescence units
Interval 906.0 to 6288.5
|
3484.6 relative fluorescence units
Interval 994.0 to 8674.6
|
1380.2 relative fluorescence units
Interval 601.0 to 3883.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 20433.4 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 15222.2 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
1407.4 relative fluorescence units
Interval 993.3 to 3027.4
|
2057.8 relative fluorescence units
Interval 714.5 to 6260.2
|
12436.5 relative fluorescence units
Interval 1806.4 to 22000.0
|
2031.8 relative fluorescence units
Interval 1158.8 to 4055.5
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 12.5)
|
—
|
—
|
4644.8 relative fluorescence units
Interval 3651.8 to 13322.4
|
8348.5 relative fluorescence units
Interval 5951.1 to 10745.9
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12.5)
|
1213.2 relative fluorescence units
Interval 734.6 to 3588.6
|
2332.9 relative fluorescence units
Interval 732.9 to 5249.1
|
8987.2 relative fluorescence units
Interval 2613.6 to 22000.0
|
1324.4 relative fluorescence units
Interval 941.3 to 3481.6
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 12.5)
|
763.5 relative fluorescence units
Interval 670.1 to 3615.2
|
2246.5 relative fluorescence units
Interval 999.1 to 5417.9
|
8372.5 relative fluorescence units
Interval 1587.8 to 21441.9
|
2869.5 relative fluorescence units
Interval 1171.8 to 4368.3
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 12.5)
|
1427.2 relative fluorescence units
Interval 891.8 to 9947.6
|
3770.8 relative fluorescence units
Interval 1125.0 to 10077.4
|
8793.6 relative fluorescence units
Interval 1318.6 to 21615.9
|
1639.8 relative fluorescence units
Interval 1290.2 to 6055.9
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 18)
|
1106 relative fluorescence units
Interval 444.2 to 2628.0
|
1552.5 relative fluorescence units
Interval 607.0 to 3231.8
|
1853.2 relative fluorescence units
Interval 929.5 to 4194.5
|
961.5 relative fluorescence units
Interval 695.8 to 1429.6
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 18)
|
—
|
2549.2 relative fluorescence units
Interval 2549.2 to 2549.2
|
7284.8 relative fluorescence units
Interval 5785.5 to 14642.4
|
19096.5 relative fluorescence units
Interval 19096.5 to 19096.5
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 18)
|
370.8 relative fluorescence units
Interval 370.8 to 370.8
|
584 relative fluorescence units
Interval 541.4 to 872.1
|
987.8 relative fluorescence units
Interval 590.4 to 1672.9
|
2221.8 relative fluorescence units
Interval 2221.8 to 2221.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 6.5)
|
7008.2 relative fluorescence units
Interval 1079.8 to 9841.2
|
4347.5 relative fluorescence units
Interval 2171.8 to 7081.4
|
3203 relative fluorescence units
Interval 1343.1 to 10818.8
|
489 relative fluorescence units
Interval 409.5 to 2427.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 6.5)
|
1284.5 relative fluorescence units
Interval 1139.7 to 1831.6
|
954.5 relative fluorescence units
Interval 866.2 to 3260.0
|
1830.8 relative fluorescence units
Interval 1104.4 to 2254.2
|
865.6 relative fluorescence units
Interval 796.6 to 934.7
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 6.5)
|
21899.6 relative fluorescence units
Interval 11363.6 to 22000.0
|
14046.6 relative fluorescence units
Interval 9418.1 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
9978 relative fluorescence units
Interval 5492.0 to 20428.5
|
SECONDARY outcome
Timeframe: Measured at Months 6.5, 12, 12.5, and 18Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available ICS data after filtering for assay specific quality control criteria at each timepoint.
PBMC samples are 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 markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=31 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=18 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
LAI Gag (Month 6.5)
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env ZM96 (Month 12)
|
6 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-1-ZM96 (Month 12.5)
|
15 Participants
|
20 Participants
|
5 Participants
|
9 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any Env (Month 18)
|
16 Participants
|
23 Participants
|
13 Participants
|
9 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
TV1 gp120 (Month 18)
|
11 Participants
|
23 Participants
|
11 Participants
|
7 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-2-ZM96 (Month 12.5)
|
1 Participants
|
8 Participants
|
4 Participants
|
0 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
LAI Gag (Month 12.5)
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
TV1 gp120 (Month 12.5)
|
20 Participants
|
24 Participants
|
16 Participants
|
8 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
1086 gp120 (Month 18)
|
9 Participants
|
21 Participants
|
10 Participants
|
5 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any HIV (Month 18)
|
17 Participants
|
23 Participants
|
14 Participants
|
9 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env ZM96 (Month 18)
|
14 Participants
|
18 Participants
|
4 Participants
|
6 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-1-ZM96 (Month 18)
|
14 Participants
|
20 Participants
|
3 Participants
|
6 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-2-ZM96 (Month 18)
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
LAI Gag (Month 18)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
1086 gp120 (Month 6.5)
|
15 Participants
|
19 Participants
|
16 Participants
|
6 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any Env (Month 6.5)
|
16 Participants
|
20 Participants
|
21 Participants
|
8 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any HIV (Month 6.5)
|
17 Participants
|
20 Participants
|
21 Participants
|
8 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env ZM96 (Month 6.5)
|
12 Participants
|
14 Participants
|
8 Participants
|
5 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-1-ZM96 (Month 6.5)
|
12 Participants
|
15 Participants
|
7 Participants
|
5 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-2-ZM96 (Month 6.5)
|
3 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
TV1 gp120 (Month 6.5)
|
15 Participants
|
20 Participants
|
20 Participants
|
6 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
1086 gp120 (Month 12)
|
6 Participants
|
13 Participants
|
10 Participants
|
0 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any Env (Month 12)
|
9 Participants
|
16 Participants
|
13 Participants
|
5 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any HIV (Month 12)
|
10 Participants
|
16 Participants
|
14 Participants
|
5 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-1-ZM96 (Month 12)
|
6 Participants
|
9 Participants
|
4 Participants
|
5 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-2-ZM96 (Month 12)
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
LAI Gag (Month 12)
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
TV1 gp120 (Month 12)
|
8 Participants
|
17 Participants
|
13 Participants
|
2 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
1086 gp120 (Month 12.5)
|
15 Participants
|
21 Participants
|
12 Participants
|
5 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any Env (Month 12.5)
|
25 Participants
|
24 Participants
|
18 Participants
|
9 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any HIV (Month 12.5)
|
25 Participants
|
24 Participants
|
19 Participants
|
9 Participants
|
|
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env ZM96 (Month 12.5)
|
15 Participants
|
20 Participants
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 6.5, 12, 12.5, and 18Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available ICS data after filtering for assay specific quality control criteria at each timepoint.
PBMC samples are 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 markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=25 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=24 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=21 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=9 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env ZM96 (Month 18)
|
0.085 % CD4+ T-cells
Interval 0.062 to 0.132
|
0.133 % CD4+ T-cells
Interval 0.087 to 0.155
|
0.117 % CD4+ T-cells
Interval 0.114 to 0.121
|
0.133 % CD4+ T-cells
Interval 0.093 to 0.165
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any Env (Month 12.5)
|
0.172 % CD4+ T-cells
Interval 0.105 to 0.215
|
0.277 % CD4+ T-cells
Interval 0.148 to 0.472
|
0.138 % CD4+ T-cells
Interval 0.103 to 0.236
|
0.18 % CD4+ T-cells
Interval 0.096 to 0.207
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any HIV (Month 12.5)
|
0.172 % CD4+ T-cells
Interval 0.127 to 0.209
|
0.314 % CD4+ T-cells
Interval 0.165 to 0.526
|
0.148 % CD4+ T-cells
Interval 0.112 to 0.263
|
0.188 % CD4+ T-cells
Interval 0.125 to 0.252
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env ZM96 (Month 12.5)
|
0.149 % CD4+ T-cells
Interval 0.077 to 0.248
|
0.172 % CD4+ T-cells
Interval 0.124 to 0.288
|
0.202 % CD4+ T-cells
Interval 0.146 to 0.242
|
0.126 % CD4+ T-cells
Interval 0.099 to 0.201
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-1-ZM96 (Month 12.5)
|
0.14 % CD4+ T-cells
Interval 0.092 to 0.257
|
0.135 % CD4+ T-cells
Interval 0.099 to 0.183
|
0.157 % CD4+ T-cells
Interval 0.098 to 0.173
|
0.106 % CD4+ T-cells
Interval 0.096 to 0.206
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-2-ZM96 (Month 12.5)
|
0.128 % CD4+ T-cells
Interval 0.128 to 0.128
|
0.163 % CD4+ T-cells
Interval 0.087 to 0.258
|
0.084 % CD4+ T-cells
Interval 0.075 to 0.094
|
—
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
LAI Gag (Month 12.5)
|
0.11 % CD4+ T-cells
Interval 0.11 to 0.11
|
0.085 % CD4+ T-cells
Interval 0.071 to 0.099
|
0.136 % CD4+ T-cells
Interval 0.136 to 0.136
|
0.081 % CD4+ T-cells
Interval 0.081 to 0.081
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
TV1 gp120 (Month 12.5)
|
0.133 % CD4+ T-cells
Interval 0.103 to 0.228
|
0.275 % CD4+ T-cells
Interval 0.138 to 0.379
|
0.138 % CD4+ T-cells
Interval 0.112 to 0.233
|
0.147 % CD4+ T-cells
Interval 0.1 to 0.236
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
1086 gp120 (Month 18)
|
0.106 % CD4+ T-cells
Interval 0.095 to 0.126
|
0.121 % CD4+ T-cells
Interval 0.093 to 0.237
|
0.121 % CD4+ T-cells
Interval 0.099 to 0.133
|
0.107 % CD4+ T-cells
Interval 0.089 to 0.116
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any Env (Month 18)
|
0.117 % CD4+ T-cells
Interval 0.082 to 0.19
|
0.169 % CD4+ T-cells
Interval 0.096 to 0.272
|
0.122 % CD4+ T-cells
Interval 0.121 to 0.157
|
0.123 % CD4+ T-cells
Interval 0.085 to 0.164
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any HIV (Month 18)
|
0.105 % CD4+ T-cells
Interval 0.079 to 0.186
|
0.156 % CD4+ T-cells
Interval 0.115 to 0.329
|
0.129 % CD4+ T-cells
Interval 0.102 to 0.178
|
0.123 % CD4+ T-cells
Interval 0.115 to 0.187
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-1-ZM96 (Month 18)
|
0.09 % CD4+ T-cells
Interval 0.07 to 0.131
|
0.111 % CD4+ T-cells
Interval 0.078 to 0.131
|
0.077 % CD4+ T-cells
Interval 0.072 to 0.083
|
0.124 % CD4+ T-cells
Interval 0.081 to 0.14
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-2-ZM96 (Month 18)
|
—
|
0.132 % CD4+ T-cells
Interval 0.118 to 0.175
|
0.064 % CD4+ T-cells
Interval 0.055 to 0.072
|
—
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
LAI Gag (Month 18)
|
0.076 % CD4+ T-cells
Interval 0.076 to 0.076
|
0.059 % CD4+ T-cells
Interval 0.051 to 0.067
|
0.07 % CD4+ T-cells
Interval 0.07 to 0.07
|
—
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
TV1 gp120 (Month 18)
|
0.109 % CD4+ T-cells
Interval 0.084 to 0.217
|
0.158 % CD4+ T-cells
Interval 0.105 to 0.258
|
0.122 % CD4+ T-cells
Interval 0.11 to 0.168
|
0.085 % CD4+ T-cells
Interval 0.076 to 0.113
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
1086 gp120 (Month 6.5)
|
0.209 % CD4+ T-cells
Interval 0.115 to 0.259
|
0.181 % CD4+ T-cells
Interval 0.123 to 0.277
|
0.222 % CD4+ T-cells
Interval 0.08 to 0.294
|
0.124 % CD4+ T-cells
Interval 0.108 to 0.161
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any Env (Month 6.5)
|
0.216 % CD4+ T-cells
Interval 0.136 to 0.339
|
0.182 % CD4+ T-cells
Interval 0.145 to 0.407
|
0.149 % CD4+ T-cells
Interval 0.121 to 0.332
|
0.142 % CD4+ T-cells
Interval 0.115 to 0.209
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any HIV (Month 6.5)
|
0.221 % CD4+ T-cells
Interval 0.136 to 0.358
|
0.221 % CD4+ T-cells
Interval 0.158 to 0.43
|
0.202 % CD4+ T-cells
Interval 0.118 to 0.319
|
0.148 % CD4+ T-cells
Interval 0.135 to 0.291
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env ZM96 (Month 6.5)
|
0.224 % CD4+ T-cells
Interval 0.104 to 0.339
|
0.162 % CD4+ T-cells
Interval 0.142 to 0.276
|
0.237 % CD4+ T-cells
Interval 0.194 to 0.255
|
0.137 % CD4+ T-cells
Interval 0.133 to 0.262
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-1-ZM96 (Month 6.5)
|
0.186 % CD4+ T-cells
Interval 0.078 to 0.269
|
0.151 % CD4+ T-cells
Interval 0.098 to 0.233
|
0.16 % CD4+ T-cells
Interval 0.136 to 0.162
|
0.13 % CD4+ T-cells
Interval 0.117 to 0.189
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-2-ZM96 (Month 6.5)
|
0.107 % CD4+ T-cells
Interval 0.1 to 0.147
|
0.067 % CD4+ T-cells
Interval 0.059 to 0.102
|
0.097 % CD4+ T-cells
Interval 0.084 to 0.111
|
0.072 % CD4+ T-cells
Interval 0.072 to 0.072
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
LAI Gag (Month 6.5)
|
0.108 % CD4+ T-cells
Interval 0.108 to 0.108
|
—
|
0.09 % CD4+ T-cells
Interval 0.09 to 0.09
|
0.092 % CD4+ T-cells
Interval 0.082 to 0.102
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
TV1 gp120 (Month 6.5)
|
0.193 % CD4+ T-cells
Interval 0.114 to 0.258
|
0.175 % CD4+ T-cells
Interval 0.135 to 0.326
|
0.152 % CD4+ T-cells
Interval 0.11 to 0.275
|
0.132 % CD4+ T-cells
Interval 0.104 to 0.184
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
1086 gp120 (Month 12)
|
0.173 % CD4+ T-cells
Interval 0.156 to 0.199
|
0.157 % CD4+ T-cells
Interval 0.117 to 0.322
|
0.153 % CD4+ T-cells
Interval 0.127 to 0.177
|
—
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any Env (Month 12)
|
0.15 % CD4+ T-cells
Interval 0.119 to 0.286
|
0.185 % CD4+ T-cells
Interval 0.116 to 0.298
|
0.156 % CD4+ T-cells
Interval 0.095 to 0.255
|
0.124 % CD4+ T-cells
Interval 0.089 to 0.176
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Any HIV (Month 12)
|
0.149 % CD4+ T-cells
Interval 0.104 to 0.281
|
0.206 % CD4+ T-cells
Interval 0.134 to 0.317
|
0.161 % CD4+ T-cells
Interval 0.11 to 0.264
|
0.167 % CD4+ T-cells
Interval 0.124 to 0.172
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env ZM96 (Month 12)
|
0.238 % CD4+ T-cells
Interval 0.131 to 0.307
|
0.146 % CD4+ T-cells
Interval 0.13 to 0.365
|
0.157 % CD4+ T-cells
Interval 0.133 to 0.197
|
0.133 % CD4+ T-cells
Interval 0.083 to 0.178
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-1-ZM96 (Month 12)
|
0.215 % CD4+ T-cells
Interval 0.134 to 0.225
|
0.125 % CD4+ T-cells
Interval 0.092 to 0.196
|
0.085 % CD4+ T-cells
Interval 0.077 to 0.128
|
0.107 % CD4+ T-cells
Interval 0.089 to 0.17
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
Env-2-ZM96 (Month 12)
|
0.101 % CD4+ T-cells
Interval 0.101 to 0.101
|
0.113 % CD4+ T-cells
Interval 0.056 to 0.172
|
0.072 % CD4+ T-cells
Interval 0.066 to 0.077
|
—
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
LAI Gag (Month 12)
|
0.065 % CD4+ T-cells
Interval 0.065 to 0.065
|
0.053 % CD4+ T-cells
Interval 0.05 to 0.056
|
0.159 % CD4+ T-cells
Interval 0.159 to 0.159
|
0.056 % CD4+ T-cells
Interval 0.056 to 0.056
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
TV1 gp120 (Month 12)
|
0.124 % CD4+ T-cells
Interval 0.095 to 0.286
|
0.172 % CD4+ T-cells
Interval 0.109 to 0.237
|
0.118 % CD4+ T-cells
Interval 0.089 to 0.219
|
0.087 % CD4+ T-cells
Interval 0.078 to 0.097
|
|
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
1086 gp120 (Month 12.5)
|
0.118 % CD4+ T-cells
Interval 0.097 to 0.189
|
0.158 % CD4+ T-cells
Interval 0.13 to 0.298
|
0.142 % CD4+ T-cells
Interval 0.104 to 0.259
|
0.161 % CD4+ T-cells
Interval 0.105 to 0.18
|
SECONDARY outcome
Timeframe: Measured at Months 6.5 and 12.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=31 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=33 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=18 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 12.5)
|
6 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 6.5)
|
28 Participants
|
27 Participants
|
30 Participants
|
18 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 6.5)
|
27 Participants
|
24 Participants
|
26 Participants
|
16 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 6.5)
|
9 Participants
|
13 Participants
|
14 Participants
|
3 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 6.5)
|
9 Participants
|
12 Participants
|
13 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 6.5)
|
19 Participants
|
22 Participants
|
18 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 6.5)
|
28 Participants
|
27 Participants
|
25 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 6.5)
|
27 Participants
|
26 Participants
|
29 Participants
|
17 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 6.5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 6.5)
|
2 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 6.5)
|
3 Participants
|
3 Participants
|
10 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 6.5)
|
3 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 6.5)
|
2 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 12)
|
11 Participants
|
16 Participants
|
17 Participants
|
8 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 12)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 12)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 12)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 12)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 12)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 12)
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 12)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 12)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 12)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 12.5)
|
28 Participants
|
28 Participants
|
29 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 12.5)
|
14 Participants
|
17 Participants
|
14 Participants
|
8 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 12.5)
|
6 Participants
|
9 Participants
|
13 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 12.5)
|
4 Participants
|
7 Participants
|
10 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 12.5)
|
18 Participants
|
21 Participants
|
19 Participants
|
10 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 12.5)
|
25 Participants
|
25 Participants
|
28 Participants
|
13 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 12.5)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 12.5)
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
2 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12.5)
|
1 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 12.5)
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 18)
|
11 Participants
|
16 Participants
|
15 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 18)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 18)
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 18)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 18)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 18)
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 18)
|
6 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 18)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 18)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 18)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 18)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 18)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 6.5 and 12.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=18 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 6.5)
|
3929.5 relative fluorescence units
Interval 2035.8 to 5823.2
|
790 relative fluorescence units
Interval 536.0 to 898.8
|
1142 relative fluorescence units
Interval 760.2 to 1352.5
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 6.5)
|
3242.8 relative fluorescence units
Interval 1691.4 to 5474.6
|
230.2 relative fluorescence units
Interval 223.8 to 407.2
|
512.6 relative fluorescence units
Interval 177.4 to 1562.3
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 6.5)
|
501.8 relative fluorescence units
Interval 339.0 to 6053.9
|
257.5 relative fluorescence units
Interval 250.9 to 440.6
|
1197 relative fluorescence units
Interval 473.6 to 1605.0
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 12)
|
327 relative fluorescence units
Interval 195.5 to 453.1
|
288.8 relative fluorescence units
Interval 203.6 to 805.1
|
164.5 relative fluorescence units
Interval 121.8 to 301.2
|
220.4 relative fluorescence units
Interval 150.2 to 365.7
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 12)
|
297.8 relative fluorescence units
Interval 297.8 to 297.8
|
100.4 relative fluorescence units
Interval 100.2 to 100.6
|
125.8 relative fluorescence units
Interval 125.8 to 125.8
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 12)
|
502.8 relative fluorescence units
Interval 502.8 to 502.8
|
—
|
268.8 relative fluorescence units
Interval 268.8 to 268.8
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
853.5 relative fluorescence units
Interval 564.1 to 1142.9
|
231.6 relative fluorescence units
Interval 181.9 to 281.3
|
487.8 relative fluorescence units
Interval 167.2 to 1114.6
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 18)
|
474 relative fluorescence units
Interval 474.0 to 474.0
|
—
|
—
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 6.5)
|
3002.2 relative fluorescence units
Interval 1394.2 to 5955.3
|
3236 relative fluorescence units
Interval 2115.9 to 8234.4
|
2824 relative fluorescence units
Interval 1284.9 to 4232.1
|
2728.9 relative fluorescence units
Interval 1994.4 to 5368.3
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 6.5)
|
810.5 relative fluorescence units
Interval 364.6 to 2145.9
|
594.5 relative fluorescence units
Interval 318.3 to 1383.3
|
448.1 relative fluorescence units
Interval 315.6 to 1256.3
|
613.2 relative fluorescence units
Interval 299.9 to 965.6
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 6.5)
|
596.8 relative fluorescence units
Interval 267.8 to 1343.5
|
265 relative fluorescence units
Interval 162.2 to 547.5
|
527.2 relative fluorescence units
Interval 338.8 to 1143.7
|
135.2 relative fluorescence units
Interval 128.5 to 350.6
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 6.5)
|
372.2 relative fluorescence units
Interval 154.5 to 885.0
|
218.4 relative fluorescence units
Interval 135.9 to 409.5
|
418.8 relative fluorescence units
Interval 274.8 to 1135.8
|
222.1 relative fluorescence units
Interval 173.3 to 270.9
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 6.5)
|
384.2 relative fluorescence units
Interval 256.2 to 619.1
|
299.2 relative fluorescence units
Interval 222.2 to 645.2
|
260.6 relative fluorescence units
Interval 168.3 to 431.9
|
197.2 relative fluorescence units
Interval 147.8 to 232.1
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 6.5)
|
653.1 relative fluorescence units
Interval 413.8 to 1959.5
|
936.8 relative fluorescence units
Interval 534.8 to 2301.9
|
497.8 relative fluorescence units
Interval 320.0 to 1017.0
|
435.2 relative fluorescence units
Interval 346.5 to 885.0
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 6.5)
|
2134.8 relative fluorescence units
Interval 494.0 to 4958.9
|
1517.2 relative fluorescence units
Interval 618.8 to 2555.9
|
1306.2 relative fluorescence units
Interval 665.0 to 3785.2
|
2277 relative fluorescence units
Interval 1024.2 to 3621.0
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 6.5)
|
4118.6 relative fluorescence units
Interval 2113.9 to 6123.3
|
742 relative fluorescence units
Interval 498.8 to 985.2
|
858.5 relative fluorescence units
Interval 134.6 to 2379.6
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 12)
|
—
|
131.5 relative fluorescence units
Interval 129.2 to 133.8
|
—
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 12)
|
148.2 relative fluorescence units
Interval 148.2 to 148.2
|
—
|
605.9 relative fluorescence units
Interval 363.3 to 848.4
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 12)
|
128.8 relative fluorescence units
Interval 118.9 to 2735.2
|
148.8 relative fluorescence units
Interval 129.4 to 168.0
|
281.5 relative fluorescence units
Interval 236.0 to 1467.5
|
9282.5 relative fluorescence units
Interval 5013.1 to 13551.9
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12)
|
874.8 relative fluorescence units
Interval 874.8 to 874.8
|
—
|
121.8 relative fluorescence units
Interval 121.8 to 121.8
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12)
|
1348.5 relative fluorescence units
Interval 1348.5 to 1348.5
|
225 relative fluorescence units
Interval 225.0 to 225.0
|
—
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 12)
|
798.2 relative fluorescence units
Interval 798.2 to 798.2
|
—
|
—
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 12.5)
|
1049.2 relative fluorescence units
Interval 390.0 to 2565.1
|
1184.2 relative fluorescence units
Interval 711.1 to 3716.6
|
1086.2 relative fluorescence units
Interval 606.8 to 2699.8
|
1739 relative fluorescence units
Interval 593.4 to 5582.2
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 12.5)
|
300.9 relative fluorescence units
Interval 161.9 to 838.8
|
314.5 relative fluorescence units
Interval 149.0 to 681.5
|
314.9 relative fluorescence units
Interval 189.6 to 439.3
|
264.5 relative fluorescence units
Interval 203.9 to 391.0
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 12.5)
|
283.9 relative fluorescence units
Interval 178.3 to 762.0
|
271 relative fluorescence units
Interval 193.5 to 666.2
|
480 relative fluorescence units
Interval 289.2 to 697.0
|
479.1 relative fluorescence units
Interval 308.5 to 5950.9
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 12.5)
|
470 relative fluorescence units
Interval 320.7 to 1060.8
|
197.8 relative fluorescence units
Interval 152.6 to 332.5
|
379.2 relative fluorescence units
Interval 218.2 to 473.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 12.5)
|
284 relative fluorescence units
Interval 197.3 to 345.2
|
329.5 relative fluorescence units
Interval 174.1 to 376.0
|
540 relative fluorescence units
Interval 278.5 to 672.5
|
203 relative fluorescence units
Interval 131.0 to 510.4
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 12.5)
|
264.1 relative fluorescence units
Interval 179.0 to 623.1
|
322.8 relative fluorescence units
Interval 202.2 to 1225.2
|
208.2 relative fluorescence units
Interval 160.5 to 382.6
|
476.8 relative fluorescence units
Interval 118.7 to 581.4
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 12.5)
|
586.8 relative fluorescence units
Interval 385.5 to 2959.5
|
673.8 relative fluorescence units
Interval 415.0 to 2072.2
|
439.4 relative fluorescence units
Interval 199.9 to 1111.1
|
1017.2 relative fluorescence units
Interval 708.0 to 3056.2
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 12.5)
|
—
|
—
|
—
|
3020.8 relative fluorescence units
Interval 3020.8 to 3020.8
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 12.5)
|
157.8 relative fluorescence units
Interval 130.9 to 992.2
|
354 relative fluorescence units
Interval 287.8 to 431.9
|
2402.8 relative fluorescence units
Interval 1323.5 to 3308.5
|
4707.5 relative fluorescence units
Interval 4707.5 to 4707.5
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12.5)
|
2010.8 relative fluorescence units
Interval 2010.8 to 2010.8
|
255.4 relative fluorescence units
Interval 191.4 to 319.3
|
551 relative fluorescence units
Interval 175.0 to 850.4
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 12.5)
|
1262.5 relative fluorescence units
Interval 1262.5 to 1262.5
|
233.5 relative fluorescence units
Interval 205.1 to 261.9
|
1457.8 relative fluorescence units
Interval 642.0 to 2307.9
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 18)
|
204 relative fluorescence units
Interval 146.2 to 522.4
|
266.4 relative fluorescence units
Interval 172.9 to 555.9
|
167.5 relative fluorescence units
Interval 158.5 to 217.5
|
133 relative fluorescence units
Interval 109.4 to 236.1
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 18)
|
187.8 relative fluorescence units
Interval 187.8 to 187.8
|
—
|
245.2 relative fluorescence units
Interval 197.2 to 479.5
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 18)
|
—
|
—
|
368.8 relative fluorescence units
Interval 368.8 to 368.8
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 18)
|
126.6 relative fluorescence units
Interval 100.0 to 155.2
|
136.6 relative fluorescence units
Interval 126.4 to 156.8
|
—
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 18)
|
451.2 relative fluorescence units
Interval 202.6 to 915.9
|
198.9 relative fluorescence units
Interval 125.4 to 362.0
|
725.9 relative fluorescence units
Interval 239.6 to 1298.6
|
6535.8 relative fluorescence units
Interval 3329.8 to 9741.8
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 18)
|
—
|
—
|
—
|
9170.6 relative fluorescence units
Interval 6114.3 to 12226.9
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 18)
|
434.8 relative fluorescence units
Interval 434.8 to 434.8
|
—
|
196.6 relative fluorescence units
Interval 151.1 to 242.2
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 18)
|
534.8 relative fluorescence units
Interval 534.8 to 534.8
|
—
|
170.5 relative fluorescence units
Interval 170.5 to 170.5
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 18)
|
887.5 relative fluorescence units
Interval 887.5 to 887.5
|
—
|
177.5 relative fluorescence units
Interval 177.5 to 177.5
|
—
|
SECONDARY outcome
Timeframe: Measured at Months 6.5 and 12.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=25 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=17 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
00MSA 4076 gp140 (Month 6.5)
|
10 Participants
|
11 Participants
|
17 Participants
|
5 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 6.5)
|
22 Participants
|
19 Participants
|
27 Participants
|
14 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 6.5)
|
12 Participants
|
8 Participants
|
22 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
A1.con.env03 140 CF (Month 6.5)
|
11 Participants
|
8 Participants
|
18 Participants
|
6 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 6.5)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 6.5)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Con 6 gp120/B (Month 6.5)
|
10 Participants
|
9 Participants
|
15 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Con S gp140 CFI (Month 6.5)
|
17 Participants
|
16 Participants
|
24 Participants
|
7 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 6.5)
|
18 Participants
|
19 Participants
|
27 Participants
|
11 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp41 (Month 6.5)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 6.5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 6.5)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 6.5)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 6.5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
00MSA 4076 gp140 (Month 12)
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 12)
|
20 Participants
|
17 Participants
|
24 Participants
|
11 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 12)
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
A1.con.env03 140 CF (Month 12)
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 12)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 12)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Con 6 gp120/B (Month 12)
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Con S gp140 CFI (Month 12)
|
4 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 12)
|
7 Participants
|
10 Participants
|
22 Participants
|
5 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp41 (Month 12)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 12)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 12)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 6.5 and 12.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=22 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=19 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=27 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=14 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
00MSA 4076 gp140 (Month 6.5)
|
1845.2 relative fluorescence units
Interval 488.2 to 8688.9
|
661 relative fluorescence units
Interval 255.5 to 1376.9
|
1434.2 relative fluorescence units
Interval 526.8 to 8249.5
|
2502 relative fluorescence units
Interval 1231.5 to 2833.8
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 6.5)
|
22000 relative fluorescence units
Interval 17472.0 to 22000.0
|
22000 relative fluorescence units
Interval 13255.1 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
20863 relative fluorescence units
Interval 11859.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 6.5)
|
8047.1 relative fluorescence units
Interval 6816.6 to 13252.6
|
8849.6 relative fluorescence units
Interval 6323.8 to 10004.8
|
7595.5 relative fluorescence units
Interval 5318.3 to 13822.1
|
11444 relative fluorescence units
Interval 7878.1 to 15391.1
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
A1.con.env03 140 CF (Month 6.5)
|
2823.8 relative fluorescence units
Interval 535.9 to 8015.5
|
1407.1 relative fluorescence units
Interval 612.2 to 1760.2
|
1909.9 relative fluorescence units
Interval 648.1 to 6867.4
|
2191.9 relative fluorescence units
Interval 1343.3 to 5852.8
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 6.5)
|
6260.8 relative fluorescence units
Interval 6260.8 to 6260.8
|
—
|
1998 relative fluorescence units
Interval 1998.0 to 1998.0
|
4791.2 relative fluorescence units
Interval 4791.2 to 4791.2
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 6.5)
|
9201.2 relative fluorescence units
Interval 9201.2 to 9201.2
|
882.5 relative fluorescence units
Interval 882.5 to 882.5
|
1978.5 relative fluorescence units
Interval 1978.5 to 1978.5
|
4818.8 relative fluorescence units
Interval 4818.8 to 4818.8
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Con 6 gp120/B (Month 6.5)
|
9493.6 relative fluorescence units
Interval 3152.8 to 11729.6
|
3719.8 relative fluorescence units
Interval 3271.2 to 4214.0
|
4863.5 relative fluorescence units
Interval 3355.6 to 7182.0
|
6432.1 relative fluorescence units
Interval 3135.0 to 9692.9
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Con S gp140 CFI (Month 6.5)
|
5888.5 relative fluorescence units
Interval 3208.2 to 17024.2
|
4698.9 relative fluorescence units
Interval 3204.9 to 6151.9
|
6925.8 relative fluorescence units
Interval 3836.3 to 22000.0
|
5943.2 relative fluorescence units
Interval 4851.8 to 13324.0
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 6.5)
|
8312.8 relative fluorescence units
Interval 3759.4 to 19844.6
|
5613.2 relative fluorescence units
Interval 1829.4 to 7662.5
|
12210.8 relative fluorescence units
Interval 6345.9 to 22000.0
|
4144.5 relative fluorescence units
Interval 3052.5 to 13847.4
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp41 (Month 6.5)
|
—
|
3047.2 relative fluorescence units
Interval 3047.2 to 3047.2
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 6.5)
|
813.8 relative fluorescence units
Interval 813.8 to 813.8
|
—
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 6.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
—
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
00MSA 4076 gp140 (Month 12)
|
2229 relative fluorescence units
Interval 1760.0 to 5844.8
|
1486.5 relative fluorescence units
Interval 813.4 to 2417.0
|
1501.5 relative fluorescence units
Interval 421.4 to 3012.2
|
727.5 relative fluorescence units
Interval 727.5 to 727.5
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 12)
|
7533.6 relative fluorescence units
Interval 4651.4 to 16946.0
|
4962.8 relative fluorescence units
Interval 2254.8 to 7956.5
|
9267.8 relative fluorescence units
Interval 5751.8 to 15500.5
|
3780.8 relative fluorescence units
Interval 2303.6 to 9670.9
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 12)
|
5390.6 relative fluorescence units
Interval 4675.2 to 6106.1
|
10692 relative fluorescence units
Interval 8753.4 to 13069.9
|
6160 relative fluorescence units
Interval 5252.9 to 7161.4
|
10678.8 relative fluorescence units
Interval 10678.8 to 10678.8
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
A1.con.env03 140 CF (Month 12)
|
6053.5 relative fluorescence units
Interval 3152.1 to 6928.8
|
2047.2 relative fluorescence units
Interval 1493.4 to 2679.6
|
1051.8 relative fluorescence units
Interval 580.2 to 7617.0
|
1290 relative fluorescence units
Interval 1290.0 to 1290.0
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 12)
|
3551 relative fluorescence units
Interval 3551.0 to 3551.0
|
—
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 12)
|
6647 relative fluorescence units
Interval 6647.0 to 6647.0
|
—
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Con 6 gp120/B (Month 12)
|
3134.5 relative fluorescence units
Interval 2691.1 to 3441.2
|
5267.4 relative fluorescence units
Interval 4380.6 to 6154.2
|
2058 relative fluorescence units
Interval 2014.0 to 3017.9
|
3144 relative fluorescence units
Interval 3144.0 to 3144.0
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Con S gp140 CFI (Month 12)
|
5268 relative fluorescence units
Interval 2966.7 to 10882.8
|
7882.6 relative fluorescence units
Interval 2290.9 to 15009.9
|
5614.8 relative fluorescence units
Interval 3224.8 to 12063.2
|
5104.8 relative fluorescence units
Interval 4650.4 to 5559.1
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 12)
|
3505.5 relative fluorescence units
Interval 1538.2 to 4408.2
|
1366.6 relative fluorescence units
Interval 875.6 to 2180.6
|
2812 relative fluorescence units
Interval 1200.9 to 6530.2
|
4003 relative fluorescence units
Interval 2953.5 to 14074.2
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12)
|
137.5 relative fluorescence units
Interval 137.5 to 137.5
|
993 relative fluorescence units
Interval 993.0 to 993.0
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
—
|
—
|
—
|
|
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 12)
|
—
|
1540 relative fluorescence units
Interval 1540.0 to 1540.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Months 6.5, 12, 12.5, and 18Population: "Overall Number of Participants Analyzed" represents the number of participants in the per-protocol population. "Number Analyzed" shows the number of HIV uninfected participants with available COMPASS data after filtering for assay specific quality control criteria at each timepoint.
COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The functionality score (FS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, irrespective of degree of functionality. FS ranges from zero to one. FS will assign a higher score to participants that exhibit antigen specificity in more cell subsets irrespective of their degree of functionality.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=27 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=31 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=19 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Env-2-ZM96 (Month 12.5)
|
0.024 Functionality Score
Interval 0.013 to 0.061
|
0.065 Functionality Score
Interval 0.022 to 0.098
|
0.023 Functionality Score
Interval 0.018 to 0.038
|
0.033 Functionality Score
Interval 0.013 to 0.071
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
LAI-Gag (Month 18)
|
0.024 Functionality Score
Interval 0.016 to 0.041
|
0.031 Functionality Score
Interval 0.018 to 0.065
|
0.02 Functionality Score
Interval 0.011 to 0.038
|
0.037 Functionality Score
Interval 0.017 to 0.061
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
TV1 gp120 (Month 6.5)
|
0.165 Functionality Score
Interval 0.122 to 0.227
|
0.186 Functionality Score
Interval 0.143 to 0.214
|
0.177 Functionality Score
Interval 0.137 to 0.218
|
0.156 Functionality Score
Interval 0.121 to 0.187
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
TV1 gp120 (Month 12)
|
0.125 Functionality Score
Interval 0.105 to 0.179
|
0.165 Functionality Score
Interval 0.107 to 0.192
|
0.153 Functionality Score
Interval 0.112 to 0.178
|
0.124 Functionality Score
Interval 0.065 to 0.145
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
1086 gp120 (Month 6.5)
|
0.169 Functionality Score
Interval 0.108 to 0.204
|
0.171 Functionality Score
Interval 0.147 to 0.217
|
0.158 Functionality Score
Interval 0.136 to 0.2
|
0.15 Functionality Score
Interval 0.13 to 0.18
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
1086 gp120 (Month 12)
|
0.108 Functionality Score
Interval 0.069 to 0.148
|
0.129 Functionality Score
Interval 0.111 to 0.161
|
0.129 Functionality Score
Interval 0.084 to 0.16
|
0.101 Functionality Score
Interval 0.076 to 0.12
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
1086 gp120 (Month 12.5)
|
0.17 Functionality Score
Interval 0.148 to 0.206
|
0.188 Functionality Score
Interval 0.149 to 0.229
|
0.131 Functionality Score
Interval 0.087 to 0.173
|
0.138 Functionality Score
Interval 0.097 to 0.191
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
1086 gp120 (Month 18)
|
0.143 Functionality Score
Interval 0.118 to 0.185
|
0.156 Functionality Score
Interval 0.126 to 0.179
|
0.111 Functionality Score
Interval 0.079 to 0.165
|
0.114 Functionality Score
Interval 0.091 to 0.139
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Any Env ZM96 (Month 6.5)
|
0.157 Functionality Score
Interval 0.109 to 0.21
|
0.175 Functionality Score
Interval 0.116 to 0.203
|
0.126 Functionality Score
Interval 0.094 to 0.155
|
0.123 Functionality Score
Interval 0.078 to 0.193
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Any Env ZM96 (Month 12)
|
0.126 Functionality Score
Interval 0.085 to 0.166
|
0.129 Functionality Score
Interval 0.115 to 0.159
|
0.106 Functionality Score
Interval 0.068 to 0.13
|
0.111 Functionality Score
Interval 0.093 to 0.15
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Any Env ZM96 (Month 12.5)
|
0.187 Functionality Score
Interval 0.12 to 0.225
|
0.197 Functionality Score
Interval 0.142 to 0.224
|
0.117 Functionality Score
Interval 0.087 to 0.144
|
0.158 Functionality Score
Interval 0.12 to 0.183
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Any Env ZM96 (Month 18)
|
0.159 Functionality Score
Interval 0.089 to 0.179
|
0.163 Functionality Score
Interval 0.112 to 0.181
|
0.11 Functionality Score
Interval 0.083 to 0.128
|
0.131 Functionality Score
Interval 0.054 to 0.157
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Env-1-ZM96 (Month 6.5)
|
0.157 Functionality Score
Interval 0.109 to 0.21
|
0.177 Functionality Score
Interval 0.119 to 0.203
|
0.126 Functionality Score
Interval 0.094 to 0.155
|
0.123 Functionality Score
Interval 0.078 to 0.193
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Env-1-ZM96 (Month 12)
|
0.126 Functionality Score
Interval 0.085 to 0.166
|
0.129 Functionality Score
Interval 0.115 to 0.159
|
0.106 Functionality Score
Interval 0.068 to 0.124
|
0.111 Functionality Score
Interval 0.093 to 0.15
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Env-1-ZM96 (Month 12.5)
|
0.187 Functionality Score
Interval 0.12 to 0.225
|
0.197 Functionality Score
Interval 0.142 to 0.224
|
0.117 Functionality Score
Interval 0.087 to 0.144
|
0.158 Functionality Score
Interval 0.12 to 0.183
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Env-1-ZM96 (Month 18)
|
0.159 Functionality Score
Interval 0.089 to 0.179
|
0.163 Functionality Score
Interval 0.112 to 0.181
|
0.11 Functionality Score
Interval 0.082 to 0.128
|
0.131 Functionality Score
Interval 0.054 to 0.157
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Env-2-ZM96 (Month 6.5)
|
0.032 Functionality Score
Interval 0.015 to 0.072
|
0.027 Functionality Score
Interval 0.017 to 0.076
|
0.04 Functionality Score
Interval 0.028 to 0.068
|
0.046 Functionality Score
Interval 0.023 to 0.062
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Env-2-ZM96 (Month 12)
|
0.015 Functionality Score
Interval 0.003 to 0.024
|
0.044 Functionality Score
Interval 0.015 to 0.074
|
0.032 Functionality Score
Interval 0.011 to 0.072
|
0.033 Functionality Score
Interval 0.018 to 0.047
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
Env-2-ZM96 (Month 18)
|
0.016 Functionality Score
Interval 0.007 to 0.026
|
0.039 Functionality Score
Interval 0.019 to 0.082
|
0.021 Functionality Score
Interval 0.011 to 0.062
|
0.028 Functionality Score
Interval 0.011 to 0.039
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
LAI-Gag (Month 6.5)
|
0.04 Functionality Score
Interval 0.021 to 0.069
|
0.057 Functionality Score
Interval 0.027 to 0.071
|
0.03 Functionality Score
Interval 0.012 to 0.039
|
0.036 Functionality Score
Interval 0.029 to 0.069
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
LAI-Gag (Month 12)
|
0.04 Functionality Score
Interval 0.014 to 0.053
|
0.04 Functionality Score
Interval 0.015 to 0.066
|
0.025 Functionality Score
Interval 0.009 to 0.042
|
0.026 Functionality Score
Interval 0.016 to 0.05
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
LAI-Gag (Month 12.5)
|
0.03 Functionality Score
Interval 0.016 to 0.07
|
0.041 Functionality Score
Interval 0.02 to 0.069
|
0.037 Functionality Score
Interval 0.023 to 0.055
|
0.038 Functionality Score
Interval 0.012 to 0.068
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
TV1 gp120 (Month 12.5)
|
0.217 Functionality Score
Interval 0.173 to 0.232
|
0.231 Functionality Score
Interval 0.161 to 0.252
|
0.172 Functionality Score
Interval 0.125 to 0.207
|
0.15 Functionality Score
Interval 0.113 to 0.205
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
TV1 gp120 (Month 18)
|
0.161 Functionality Score
Interval 0.136 to 0.21
|
0.172 Functionality Score
Interval 0.16 to 0.199
|
0.143 Functionality Score
Interval 0.119 to 0.177
|
0.099 Functionality Score
Interval 0.055 to 0.17
|
SECONDARY outcome
Timeframe: Measured at Months 6.5, 12, 12.5, and 18Population: "Overall Number of Participants Analyzed" represents the number of participants in the per-protocol population. "Number Analyzed" shows the number of HIV uninfected participants with available COMPASS data after filtering for assay specific quality control criteria at each timepoint.
COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The polyfunctionality score (PFS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, weighted by the degree of functionality of the corresponding subset. PFS ranges from zero to one. PFS will assign a higher score to participants with antigen-specific cell subsets of higher degree.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=27 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=31 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=19 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
TV1 gp120 (Month 18)
|
0.109 Polyfunctionality Score
Interval 0.073 to 0.14
|
0.118 Polyfunctionality Score
Interval 0.112 to 0.135
|
0.084 Polyfunctionality Score
Interval 0.061 to 0.11
|
0.069 Polyfunctionality Score
Interval 0.035 to 0.106
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
LAI-Gag (Month 6.5)
|
0.051 Polyfunctionality Score
Interval 0.017 to 0.064
|
0.055 Polyfunctionality Score
Interval 0.024 to 0.072
|
0.025 Polyfunctionality Score
Interval 0.008 to 0.051
|
0.038 Polyfunctionality Score
Interval 0.031 to 0.072
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
LAI-Gag (Month 18)
|
0.02 Polyfunctionality Score
Interval 0.015 to 0.039
|
0.027 Polyfunctionality Score
Interval 0.019 to 0.062
|
0.017 Polyfunctionality Score
Interval 0.006 to 0.033
|
0.035 Polyfunctionality Score
Interval 0.017 to 0.059
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
TV1 gp120 (Month 6.5)
|
0.111 Polyfunctionality Score
Interval 0.076 to 0.146
|
0.13 Polyfunctionality Score
Interval 0.095 to 0.142
|
0.108 Polyfunctionality Score
Interval 0.075 to 0.136
|
0.091 Polyfunctionality Score
Interval 0.06 to 0.122
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
LAI-Gag (Month 12)
|
0.036 Polyfunctionality Score
Interval 0.008 to 0.055
|
0.027 Polyfunctionality Score
Interval 0.006 to 0.05
|
0.019 Polyfunctionality Score
Interval 0.007 to 0.036
|
0.027 Polyfunctionality Score
Interval 0.012 to 0.059
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
LAI-Gag (Month 12.5)
|
0.031 Polyfunctionality Score
Interval 0.014 to 0.061
|
0.035 Polyfunctionality Score
Interval 0.019 to 0.058
|
0.038 Polyfunctionality Score
Interval 0.021 to 0.054
|
0.035 Polyfunctionality Score
Interval 0.009 to 0.067
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
1086 gp120 (Month 6.5)
|
0.11 Polyfunctionality Score
Interval 0.051 to 0.135
|
0.12 Polyfunctionality Score
Interval 0.095 to 0.141
|
0.098 Polyfunctionality Score
Interval 0.065 to 0.122
|
0.106 Polyfunctionality Score
Interval 0.09 to 0.116
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
1086 gp120 (Month 12)
|
0.067 Polyfunctionality Score
Interval 0.05 to 0.105
|
0.087 Polyfunctionality Score
Interval 0.064 to 0.113
|
0.062 Polyfunctionality Score
Interval 0.049 to 0.098
|
0.07 Polyfunctionality Score
Interval 0.038 to 0.081
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
1086 gp120 (Month 12.5)
|
0.108 Polyfunctionality Score
Interval 0.076 to 0.135
|
0.129 Polyfunctionality Score
Interval 0.082 to 0.148
|
0.067 Polyfunctionality Score
Interval 0.048 to 0.098
|
0.091 Polyfunctionality Score
Interval 0.053 to 0.109
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
1086 gp120 (Month 18)
|
0.1 Polyfunctionality Score
Interval 0.072 to 0.121
|
0.108 Polyfunctionality Score
Interval 0.08 to 0.126
|
0.062 Polyfunctionality Score
Interval 0.044 to 0.099
|
0.064 Polyfunctionality Score
Interval 0.056 to 0.09
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Any Env ZM96 (Month 6.5)
|
0.111 Polyfunctionality Score
Interval 0.084 to 0.134
|
0.124 Polyfunctionality Score
Interval 0.091 to 0.136
|
0.083 Polyfunctionality Score
Interval 0.051 to 0.105
|
0.092 Polyfunctionality Score
Interval 0.058 to 0.124
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Any Env ZM96 (Month 12)
|
0.082 Polyfunctionality Score
Interval 0.063 to 0.119
|
0.099 Polyfunctionality Score
Interval 0.062 to 0.107
|
0.06 Polyfunctionality Score
Interval 0.042 to 0.086
|
0.09 Polyfunctionality Score
Interval 0.049 to 0.101
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Any Env ZM96 (Month 12.5)
|
0.127 Polyfunctionality Score
Interval 0.087 to 0.146
|
0.132 Polyfunctionality Score
Interval 0.088 to 0.144
|
0.069 Polyfunctionality Score
Interval 0.046 to 0.09
|
0.111 Polyfunctionality Score
Interval 0.088 to 0.12
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Any Env ZM96 (Month 18)
|
0.114 Polyfunctionality Score
Interval 0.064 to 0.127
|
0.115 Polyfunctionality Score
Interval 0.083 to 0.126
|
0.066 Polyfunctionality Score
Interval 0.042 to 0.095
|
0.085 Polyfunctionality Score
Interval 0.046 to 0.111
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Env-1-ZM96 (Month 6.5)
|
0.111 Polyfunctionality Score
Interval 0.084 to 0.134
|
0.124 Polyfunctionality Score
Interval 0.094 to 0.136
|
0.083 Polyfunctionality Score
Interval 0.051 to 0.105
|
0.092 Polyfunctionality Score
Interval 0.058 to 0.124
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Env-1-ZM96 (Month 12)
|
0.082 Polyfunctionality Score
Interval 0.063 to 0.119
|
0.099 Polyfunctionality Score
Interval 0.062 to 0.107
|
0.057 Polyfunctionality Score
Interval 0.042 to 0.073
|
0.09 Polyfunctionality Score
Interval 0.049 to 0.101
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Env-1-ZM96 (Month 12.5)
|
0.127 Polyfunctionality Score
Interval 0.087 to 0.146
|
0.132 Polyfunctionality Score
Interval 0.088 to 0.144
|
0.069 Polyfunctionality Score
Interval 0.044 to 0.09
|
0.111 Polyfunctionality Score
Interval 0.088 to 0.12
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Env-1-ZM96 (Month 18)
|
0.114 Polyfunctionality Score
Interval 0.064 to 0.127
|
0.115 Polyfunctionality Score
Interval 0.083 to 0.126
|
0.066 Polyfunctionality Score
Interval 0.039 to 0.095
|
0.085 Polyfunctionality Score
Interval 0.046 to 0.111
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Env-2-ZM96 (Month 6.5)
|
0.019 Polyfunctionality Score
Interval 0.011 to 0.05
|
0.026 Polyfunctionality Score
Interval 0.013 to 0.066
|
0.029 Polyfunctionality Score
Interval 0.014 to 0.037
|
0.023 Polyfunctionality Score
Interval 0.018 to 0.036
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Env-2-ZM96 (Month 12)
|
0.01 Polyfunctionality Score
Interval 0.001 to 0.015
|
0.026 Polyfunctionality Score
Interval 0.012 to 0.044
|
0.028 Polyfunctionality Score
Interval 0.009 to 0.042
|
0.02 Polyfunctionality Score
Interval 0.014 to 0.029
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Env-2-ZM96 (Month 12.5)
|
0.015 Polyfunctionality Score
Interval 0.006 to 0.045
|
0.039 Polyfunctionality Score
Interval 0.014 to 0.07
|
0.017 Polyfunctionality Score
Interval 0.009 to 0.034
|
0.02 Polyfunctionality Score
Interval 0.006 to 0.045
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
Env-2-ZM96 (Month 18)
|
0.013 Polyfunctionality Score
Interval 0.005 to 0.019
|
0.025 Polyfunctionality Score
Interval 0.013 to 0.051
|
0.012 Polyfunctionality Score
Interval 0.008 to 0.04
|
0.022 Polyfunctionality Score
Interval 0.011 to 0.029
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
TV1 gp120 (Month 12)
|
0.079 Polyfunctionality Score
Interval 0.056 to 0.109
|
0.111 Polyfunctionality Score
Interval 0.071 to 0.12
|
0.084 Polyfunctionality Score
Interval 0.056 to 0.115
|
0.078 Polyfunctionality Score
Interval 0.031 to 0.095
|
|
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
TV1 gp120 (Month 12.5)
|
0.137 Polyfunctionality Score
Interval 0.094 to 0.147
|
0.146 Polyfunctionality Score
Interval 0.113 to 0.157
|
0.095 Polyfunctionality Score
Interval 0.062 to 0.129
|
0.1 Polyfunctionality Score
Interval 0.071 to 0.133
|
SECONDARY outcome
Timeframe: Measured at Months 12.5 and 18.Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=16 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 12.5)
|
30 Participants
|
27 Participants
|
31 Participants
|
16 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 12.5)
|
26 Participants
|
28 Participants
|
30 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 12.5)
|
28 Participants
|
28 Participants
|
29 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 18)
|
27 Participants
|
27 Participants
|
32 Participants
|
16 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 18)
|
17 Participants
|
22 Participants
|
28 Participants
|
7 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 18)
|
26 Participants
|
28 Participants
|
30 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 12.5 and 18.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=16 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
1086C_D7gp120.avi/293F (Month 18)
|
22000 relative fluorescence units
Interval 13447.4 to 22000.0
|
22000 relative fluorescence units
Interval 17031.4 to 22000.0
|
22000 relative fluorescence units
Interval 16465.8 to 22000.0
|
16187 relative fluorescence units
Interval 8260.8 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
96ZM651.D11gp120.avi (Month 18)
|
6135.8 relative fluorescence units
Interval 4058.2 to 10887.0
|
5439 relative fluorescence units
Interval 2617.8 to 8736.1
|
5372.6 relative fluorescence units
Interval 3140.4 to 12123.9
|
2794 relative fluorescence units
Interval 2226.0 to 4364.1
|
|
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
TV1c8_D11gp120.avi/293F (Month 18)
|
8367.6 relative fluorescence units
Interval 2745.8 to 21097.6
|
8893.4 relative fluorescence units
Interval 3450.6 to 20507.7
|
20549 relative fluorescence units
Interval 8176.7 to 22000.0
|
6794.5 relative fluorescence units
Interval 2788.2 to 9961.5
|
SECONDARY outcome
Timeframe: Measured at Months 12.5 and 18.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=16 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 18)
|
11 Participants
|
12 Participants
|
18 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 12.5)
|
26 Participants
|
28 Participants
|
29 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 12.5)
|
27 Participants
|
28 Participants
|
29 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 12.5)
|
21 Participants
|
27 Participants
|
27 Participants
|
14 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 12.5)
|
19 Participants
|
21 Participants
|
22 Participants
|
9 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 12.5)
|
26 Participants
|
28 Participants
|
29 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 12.5)
|
28 Participants
|
28 Participants
|
30 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 12.5)
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 12.5)
|
10 Participants
|
18 Participants
|
18 Participants
|
7 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
16 Participants
|
25 Participants
|
24 Participants
|
9 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12.5)
|
12 Participants
|
22 Participants
|
23 Participants
|
8 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 12.5)
|
11 Participants
|
20 Participants
|
22 Participants
|
6 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 18)
|
23 Participants
|
26 Participants
|
29 Participants
|
11 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 18)
|
5 Participants
|
9 Participants
|
12 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 18)
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 18)
|
13 Participants
|
17 Participants
|
25 Participants
|
6 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 18)
|
25 Participants
|
28 Participants
|
31 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 18)
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 18)
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 18)
|
4 Participants
|
10 Participants
|
11 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 18)
|
1 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 18)
|
1 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 12.5 and 18.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=30 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=16 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 18)
|
137 relative fluorescence units
Interval 110.2 to 484.0
|
462 relative fluorescence units
Interval 371.2 to 512.5
|
362.2 relative fluorescence units
Interval 194.8 to 1003.6
|
445.9 relative fluorescence units
Interval 429.3 to 462.4
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 18)
|
314.2 relative fluorescence units
Interval 314.2 to 314.2
|
1717.6 relative fluorescence units
Interval 1210.9 to 2224.3
|
623.8 relative fluorescence units
Interval 383.3 to 886.9
|
593.2 relative fluorescence units
Interval 593.2 to 593.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12.5)
|
1213.2 relative fluorescence units
Interval 734.6 to 3588.6
|
2332.9 relative fluorescence units
Interval 732.9 to 5249.1
|
8987.2 relative fluorescence units
Interval 2613.6 to 22000.0
|
1324.4 relative fluorescence units
Interval 941.3 to 3481.6
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 12.5)
|
22000 relative fluorescence units
Interval 18877.6 to 22000.0
|
22000 relative fluorescence units
Interval 13449.4 to 22000.0
|
22000 relative fluorescence units
Interval 17787.8 to 22000.0
|
22000 relative fluorescence units
Interval 11267.2 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 12.5)
|
22000 relative fluorescence units
Interval 20752.0 to 22000.0
|
22000 relative fluorescence units
Interval 17453.4 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 16264.4 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
AE.A244 V1V2 Tags/293F (Month 12.5)
|
4553.5 relative fluorescence units
Interval 2286.2 to 9393.8
|
3313.8 relative fluorescence units
Interval 1245.9 to 10641.6
|
5728.8 relative fluorescence units
Interval 2011.8 to 10929.1
|
1034.2 relative fluorescence units
Interval 482.6 to 5401.9
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 12.5)
|
2021.2 relative fluorescence units
Interval 1142.2 to 3862.8
|
3476 relative fluorescence units
Interval 906.0 to 6288.5
|
3484.6 relative fluorescence units
Interval 994.0 to 8674.6
|
1380.2 relative fluorescence units
Interval 601.0 to 3883.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 20433.4 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 15222.2 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 12.5)
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 12.5)
|
—
|
—
|
4644.8 relative fluorescence units
Interval 3651.8 to 13322.4
|
8348.5 relative fluorescence units
Interval 5951.1 to 10745.9
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 12.5)
|
1427.2 relative fluorescence units
Interval 891.8 to 9947.6
|
3770.8 relative fluorescence units
Interval 1125.0 to 10077.4
|
8793.6 relative fluorescence units
Interval 1318.6 to 21615.9
|
1639.8 relative fluorescence units
Interval 1290.2 to 6055.9
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
1407.4 relative fluorescence units
Interval 993.3 to 3027.4
|
2057.8 relative fluorescence units
Interval 714.5 to 6260.2
|
12436.5 relative fluorescence units
Interval 1806.4 to 22000.0
|
2031.8 relative fluorescence units
Interval 1158.8 to 4055.5
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA_V1_V2 (Month 12.5)
|
763.5 relative fluorescence units
Interval 670.1 to 3615.2
|
2246.5 relative fluorescence units
Interval 999.1 to 5417.9
|
8372.5 relative fluorescence units
Interval 1587.8 to 21441.9
|
2869.5 relative fluorescence units
Interval 1171.8 to 4368.3
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
00MSA 4076 gp140 (Month 18)
|
1954 relative fluorescence units
Interval 1242.2 to 3022.0
|
2546.9 relative fluorescence units
Interval 1072.2 to 7260.1
|
1571 relative fluorescence units
Interval 1131.2 to 3575.8
|
1351.9 relative fluorescence units
Interval 1189.6 to 1367.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
A1.con.env03 140 CF (Month 18)
|
1106 relative fluorescence units
Interval 444.2 to 2628.0
|
1552.5 relative fluorescence units
Interval 607.0 to 3231.8
|
1853.2 relative fluorescence units
Interval 929.5 to 4194.5
|
961.5 relative fluorescence units
Interval 695.8 to 1429.6
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
C.1086C_V1_V2 Tags (Month 18)
|
1204.5 relative fluorescence units
Interval 1204.5 to 1204.5
|
1523.2 relative fluorescence units
Interval 1067.4 to 5288.9
|
821.8 relative fluorescence units
Interval 714.1 to 2419.4
|
909 relative fluorescence units
Interval 909.0 to 909.0
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con 6 gp120/B (Month 18)
|
2373.2 relative fluorescence units
Interval 1574.0 to 4438.2
|
2805 relative fluorescence units
Interval 1459.5 to 4348.8
|
2405.5 relative fluorescence units
Interval 1517.5 to 4459.5
|
1185.2 relative fluorescence units
Interval 993.6 to 1463.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Con S gp140 CFI (Month 18)
|
8793.8 relative fluorescence units
Interval 3178.8 to 16947.8
|
9031.1 relative fluorescence units
Interval 3772.2 to 22000.0
|
13261.8 relative fluorescence units
Interval 7458.2 to 22000.0
|
5032.5 relative fluorescence units
Interval 3082.0 to 9318.4
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp41 (Month 18)
|
—
|
2549.2 relative fluorescence units
Interval 2549.2 to 2549.2
|
7284.8 relative fluorescence units
Interval 5785.5 to 14642.4
|
19096.5 relative fluorescence units
Interval 19096.5 to 19096.5
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-96ZM651.02 V1v2 (Month 18)
|
370.8 relative fluorescence units
Interval 370.8 to 370.8
|
584 relative fluorescence units
Interval 541.4 to 872.1
|
987.8 relative fluorescence units
Interval 590.4 to 1672.9
|
2221.8 relative fluorescence units
Interval 2221.8 to 2221.8
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 18)
|
163.1 relative fluorescence units
Interval 125.2 to 272.5
|
180.2 relative fluorescence units
Interval 130.4 to 208.4
|
1319.2 relative fluorescence units
Interval 605.5 to 1729.8
|
1114.2 relative fluorescence units
Interval 1114.2 to 1114.2
|
|
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 18)
|
244.5 relative fluorescence units
Interval 244.5 to 244.5
|
1593.8 relative fluorescence units
Interval 914.8 to 1638.4
|
1332 relative fluorescence units
Interval 425.0 to 1556.0
|
1227.5 relative fluorescence units
Interval 1227.5 to 1227.5
|
SECONDARY outcome
Timeframe: Measured at Months 12.5 and 18.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=31 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=32 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=17 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 18)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 18)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 18)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 12.5)
|
28 Participants
|
28 Participants
|
29 Participants
|
15 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 12.5)
|
14 Participants
|
17 Participants
|
14 Participants
|
8 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 12.5)
|
6 Participants
|
9 Participants
|
13 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 12.5)
|
4 Participants
|
7 Participants
|
10 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 12.5)
|
6 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 12.5)
|
18 Participants
|
21 Participants
|
19 Participants
|
10 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 12.5)
|
25 Participants
|
25 Participants
|
28 Participants
|
13 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 12.5)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 12.5)
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
2 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12.5)
|
1 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 12.5)
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 18)
|
11 Participants
|
16 Participants
|
15 Participants
|
4 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 18)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 18)
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 18)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 18)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 18)
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 18)
|
6 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 18)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 18)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 12.5 and 18.Population: "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Outcome measures
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=28 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=29 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=15 Participants
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
C.1086C_V1_V2 Tags (Month 12.5)
|
470 relative fluorescence units
Interval 320.7 to 1060.8
|
197.8 relative fluorescence units
Interval 152.6 to 332.5
|
379.2 relative fluorescence units
Interval 218.2 to 473.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
853.5 relative fluorescence units
Interval 564.1 to 1142.9
|
231.6 relative fluorescence units
Interval 181.9 to 281.3
|
487.8 relative fluorescence units
Interval 167.2 to 1114.6
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 12.5)
|
1049.2 relative fluorescence units
Interval 390.0 to 2565.1
|
1184.2 relative fluorescence units
Interval 711.1 to 3716.6
|
1086.2 relative fluorescence units
Interval 606.8 to 2699.8
|
1739 relative fluorescence units
Interval 593.4 to 5582.2
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
96ZM651.D11gp120.avi (Month 12.5)
|
300.9 relative fluorescence units
Interval 161.9 to 838.8
|
314.5 relative fluorescence units
Interval 149.0 to 681.5
|
314.9 relative fluorescence units
Interval 189.6 to 439.3
|
264.5 relative fluorescence units
Interval 203.9 to 391.0
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 12.5)
|
283.9 relative fluorescence units
Interval 178.3 to 762.0
|
271 relative fluorescence units
Interval 193.5 to 666.2
|
480 relative fluorescence units
Interval 289.2 to 697.0
|
479.1 relative fluorescence units
Interval 308.5 to 5950.9
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 12.5)
|
284 relative fluorescence units
Interval 197.3 to 345.2
|
329.5 relative fluorescence units
Interval 174.1 to 376.0
|
540 relative fluorescence units
Interval 278.5 to 672.5
|
203 relative fluorescence units
Interval 131.0 to 510.4
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 12.5)
|
264.1 relative fluorescence units
Interval 179.0 to 623.1
|
322.8 relative fluorescence units
Interval 202.2 to 1225.2
|
208.2 relative fluorescence units
Interval 160.5 to 382.6
|
476.8 relative fluorescence units
Interval 118.7 to 581.4
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 12.5)
|
586.8 relative fluorescence units
Interval 385.5 to 2959.5
|
673.8 relative fluorescence units
Interval 415.0 to 2072.2
|
439.4 relative fluorescence units
Interval 199.9 to 1111.1
|
1017.2 relative fluorescence units
Interval 708.0 to 3056.2
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 12.5)
|
—
|
—
|
—
|
3020.8 relative fluorescence units
Interval 3020.8 to 3020.8
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 12.5)
|
157.8 relative fluorescence units
Interval 130.9 to 992.2
|
354 relative fluorescence units
Interval 287.8 to 431.9
|
2402.8 relative fluorescence units
Interval 1323.5 to 3308.5
|
4707.5 relative fluorescence units
Interval 4707.5 to 4707.5
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 12.5)
|
2010.8 relative fluorescence units
Interval 2010.8 to 2010.8
|
255.4 relative fluorescence units
Interval 191.4 to 319.3
|
551 relative fluorescence units
Interval 175.0 to 850.4
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 12.5)
|
1262.5 relative fluorescence units
Interval 1262.5 to 1262.5
|
233.5 relative fluorescence units
Interval 205.1 to 261.9
|
1457.8 relative fluorescence units
Interval 642.0 to 2307.9
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
1086C_D7gp120.avi/293F (Month 18)
|
204 relative fluorescence units
Interval 146.2 to 522.4
|
266.4 relative fluorescence units
Interval 172.9 to 555.9
|
167.5 relative fluorescence units
Interval 158.5 to 217.5
|
133 relative fluorescence units
Interval 109.4 to 236.1
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
AE.A244 V1V2 Tags/293F (Month 18)
|
187.8 relative fluorescence units
Interval 187.8 to 187.8
|
—
|
245.2 relative fluorescence units
Interval 197.2 to 479.5
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con 6 gp120/B (Month 18)
|
—
|
—
|
368.8 relative fluorescence units
Interval 368.8 to 368.8
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Con S gp140 CFI (Month 18)
|
126.6 relative fluorescence units
Interval 100.0 to 155.2
|
136.6 relative fluorescence units
Interval 126.4 to 156.8
|
—
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
TV1c8_D11gp120.avi/293F (Month 18)
|
451.2 relative fluorescence units
Interval 202.6 to 915.9
|
198.9 relative fluorescence units
Interval 125.4 to 362.0
|
725.9 relative fluorescence units
Interval 239.6 to 1298.6
|
6535.8 relative fluorescence units
Interval 3329.8 to 9741.8
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp41 (Month 18)
|
—
|
—
|
—
|
9170.6 relative fluorescence units
Interval 6114.3 to 12226.9
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-96ZM651.02 V1v2 (Month 18)
|
434.8 relative fluorescence units
Interval 434.8 to 434.8
|
—
|
196.6 relative fluorescence units
Interval 151.1 to 242.2
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70-TV1.GSKvacV1V2/293F (Month 18)
|
534.8 relative fluorescence units
Interval 534.8 to 534.8
|
—
|
170.5 relative fluorescence units
Interval 170.5 to 170.5
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA2 V1/V2/169K (Month 18)
|
887.5 relative fluorescence units
Interval 887.5 to 887.5
|
—
|
177.5 relative fluorescence units
Interval 177.5 to 177.5
|
—
|
|
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
gp70_B.CaseA_V1_V2 (Month 18)
|
474 relative fluorescence units
Interval 474.0 to 474.0
|
—
|
—
|
—
|
Adverse Events
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 participants at risk
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 participants at risk
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 participants at risk
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 participants at risk
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
Other adverse events
| Measure |
Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)
n=36 participants at risk
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)
n=36 participants at risk
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)
n=36 participants at risk
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
|
Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)
n=24 participants at risk
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Any Event in SOC
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Ear and labyrinth disorders
Any Event in SOC
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Eye disorders
Any Event in SOC
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Eye disorders
Conjunctivitis allergic
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Eye disorders
Eye pain
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Any Event in SOC
|
11.1%
4/36 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
11.1%
4/36 • Number of events 6 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Dental caries
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Any Event in SOC
|
11.1%
4/36 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Asthenia
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Influenza like illness
|
5.6%
2/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Peripheral swelling
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Vessel puncture site phlebitis
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Any Event in SOC
|
41.7%
15/36 • Number of events 29 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
38.9%
14/36 • Number of events 26 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
27.8%
10/36 • Number of events 16 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
45.8%
11/24 • Number of events 16 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
3/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
2/24 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Body tinea
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Furuncle
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
3/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Gastroenteritis viral
|
5.6%
2/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Genitourinary chlamydia infection
|
11.1%
4/36 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
13.9%
5/36 • Number of events 8 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
5.6%
2/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Malaria
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Orchitis
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Respiratory tract infection
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Rhinitis
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Sinusitis
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
3/36 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
11.1%
4/36 • Number of events 6 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
2/24 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Vulvovaginitis gonococcal
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
11.1%
4/36 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
12.5%
3/24 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Any Event in SOC
|
55.6%
20/36 • Number of events 35 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
38.9%
14/36 • Number of events 26 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
27.8%
10/36 • Number of events 17 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
25.0%
6/24 • Number of events 10 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
3/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
11.1%
4/36 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
2/24 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Blood bicarbonate decreased
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Blood creatinine increased
|
27.8%
10/36 • Number of events 17 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
16.7%
6/36 • Number of events 8 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
11.1%
4/36 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
2/24 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Blood pressure increased
|
8.3%
3/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Cardiac murmur
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Haemoglobin decreased
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
13.9%
5/36 • Number of events 6 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Neutrophil count decreased
|
11.1%
4/36 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Platelet count decreased
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
White blood cell count decreased
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
13.9%
5/36 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
2/24 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Any Event in SOC
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
16.7%
6/36 • Number of events 7 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
11.1%
4/36 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Syncope
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Any Event in SOC
|
5.6%
2/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
12.5%
3/24 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Proteinuria
|
5.6%
2/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Any Event in SOC
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
3/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
8.3%
3/36 • Number of events 3 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
11.1%
4/36 • Number of events 5 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
11.1%
4/36 • Number of events 4 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.6%
2/36 • Number of events 2 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.8%
1/36 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Vascular disorders
Any Event in SOC
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/36 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place