Trial Outcomes & Findings for Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461) (NCT NCT03368053)
NCT ID: NCT03368053
Last Updated: 2020-10-20
Results Overview
To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. The C.1086C\_V1\_V2 Tags strain was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
Results posted on
2020-10-20
Participant Flow
This study was conducted at one Centre in Belgium.
A total of 36 subjects were enrolled in the study. Those subjects received at least three doses of the GSKSB732461 vaccine candidate in GSK-sponsored 732461/002 (PRO HIV-002) study.
Participant milestones
| Measure |
GSKSB732461 Group
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Baseline characteristics by cohort
| Measure |
GSKSB732461 Group
n=36 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Age, Continuous
|
43.5 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE - CAUCASIAN / EUROPEAN HERITAGE
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. The C.1086C\_V1\_V2 Tags strain was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Outcome measures
| Measure |
GSKSB732461 Group
n=27 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-BJOX002000.03.2 strain, at Day 672
|
14 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-001428.2.42 strain, at Day 182
|
25 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-001428.2.42 strain, at Day 672
|
15 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-001428.2.42 strain, at Year 14
|
8 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-191084_B7 strain, at Day 182
|
20 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-191084_B7 strain, at Day 672
|
12 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-191084_B7 strain, at Year 14
|
9 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-62357.14 strain, at Day 182
|
12 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-62357.14 strain, at Day 672
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-62357.14 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-700010058 strain, at Day 182
|
26 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-700010058 strain, at Day 672
|
19 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-700010058 strain, at Year 14
|
13 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-7060101641 strain, at Day 182
|
18 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-7060101641 strain, at Day 672
|
9 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-7060101641 strain, at Year 14
|
4 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-96ZM651.02 strain, at Day 182
|
21 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-96ZM651.02 strain, at Day 672
|
4 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-96ZM651.02 strain, at Year 14
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-BF1266_431a strain, at Day 182
|
24 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-BF1266_431a strain, at Day 672
|
16 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-BF1266_431a strain, at Year 14
|
11 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-BJOX002000.03.2 strain, at Day 182
|
24 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-BJOX002000.03.2 strain, at Year 14
|
6 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-C2101.c01 strain, at Day 182
|
20 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-C2101.c01 strain, at Day 672
|
12 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-C2101.c01 strain, at Year 14
|
8 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-CAP210.2.00.E8 strain, at Day 182
|
26 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-CAP210.2.00.E8 strain, at Day 672
|
15 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-CAP210.2.00.E8 strain, at Year 14
|
7 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-CM244.ec1 strain, Day 182
|
22 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-CM244.ec1 strain, at Day 672
|
13 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-CM244.ec1 strain, at Year 14
|
7 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-Ce1086_B2 strain, at Day 182
|
23 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-Ce1086_B2 strain, at Day 672
|
14 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-Ce1086_B2 strain, at Year 14
|
6 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-RHPA4259.7 strain, at Day 182
|
22 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-RHPA4259.7 strain, at Day 672
|
9 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-RHPA4259.7 strain, at Year 14
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-TT31P.2F10.2792 strain, at Day 182
|
26 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-TT31P.2F10.2792 strain, at Day 672
|
18 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-TT31P.2F10.2792 strain, at Year 14
|
10 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-TV1.21 strain, at Day 182
|
26 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-TV1.21 strain, at Day 672
|
18 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70-TV1.21 strain, at Year 14
|
9 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70_B.CaseA strain, at Day 182
|
26 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70_B.CaseA strain, at Day 672
|
21 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
gp70_B.CaseA strain, at Year 14
|
12 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
C.1086C_V1_V2 Tags strain, at Day 182
|
19 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
C.1086C_V1_V2 Tags strain, at Day 672
|
5 Participants
|
|
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
C.1086C_V1_V2 Tags strain, at Year 14
|
3 Participants
|
PRIMARY outcome
Timeframe: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". The C.1086C\_V1\_V2 Tags strain was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Outcome measures
| Measure |
GSKSB732461 Group
n=32 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-CM244.ec1 strain, at Day 182
|
2770.8 MFI
Interval 1057.6 to 7259.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-CM244.ec1 strain, at Day 672
|
98.6 MFI
Interval 22.7 to 429.2
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-CM244.ec strain, at Year 14
|
33.0 MFI
Interval 8.7 to 124.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-Ce1086_B2 strain, at Day 0
|
1.3 MFI
Interval 0.9 to 2.0
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-001428.2.42 strain, at Day 0
|
1.3 MFI
Interval 0.9 to 1.9
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-001428.2.42 strain, at Day 182
|
5444.9 MFI
Interval 2974.9 to 9965.9
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-001428.2.42 strain, at Day 672
|
147.5 MFI
Interval 41.1 to 529.7
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-001428.2.42 strain, at Year 14
|
29.5 MFI
Interval 9.4 to 92.9
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-191084_B7 strain, at Day 0
|
1.4 MFI
Interval 0.9 to 2.1
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-191084_B7 strain, at Day 182
|
1272.5 MFI
Interval 308.2 to 5254.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-191084_B7 strain, at Day 672
|
98.2 MFI
Interval 22.6 to 426.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-191084_B7 strain, at Year 14
|
28.4 MFI
Interval 6.6 to 122.9
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-62357.14 strain, at Day 0
|
1.4 MFI
Interval 0.8 to 2.4
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-62357.14 strain, at Day 182
|
33.4 MFI
Interval 11.3 to 98.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-62357.14 strain, at Day 672
|
2.0 MFI
Interval 1.0 to 3.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-62357.14 strain, at Year 14
|
1.2 MFI
Interval 0.9 to 1.7
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-700010058 strain, at Day 0
|
1.4 MFI
Interval 0.9 to 2.1
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-700010058 strain, at Day 182
|
18048.6 MFI
Interval 12831.6 to 25386.6
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-700010058 strain, at Day 672
|
925.0 MFI
Interval 264.5 to 3235.1
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-700010058 strain, at Year 14
|
130.1 MFI
Interval 36.7 to 461.3
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-7060101641 strain, at Day 0
|
1.2 MFI
Interval 0.9 to 1.7
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-7060101641 strain, at Day 182
|
353.7 MFI
Interval 108.0 to 1157.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-7060101641 strain, at Day 672
|
23.5 MFI
Interval 6.8 to 81.0
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-7060101641 strain, at Year 14
|
13.4 MFI
Interval 4.4 to 40.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-96ZM651.02 strain, at Day 0
|
1.7 MFI
Interval 1.0 to 3.0
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-96ZM651.02 strain, at Day 182
|
777.3 MFI
Interval 286.8 to 2106.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-96ZM651.02 strain, at Day 672
|
11.2 MFI
Interval 3.7 to 33.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-96ZM651.02 strain, at Year 14
|
4.5 MFI
Interval 1.9 to 10.6
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-BF1266_431a strain, at Day 0
|
1.3 MFI
Interval 0.9 to 2.1
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-BF1266_431a strain, at Day 182
|
7838.7 MFI
Interval 3122.7 to 19676.7
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-BF1266_431a strain, at Day 672
|
414.6 MFI
Interval 90.9 to 1890.9
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-BF1266_431a strain, at Year 14
|
94.7 MFI
Interval 22.0 to 408.3
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-BJOX002000.03.2 strain, at Day 0
|
1.3 MFI
Interval 0.9 to 1.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-BJOX002000.03.2 strain, at Day 182
|
4033.1 MFI
Interval 1722.3 to 9444.1
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-BJOX002000.03.2 strain, at Day 672
|
113.7 MFI
Interval 30.5 to 424.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-BJOX002000.03.2 strain, at Year 14
|
22.3 MFI
Interval 6.6 to 75.3
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-C2101.c01 strain, at Day 0
|
1.3 MFI
Interval 0.9 to 1.6
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-C2101.c01 strain, at Day 182
|
1454.2 MFI
Interval 356.9 to 5925.2
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-C2101.c01 strain, at Day 672
|
85.0 MFI
Interval 17.1 to 422.6
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-C2101.c01 strain, at Year 14
|
28.7 MFI
Interval 6.2 to 131.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-CAP210.2.00.E8 strain, at Day 0
|
1.2 MFI
Interval 0.9 to 1.6
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-CAP210.2.00.E8 strain, at Day 182
|
5862.5 MFI
Interval 3157.3 to 10885.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-CAP210.2.00.E8 strain, at Day 672
|
150.2 MFI
Interval 40.6 to 556.2
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-CAP210.2.00.E8 strain, at Year 14
|
32.9 MFI
Interval 9.7 to 111.0
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-CM244.ec1 strain, at Day 0
|
1.6 MFI
Interval 0.9 to 2.6
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-Ce1086_B2 strain, at Day 182
|
2336.9 MFI
Interval 889.9 to 6136.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-Ce1086_B2 strain, at Day 672
|
82.8 MFI
Interval 20.9 to 328.6
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-Ce1086_B2 strain, at Year 14
|
23.4 MFI
Interval 6.6 to 83.3
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-RHPA4259.7 strain, at Day 0
|
1.5 MFI
Interval 0.9 to 2.4
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-RHPA4259.7 strain, at Day 182
|
2033.8 MFI
Interval 638.2 to 6481.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-RHPA4259.7 strain, at Day 672
|
30.4 MFI
Interval 8.9 to 103.9
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-RHPA4259.7 strain, at Year 14
|
6.5 MFI
Interval 2.5 to 17.1
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-TT31P.2F10.2792 strain, at Day 0
|
1.5 MFI
Interval 0.9 to 2.4
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-TT31P.2F10.2792 strain, at Day 182
|
10998.7 MFI
Interval 6967.0 to 17363.3
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-TT31P.2F10.2792 strain, at Day 672
|
312.7 MFI
Interval 82.8 to 1181.0
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-TT31P.2F10.2792 strain, at Year 14
|
71.9 MFI
Interval 20.9 to 247.8
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-TV1.21 strain, at Day 0
|
1.4 MFI
Interval 0.9 to 2.2
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-TV1.21 strain, at Day 182
|
10684.4 MFI
Interval 6527.9 to 17487.7
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-TV1.21 strain, at Day 672
|
382.4 MFI
Interval 108.3 to 1350.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70-TV1.21 strain, at Year 14
|
75.7 MFI
Interval 21.6 to 265.4
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70_B.CaseA strain, at Day 0
|
1.7 MFI
Interval 0.9 to 3.1
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70_B.CaseA strain, at Day 182
|
21647.6 MFI
Interval 16859.7 to 27795.3
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70_B.CaseA strain, at Day 672
|
1104.4 MFI
Interval 327.0 to 3730.2
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
gp70_B.CaseA strain, at Year 14
|
166.6 MFI
Interval 46.9 to 591.5
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags strain, at Day 0
|
1.2 MFI
Interval 0.8 to 1.9
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags strain, at Day 182
|
216.4 MFI
Interval 76.9 to 609.1
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags strain, at Day 672
|
15.1 MFI
Interval 5.8 to 39.6
|
|
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags strain, at Year 14
|
4.7 MFI
Interval 2.0 to 11.5
|
PRIMARY outcome
Timeframe: At Day 182, Day 672 historical time point of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. Antigen IgG3 was assessed for all strains. Antigens IgG1, IgG2 and IgG4 were assessed only for C.1086C\_V1\_V2 Tags strain that was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Outcome measures
| Measure |
GSKSB732461 Group
n=29 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-001428.2.42 IgG3 strain, at Day 182
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-001428.2.42 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-001428.2.42 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-191084_B7 IgG3 strain, at Day 182
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-191084_B7 IgG3 strain, at Day 672
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-191084_B7 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-62357.14 IgG3 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-62357.14 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-62357.14 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-700010058 IgG3 strain, at Day 182
|
3 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-700010058 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-700010058 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-7060101641 IgG3 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-7060101641 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-7060101641 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-96ZM651.02 IgG3 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-96ZM651.02 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-96ZM651.02 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-BF1266_431a IgG3 strain, at Day 182
|
5 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-BF1266_431a IgG3 strain, at Day 672
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-BF1266_431a IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-BJOX002000.03.2 IgG3 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-BJOX002000.03.2 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-BJOX002000.03.2 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-C2101.c01 IgG3 strain, at Day 182
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-C2101.c01 IgG3 strain, at Day 672
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-C2101.c01 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-CAP210.2.00.E8 IgG3 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-CAP210.2.00.E8 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-CAP210.2.00.E8 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-CM244.ec1 IgG3 strain, at Day 182
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-CM244.ec1 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-CM244.ec1 IgG3 strain, at Year 14
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-Ce1086_B2 IgG3 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-Ce1086_B2 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-Ce1086_B2 IgG3 strain, at Year 14
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-RHPA4259.7 IgG3 strain, at Day 182
|
3 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-RHPA4259.7 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-RHPA4259.7 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-TT31P.2F10.2792 IgG3 strain, at Day 182
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-TT31P.2F10.2792 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-TT31P.2F10.2792 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-TV1.21 IgG3 strain, at Day 182
|
3 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-TV1.21 IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70-TV1.21 IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70_B.CaseA IgG3 strain, at Day 182
|
11 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70_B.CaseA IgG3 strain, at Day 672
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
gp70_B.CaseA IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 182
|
15 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 672
|
5 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG1 Qual strain, at Year 14
|
2 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 182
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 672
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG2 Qual strain, at Year 14
|
1 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 182
|
5 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG3 Qual strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
C.1086C_V1_V2 Tags IgG4 Qual strain, at Year 14
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". Antigen IgG3 was assessed for all strains. Antigens IgG1, IgG2 and IgG4 were assessed only for C.1086C\_V1\_V2 Tags strain that was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Outcome measures
| Measure |
GSKSB732461 Group
n=34 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-001428.2.42 IgG3 strain, at Day 0
|
1.7 MFI
Interval 1.1 to 2.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-001428.2.42 IgG3 strain, at Day 182
|
2.6 MFI
Interval 1.5 to 4.4
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-001428.2.42 IgG3 strain, at Day 672
|
1.5 MFI
Interval 1.1 to 2.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-001428.2.42 IgG3 strain, at Year 14
|
1.4 MFI
Interval 1.0 to 1.9
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-191084_B7 IgG3 strain, at Day 0
|
1.5 MFI
Interval 1.1 to 2.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-191084_B7 IgG3 strain, at Day 182
|
4.6 MFI
Interval 2.6 to 8.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-191084_B7 IgG3 strain, at Day 672
|
1.6 MFI
Interval 1.1 to 2.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-191084_B7 IgG3 strain, at Year 14
|
2.8 MFI
Interval 1.8 to 4.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-62357.14 IgG3 strain, at Day 0
|
2.1 MFI
Interval 1.4 to 3.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-62357.14 IgG3 strain, at Day 182
|
1.2 MFI
Interval 1.0 to 1.4
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-62357.14 IgG3 strain, at Day 672
|
1.3 MFI
Interval 1.0 to 1.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-62357.14 IgG3 strain, at Year 14
|
4.1 MFI
Interval 2.8 to 6.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-700010058 IgG3 strain, at Day 0
|
1.2 MFI
Interval 1.0 to 1.4
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-700010058 IgG3 strain, at Day 182
|
11.9 MFI
Interval 6.3 to 22.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-700010058 IgG3 strain, at Day 672
|
1.3 MFI
Interval 1.0 to 1.9
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-700010058 IgG3 strain, at Year 14
|
2.9 MFI
Interval 1.9 to 4.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-7060101641 IgG3 strain, at Day 0
|
1.1 MFI
Interval 1.0 to 1.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-7060101641 IgG3 strain, at Day 182
|
3.7 MFI
Interval 2.4 to 5.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-7060101641 IgG3 strain, at Day 672
|
1.4 MFI
Interval 1.1 to 1.9
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-7060101641 IgG3 strain, at Year 14
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-96ZM651.02 IgG3 strain, at Day 0
|
1.4 MFI
Interval 1.0 to 2.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-96ZM651.02 IgG3 strain, at Day 182
|
1.8 MFI
Interval 1.2 to 2.8
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-96ZM651.02 IgG3 strain, at Day 672
|
1.2 MFI
Interval 0.9 to 1.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-96ZM651.02 IgG3 strain, at Year 14
|
1.6 MFI
Interval 1.1 to 2.3
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-BF1266_431a IgG3 strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-BF1266_431a IgG3 strain, at Day 182
|
13.2 MFI
Interval 6.1 to 28.5
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-BF1266_431a IgG3 strain, at Day 672
|
1.8 MFI
Interval 1.1 to 3.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-BF1266_431a IgG3 strain, at Year 14
|
1.5 MFI
Interval 1.0 to 2.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-BJOX002000.03.2 IgG3 strain, at Day 0
|
1.3 MFI
Interval 1.0 to 1.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-BJOX002000.03.2 IgG3 strain, at Day 182
|
4.7 MFI
Interval 2.9 to 7.7
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-BJOX002000.03.2 IgG3 strain, at Day 672
|
1.3 MFI
Interval 1.0 to 1.7
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-BJOX002000.03.2 IgG3 strain, at Year 14
|
1.6 MFI
Interval 1.2 to 2.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-C2101.c01 IgG3 strain, at Day 0
|
1.5 MFI
Interval 0.9 to 2.5
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-C2101.c01 IgG3 strain, at Day 182
|
4.7 MFI
Interval 2.4 to 9.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-C2101.c01 IgG3 strain, at Day 672
|
1.7 MFI
Interval 1.0 to 3.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-C2101.c01 IgG3 strain, at Year 14
|
1.9 MFI
Interval 1.2 to 3.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-CAP210.2.00.E8 IgG3 strain, at Day 0
|
1.5 MFI
Interval 1.0 to 2.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-CAP210.2.00.E8 IgG3 strain, at Day 182
|
5.9 MFI
Interval 3.6 to 9.5
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-CAP210.2.00.E8 IgG3 strain, at Day 672
|
1.6 MFI
Interval 1.1 to 2.3
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-CAP210.2.00.E8 IgG3 strain, at Year 14
|
2.1 MFI
Interval 1.5 to 3.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-CM244.ec1 IgG3 strain, at Day 0
|
1.5 MFI
Interval 1.0 to 2.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-CM244.ec1 IgG3 strain, at Day 182
|
4.5 MFI
Interval 2.7 to 7.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-CM244.ec1 IgG3 strain, at Day 672
|
1.5 MFI
Interval 1.1 to 2.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-CM244.ec1 IgG3 strain, at Year 14
|
4.0 MFI
Interval 2.5 to 6.5
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-Ce1086_B2 IgG3 strain, at Day 0
|
1.7 MFI
Interval 1.1 to 2.8
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-Ce1086_B2 IgG3 strain, at Day 182
|
3.0 MFI
Interval 1.8 to 5.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-Ce1086_B2 IgG3 strain, at Day 672
|
1.4 MFI
Interval 1.0 to 2.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-Ce1086_B2 IgG3 strain, at Year 14
|
1.4 MFI
Interval 0.9 to 2.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-RHPA4259.7 IgG3 strain, at Day 0
|
1.1 MFI
Interval 0.9 to 1.3
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-RHPA4259.7 IgG3 strain, at Day 182
|
4.0 MFI
Interval 2.0 to 7.9
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-RHPA4259.7 IgG3 strain, at Day 672
|
1.0 MFI
Interval 1.0 to 1.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-RHPA4259.7 IgG3 strain, at Year 14
|
1.2 MFI
Interval 1.0 to 1.5
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-TT31P.2F10.2792 IgG3 strain, at Day 0
|
1.3 MFI
Interval 1.0 to 1.7
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-TT31P.2F10.2792 IgG3 strain, at Day 182
|
9.9 MFI
Interval 5.7 to 16.9
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-TT31P.2F10.2792 IgG3 strain, at Day 672
|
1.5 MFI
Interval 1.1 to 2.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-TT31P.2F10.2792 IgG3 strain, at Year 14
|
1.1 MFI
Interval 1.0 to 1.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-TV1.21 IgG3 strain, at Day 0
|
1.6 MFI
Interval 0.9 to 2.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-TV1.21 IgG3 strain, at Day 182
|
11.4 MFI
Interval 5.8 to 22.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-TV1.21 IgG3 strain, at Day 672
|
1.9 MFI
Interval 1.2 to 3.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70-TV1.21 IgG3 strain, at Year 14
|
2.9 MFI
Interval 1.8 to 4.8
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70_B.CaseA IgG3 strain, at Day 0
|
1.2 MFI
Interval 0.8 to 1.7
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70_B.CaseA IgG3 strain, at Day 182
|
58.2 MFI
Interval 30.1 to 112.4
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70_B.CaseA IgG3 strain, at Day 672
|
2.8 MFI
Interval 1.4 to 5.3
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
gp70_B.CaseA IgG3 strain, at Year 14
|
1.7 MFI
Interval 1.1 to 2.8
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 0
|
1.2 MFI
Interval 0.8 to 2.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 182
|
89.4 MFI
Interval 31.0 to 258.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 672
|
7.4 MFI
Interval 3.1 to 18.0
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG1 Qual strain, at Year 14
|
2.4 MFI
Interval 1.3 to 4.7
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 0
|
1.1 MFI
Interval 1.0 to 1.2
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 182
|
1.4 MFI
Interval 0.9 to 2.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 672
|
1.4 MFI
Interval 0.9 to 2.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG2 Qual strain, at Year 14
|
1.3 MFI
Interval 0.9 to 1.9
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 0
|
1.8 MFI
Interval 1.2 to 2.7
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 182
|
5.0 MFI
Interval 2.2 to 11.1
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 672
|
1.3 MFI
Interval 1.0 to 1.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG3 Qual strain, at Year 14
|
2.1 MFI
Interval 1.6 to 2.8
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 0
|
1.2 MFI
Interval 1.0 to 1.4
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 182
|
1.3 MFI
Interval 1.1 to 1.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 672
|
1.3 MFI
Interval 1.1 to 1.6
|
|
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
C.1086C_V1_V2 Tags IgG4 Qual strain, at Year 14
|
1.0 MFI
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. The strains: 086C\_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG were not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Outcome measures
| Measure |
GSKSB732461 Group
n=29 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
254008_D11gp120.avi/293FIgGQual strain, at Day 182
|
29 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
254008_D11gp120.avi/293FIgGQual strain, at Day 672
|
29 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
254008_D11gp120.avi/293FIgGQual strain, at Year 14
|
27 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
51802_D11gp120.avi/293F IgGQual strain, at Day 182
|
25 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
51802_D11gp120.avi/293F IgGQual strain, at Day 672
|
18 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
51802_D11gp120.avi/293F IgGQual strain, at Year 14
|
6 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
A244 D11gp120_avi IgG Qual strain, at Day 182
|
25 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
A244 D11gp120_avi IgG Qual strain, at Day 672
|
20 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
A244 D11gp120_avi IgG Qual strain, at Year 14
|
8 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
B.6240_D11gp120/293F IgG Qual strain, at Day 182
|
27 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
B.6240_D11gp120/293F IgG Qual strain, at Day 672
|
23 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
B.6240_D11gp120/293F IgG Qual strain, at Year 14
|
17 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
BJOX002_D11gp120.avi/293FIgGQual strain,at Day 182
|
21 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
BJOX002_D11gp120.avi/293FIgGQual strain,at Day 672
|
13 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
BJOX002_D11gp120.avi/293FIgGQual strain,at Year 14
|
2 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
BORI_D11gp120.avi/293F IgG Qual strain, at Day 182
|
26 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
BORI_D11gp120.avi/293F IgG Qual strain, at Day 672
|
20 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
BORI_D11gp120.avi/293F IgG Qual strain, at Year 14
|
10 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
CNE20_D11gp120.avi/293F IgGQual strain, at Day 182
|
26 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
CNE20_D11gp120.avi/293F IgGQual strain, at Day 672
|
23 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
CNE20_D11gp120.avi/293F IgGQual strain, at Year 14
|
16 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
TT31P.2792_D11gp120.avi/293FIgGQual, at Day 182
|
27 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
TT31P.2792_D11gp120.avi/293FIgGQual, at Day 672
|
26 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
TT31P.2792_D11gp120.avi/293FIgGQual, at Year 14
|
20 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
1086C_D7gp120.avi/293F IgG strain, at Day 182
|
27 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
1086C_D7gp120.avi/293F IgG strain, at Day 672
|
27 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
1086C_D7gp120.avi/293F IgG strain, at Year 14
|
22 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
Con 6 gp120/B IgG strain, at Day 182
|
27 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
Con 6 gp120/B IgG strain, at Day 672
|
25 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
Con 6 gp120/B IgG strain, at Year 14
|
16 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
gp120 (Clone W6.1D) IgG strain, at Day 182
|
27 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
gp120 (Clone W6.1D) IgG strain, at Day 672
|
25 Participants
|
|
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
gp120 (Clone W6.1D) IgG strain, at Year 14
|
19 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". The strains: 086C\_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG were not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Outcome measures
| Measure |
GSKSB732461 Group
n=34 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
254008_D11gp120.avi/293F IgG -BKG strain, at Day 0
|
2.5 MFI
Interval 1.4 to 4.4
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
254008_D11gp120.avi/293FIgGQual strain, at Day 182
|
6796.7 MFI
Interval 5926.0 to 7795.3
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
254008_D11gp120.avi/293FIgGQual strain, at day 672
|
1633.3 MFI
Interval 1361.1 to 1959.9
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
254008_D11gp120.avi/293FIgGQual strain, at Year 14
|
479.6 MFI
Interval 308.7 to 745.3
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
51802_D11gp120.avi/293F IgG -BKG strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
51802_D11gp120.avi/293F IgGQual strain, at Day 182
|
993.7 MFI
Interval 407.4 to 2424.1
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
51802_D11gp120.avi/293F IgGQual strain, at Day 672
|
74.8 MFI
Interval 29.0 to 193.3
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
51802_D11gp120.avi/293F IgGQual strain, at Year 14
|
14.4 MFI
Interval 5.7 to 36.4
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
A244 D11gp120_avi IgG -BKG strain, at Day 0
|
1.4 MFI
Interval 0.9 to 2.2
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
A244 D11gp120_avi IgG Qual strain, at Day 182
|
990.2 MFI
Interval 498.3 to 1967.7
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
A244 D11gp120_avi IgG Qual strain, at Day 672
|
124.4 MFI
Interval 50.2 to 308.2
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
A244 D11gp120_avi IgG Qual strain, at Year 14
|
39.8 MFI
Interval 17.6 to 90.2
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
B.6240_D11gp120/293F IgG -BKG strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
B.6240_D11gp120/293F IgG Qual strain, at Day 182
|
8760.5 MFI
Interval 6725.8 to 11410.7
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
B.6240_D11gp120/293F IgG Qual strain, at Day 672
|
634.2 MFI
Interval 265.8 to 1513.3
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
B.6240_D11gp120/293F IgG Qual strain, at Year 14
|
132.8 MFI
Interval 53.6 to 329.1
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
BJOX002_D11gp120.avi/293F IgG-BKG strain, at Day 0
|
1.1 MFI
Interval 0.9 to 1.3
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
BJOX002_D11gp120.avi/293FIgGQual strain,at Day 182
|
250.6 MFI
Interval 109.9 to 571.6
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
BJOX002_D11gp120.avi/293FIgGQual strain,at Day 672
|
31.2 MFI
Interval 13.8 to 70.6
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
BJOX002_D11gp120.avi/293FIgGQual strain,at Year 14
|
9.9 MFI
Interval 4.5 to 21.9
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
BORI_D11gp120.avi/293F IgG -BKG strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
BORI_D11gp120.avi/293F IgG Qual strain, at Day 182
|
2811.9 MFI
Interval 1546.5 to 5112.6
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
BORI_D11gp120.avi/293F IgG Qual strain, at Day 672
|
148.9 MFI
Interval 57.1 to 388.5
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
BORI_D11gp120.avi/293F IgG Qual strain, at Year 14
|
35.5 MFI
Interval 13.8 to 91.4
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
CNE20_D11gp120.avi/293F IgG -BKG strain, at Day 0
|
1.1 MFI
Interval 0.9 to 1.5
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
CNE20_D11gp120.avi/293F IgGQual strain, at Day 182
|
2925.8 MFI
Interval 1336.2 to 6406.5
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
CNE20_D11gp120.avi/293F IgGQual strain, at Day 672
|
587.3 MFI
Interval 295.6 to 1166.9
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
CNE20_D11gp120.avi/293F IgGQual strain, at Year 14
|
126.0 MFI
Interval 55.6 to 285.5
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
TT31P.2792_D11gp120.avi/293FIgGBKG strain,at Day 0
|
1.6 MFI
Interval 0.9 to 2.7
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
TT31P.2792_D11gp120.avi/293FIgGQual, at Day 182
|
20622.9 MFI
Interval 18541.3 to 22938.2
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
TT31P.2792_D11gp120.avi/293FIgGQual, at Day 672
|
3372.5 MFI
Interval 1788.3 to 6360.1
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
TT31P.2792_D11gp120.avi/293FIgGQual, at Year 14
|
568.6 MFI
Interval 253.3 to 1276.5
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
1086C_D7gp120.avi/293F IgG strain, at Day 0
|
1.1 MFI
Interval 0.9 to 1.4
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
1086C_D7gp120.avi/293F IgG strain, at Day 182
|
27145.5 MFI
Interval 26416.5 to 27894.7
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
1086C_D7gp120.avi/293F IgG strain, at Day 672
|
17448.6 MFI
Interval 14249.1 to 21366.6
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
1086C_D7gp120.avi/293F IgG strain, at Year 14
|
4253.8 MFI
Interval 3218.3 to 5622.4
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
Con 6 gp120/B IgG strain, at Day 0
|
1.8 MFI
Interval 1.2 to 2.6
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
Con 6 gp120/B IgG strain, at Day 182
|
10618.0 MFI
Interval 8540.0 to 13201.6
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
Con 6 gp120/B IgG strain, at Day 672
|
879.2 MFI
Interval 422.1 to 1831.4
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
Con 6 gp120/B IgG strain, at Year 14
|
176.8 MFI
Interval 76.6 to 408.1
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
gp120 (Clone W6.1D) IgG strain, at Day 0
|
1.1 MFI
Interval 0.9 to 1.3
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
gp120 (Clone W6.1D) IgG strain, at Day 182
|
25617.4 MFI
Interval 24497.6 to 26788.4
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
gp120 (Clone W6.1D) IgG strain, at Day 672
|
3027.1 MFI
Interval 1293.7 to 7083.2
|
|
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
gp120 (Clone W6.1D) IgG strain, at Year 14
|
544.6 MFI
Interval 236.5 to 1253.7
|
SECONDARY outcome
Timeframe: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline.Analysis was performed on the gp120 antigen (IgG1, IgG2, IgG3 and IgG4) for the following vaccine HIV strains which were not part of any breadth panel: 1086C\_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Outcome measures
| Measure |
GSKSB732461 Group
n=29 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG1 strain, at Day 182
|
28 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG1 strain, at Day 672
|
27 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG1 strain, at Year 14
|
23 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG1 strain, at Day 182
|
28 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG1 strain, at Day 672
|
22 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG1 strain, at Year 14
|
11 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG1 strain, at Day 182
|
28 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG1 strain, at Day 672
|
25 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG1 strain, at Year 14
|
16 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG2 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG2 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG2 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG2 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG2 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG2 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG2 strain, at Day 182
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG2 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG2 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG3 strain, at Day 182
|
25 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG3 strain, at Day 672
|
21 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG3 strain, at Year 14
|
9 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG3 strain, at Day 182
|
9 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG3 strain, at Day 672
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG3 strain, at Year 14
|
0 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG3 strain, at Day 182
|
19 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG3 strain, at Day 672
|
3 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG3 strain, at Year 14
|
1 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG4 strain, at Day 182
|
6 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG4 strain, at Day 672
|
5 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG4 strain, at Year 14
|
7 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG4 strain, at Day 182
|
1 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG4 strain, at Day 672
|
2 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG4 strain, at Year 14
|
2 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG4 strain, at Day 182
|
8 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG4 strain, at Day 672
|
3 Participants
|
|
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG4 strain, at Year 14
|
3 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". Analysis was performed on the gp120 antigen (IgG1, IgG2, IgG3 and IgG4) for the following vaccine HIV strains: which were not part of any breadth panel: 1086C\_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Outcome measures
| Measure |
GSKSB732461 Group
n=34 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG1 strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG1 strain, at Day 182
|
10365.4 MFI
Interval 9153.8 to 11737.5
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG1 strain, at Day 672
|
2834.1 MFI
Interval 1991.6 to 4033.1
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG1 strain, at Year 14
|
371.0 MFI
Interval 158.9 to 866.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG1 strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.1
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG1 strain, at Day 182
|
4396.8 MFI
Interval 3618.2 to 5343.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG1 strain, at Day 672
|
246.0 MFI
Interval 95.6 to 632.9
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG1 strain, at Year 14
|
21.5 MFI
Interval 8.2 to 55.9
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG1 strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG1 strain, at Day 182
|
11572.9 MFI
Interval 9525.5 to 14060.3
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG1 strain, at Day 672
|
653.3 MFI
Interval 359.5 to 1187.2
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG1 strain, at Year 14
|
47.0 MFI
Interval 18.1 to 122.1
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG2 strain, at Day 0
|
1.2 MFI
Interval 1.1 to 1.4
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG2 strain, at Day 182
|
2.6 MFI
Interval 1.7 to 3.9
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG2 strain, at Day 672
|
2.4 MFI
Interval 1.6 to 3.6
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG2 strain, at Year 14
|
1.1 MFI
Interval 1.0 to 1.2
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG2 strain, at Day 0
|
1.1 MFI
Interval 1.0 to 1.2
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG2 strain, at Day 182
|
1.3 MFI
Interval 1.1 to 1.6
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG2 strain, at Day 672
|
1.4 MFI
Interval 1.1 to 1.7
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG2 strain, at Year 14
|
1.3 MFI
Interval 1.1 to 1.6
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG2 strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG2 strain, at Day 182
|
1.9 MFI
Interval 1.3 to 2.9
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG2 strain, at Day 672
|
1.5 MFI
Interval 1.1 to 2.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG2 strain, at Year 14
|
1.1 MFI
Interval 0.9 to 1.4
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG3 strain, at Day 0
|
1.5 MFI
Interval 1.1 to 2.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG3 strain, at Day 182
|
417.1 MFI
Interval 302.7 to 574.8
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG3 strain, at Day 672
|
206.3 MFI
Interval 150.4 to 283.1
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG3 strain, at Year 14
|
42.8 MFI
Interval 22.4 to 81.8
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG3 strain, at Day 0
|
1.1 MFI
Interval 1.0 to 1.2
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG3 strain, at Day 182
|
60.8 MFI
Interval 41.5 to 89.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG3 strain, at Day 672
|
11.0 MFI
Interval 6.5 to 18.6
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG3 strain, at Year 14
|
2.9 MFI
Interval 1.9 to 4.3
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG3 strain, at Day 0
|
1.1 MFI
Interval 1.0 to 1.2
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG3 strain, at Day 182
|
161.9 MFI
Interval 111.2 to 235.6
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG3 strain, at Day 672
|
24.3 MFI
Interval 14.7 to 40.3
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG3 strain, at Year 14
|
7.8 MFI
Interval 4.3 to 14.3
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG4 strain, at Day 0
|
1.2 MFI
Interval 1.0 to 1.4
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG4 strain, at Day 182
|
47.0 MFI
Interval 30.4 to 72.7
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG4 strain, at Day 672
|
30.1 MFI
Interval 16.9 to 53.6
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
1086C_D7gp120.avi/293F IgG4 strain, at Year 14
|
20.3 MFI
Interval 9.9 to 41.5
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG4 strain, at Day 0
|
1.0 MFI
Interval 1.0 to 1.0
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG4 strain, at Day 182
|
14.9 MFI
Interval 9.7 to 22.7
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG4 strain, at Day 672
|
6.6 MFI
Interval 3.9 to 11.3
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
Con 6 gp120/B IgG4 strain, at Year 14
|
4.7 MFI
Interval 2.5 to 8.6
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG4 strain, at Day 0
|
1.1 MFI
Interval 1.0 to 1.2
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG4 strain, at Day 182
|
52.8 MFI
Interval 36.7 to 75.8
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG4 strain, at Day 672
|
21.3 MFI
Interval 12.9 to 35.3
|
|
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
gp120 (Clone W6.1D) IgG4 strain, at Year 14
|
10.4 MFI
Interval 5.8 to 18.8
|
SECONDARY outcome
Timeframe: At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
Assessed cytokines include: cluster of differentiation-40 lingand (CD40-L), Interleukin-2 (IL2), Tumour Necrosis Factor-alpha (TNF-α), Interferon-gamma (INF-γ), by Intracellular Cytokine Staining (ICS). CD4+ T-cells were expressed in CD4+ T-cells/million cells.
Outcome measures
| Measure |
GSKSB732461 Group
n=33 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers
At Day 0
|
0.00 CD4+ T-cells/million cells
Interval 0.0 to 0.01
|
|
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers
At Day 98
|
0.42 CD4+ T-cells/million cells
Interval 0.3 to 0.78
|
|
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers
At Day 672
|
0.32 CD4+ T-cells/million cells
Interval 0.21 to 0.43
|
|
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers
At Year 14
|
0.21 CD4+ T-cells/million cells
Interval 0.14 to 0.35
|
SECONDARY outcome
Timeframe: At Day 98 and at Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
Vaccine response rates for HIV-1-specific CD4+ T cells expressing at least two markers among CD40L, IL-2, TNF-α and IFN-γ with responders were defined as subjects with: a 2-fold increase as compared to the cut-off (=354, limit of quantification \[LOQ\] of the assay), for subjects with pre-vaccination frequency below the cut-off, at Day 0, OR at least 2-fold increase as compared to pre-vaccination frequency, for subjects with pre-vaccination frequency above the cut-off.
Outcome measures
| Measure |
GSKSB732461 Group
n=26 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers
At Day 98
|
25 Participants
|
|
Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers
At Day 672
|
23 Participants
|
|
Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers
At Year 14
|
22 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
Assessed cytokines include: CD40-L, IL2, TNF-α, INF-γ, by ICS. CD8+ T-cells were expressed in CD8+ T-cells/million cells/million cells.
Outcome measures
| Measure |
GSKSB732461 Group
n=33 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
|
|---|---|
|
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
At Day 0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 0.01
|
|
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
At Day 98
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 0.01
|
|
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
At Day 672
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 0.01
|
|
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
At Year 14
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 0.01
|
SECONDARY outcome
Timeframe: At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14Population: Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.
Vaccine response rates for HIV-1-specific CD8+ T cells expressing at least two markers among CD40L, IL-2, TNF-α and IFN-γ with responders were defined as subjects with: a 2-fold increase as compared to the cut-off (=354, limit of quantification \[LOQ\] of the assay), for subjects with pre-vaccination frequency below the cut-off, at Day 0, OR at least 2-fold increase as compared to pre- vaccination frequency, for subjects with pre-vaccination frequency above the cut-off.
Outcome measures
| Measure |
GSKSB732461 Group
n=33 Participants
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
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|---|---|
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Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
At Day 98
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0 Participants
|
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Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
At Day 672
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0 Participants
|
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Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
At Year 14
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0 Participants
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Adverse Events
GSKSB732461 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER