Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT03368053
Collaborator
University Ghent (Other)
36
1
1
1.5
23.3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the long-term persistence of binding antibody responses against V1V2 and gp120 in subjects who were vaccinated with the envelope glycoprotein 120 (gp120)-negative factor (Nef)Tat/ Adjuvant System 01B (AS01B) (GSKSB732461) vaccine candidate. Other immune parameters like the HIV-specific cluster of differentiation (CD4+) T cell and CD8+ T cell responses will also be evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
GlaxoSmithKline (GSK) contributes to the public-private pox-protein partnership (P5) which is currently assessing the safety, immunogenicity and clinical efficacy of a prime-boost regimen aimed at preventing HIV transmission (http://www.hvtn.org/en.html). The booster component of the candidate vaccine used in this program consists of two gp120 clade C proteins administered with an adjuvant. In order to inform the selection of the adjuvant in future studies, data on long-term persistence of immunity after vaccination with gp120/AS01 would prove useful. The present study was designed to address this question using a cohort of volunteers vaccinated several years ago with a candidate vaccine containing gp120 and AS01.
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Descriptive mono-centric study with one single group.Descriptive mono-centric study with one single group.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Actual Study Start Date
:
Dec 14, 2017
Actual Primary Completion Date
:
Jan 30, 2018
Actual Study Completion Date
:
Jan 30, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Procedure: Blood sampling
Blood samples will be taken during the single study visit at Year 14 for the assessment of: HIV testing, antibody determination, cell mediated immune (CMI) responses and exploratory characterisation.
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call [At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- Anti-V1V2 Total IgG Antibody BAMA Response Magnitude [At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call [At Day 182, Day 672 historical time point of PRO-HIV-002 and at Year 14]
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.
- Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude [At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
Secondary Outcome Measures
- Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call [At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- Anti-gp 120 Total IgG Antibody BAMA Response Magnitude [At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel [At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel [At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- 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, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers [At Day 98 and at Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers [At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
- Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers [At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
-
Written informed consent obtained from the subject prior to performing any study specific procedure.
-
A subject who has received at least 3 doses of the gp120-NefTat/AS01B (GSKSB732461) vaccine candidate in GSK Biologicals-sponsored PRO HIV-002 study.
Exclusion Criteria:
-
Use of any investigational or non-registered product during 30 days prior to study enrolment.
-
History of HIV-1 or HIV-2 infection.
-
Participation to another clinical trial of an investigational HIV vaccine between study PRO HIV-002 and the present study.
-
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting one month preceding this study. For corticosteroids, this will mean prednisone higher than or equal to (≥) 20 mg/day . Inhaled and topical steroids are allowed.
-
Administration of cytotoxic medication within 6 months preceding this study.
-
History of daily, long-term immunosuppressive medication between study PRO HIV-002 and the present study.
-
Administration of immunoglobulins and/or any blood products during the period starting 3 months before enrolment.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition other than HIV disease, based on medical history and physical examination between study PRO HIV-002 and the present study.
-
Past administration of an investigational vaccine containing AS01 other than the gp120-NefTat/AS01B (GSKSB732461) vaccine administered in PRO HIV-002 study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Gent | Belgium | 9000 |
Sponsors and Collaborators
- GlaxoSmithKline
- University Ghent
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT03368053
Other Study ID Numbers:
- 201606
First Posted:
Dec 11, 2017
Last Update Posted:
Oct 20, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study was conducted at one Centre in Belgium. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 36 |
| COMPLETED | 36 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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 Participants | 36 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
43.5
(8.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
13
36.1%
|
| Male |
23
63.9%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| WHITE - CAUCASIAN / EUROPEAN HERITAGE |
35
97.2%
|
| BLACK OR AFRICAN AMERICAN |
1
2.8%
|
Outcome Measures
| Title | Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call |
|---|---|
| Description | 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. |
| Time Frame | At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 27 |
| gp70-001428.2.42 strain, at Day 182 |
25
69.4%
|
| gp70-001428.2.42 strain, at Day 672 |
15
41.7%
|
| gp70-001428.2.42 strain, at Year 14 |
8
22.2%
|
| gp70-191084_B7 strain, at Day 182 |
20
55.6%
|
| gp70-191084_B7 strain, at Day 672 |
12
33.3%
|
| gp70-191084_B7 strain, at Year 14 |
9
25%
|
| gp70-62357.14 strain, at Day 182 |
12
33.3%
|
| gp70-62357.14 strain, at Day 672 |
1
2.8%
|
| gp70-62357.14 strain, at Year 14 |
0
0%
|
| gp70-700010058 strain, at Day 182 |
26
72.2%
|
| gp70-700010058 strain, at Day 672 |
19
52.8%
|
| gp70-700010058 strain, at Year 14 |
13
36.1%
|
| gp70-7060101641 strain, at Day 182 |
18
50%
|
| gp70-7060101641 strain, at Day 672 |
9
25%
|
| gp70-7060101641 strain, at Year 14 |
4
11.1%
|
| gp70-96ZM651.02 strain, at Day 182 |
21
58.3%
|
| gp70-96ZM651.02 strain, at Day 672 |
4
11.1%
|
| gp70-96ZM651.02 strain, at Year 14 |
2
5.6%
|
| gp70-BF1266_431a strain, at Day 182 |
24
66.7%
|
| gp70-BF1266_431a strain, at Day 672 |
16
44.4%
|
| gp70-BF1266_431a strain, at Year 14 |
11
30.6%
|
| gp70-BJOX002000.03.2 strain, at Day 182 |
24
66.7%
|
| gp70-BJOX002000.03.2 strain, at Day 672 |
14
38.9%
|
| gp70-BJOX002000.03.2 strain, at Year 14 |
6
16.7%
|
| gp70-C2101.c01 strain, at Day 182 |
20
55.6%
|
| gp70-C2101.c01 strain, at Day 672 |
12
33.3%
|
| gp70-C2101.c01 strain, at Year 14 |
8
22.2%
|
| gp70-CAP210.2.00.E8 strain, at Day 182 |
26
72.2%
|
| gp70-CAP210.2.00.E8 strain, at Day 672 |
15
41.7%
|
| gp70-CAP210.2.00.E8 strain, at Year 14 |
7
19.4%
|
| gp70-CM244.ec1 strain, Day 182 |
22
61.1%
|
| gp70-CM244.ec1 strain, at Day 672 |
13
36.1%
|
| gp70-CM244.ec1 strain, at Year 14 |
7
19.4%
|
| gp70-Ce1086_B2 strain, at Day 182 |
23
63.9%
|
| gp70-Ce1086_B2 strain, at Day 672 |
14
38.9%
|
| gp70-Ce1086_B2 strain, at Year 14 |
6
16.7%
|
| gp70-RHPA4259.7 strain, at Day 182 |
22
61.1%
|
| gp70-RHPA4259.7 strain, at Day 672 |
9
25%
|
| gp70-RHPA4259.7 strain, at Year 14 |
2
5.6%
|
| gp70-TT31P.2F10.2792 strain, at Day 182 |
26
72.2%
|
| gp70-TT31P.2F10.2792 strain, at Day 672 |
18
50%
|
| gp70-TT31P.2F10.2792 strain, at Year 14 |
10
27.8%
|
| gp70-TV1.21 strain, at Day 182 |
26
72.2%
|
| gp70-TV1.21 strain, at Day 672 |
18
50%
|
| gp70-TV1.21 strain, at Year 14 |
9
25%
|
| gp70_B.CaseA strain, at Day 182 |
26
72.2%
|
| gp70_B.CaseA strain, at Day 672 |
21
58.3%
|
| gp70_B.CaseA strain, at Year 14 |
12
33.3%
|
| C.1086C_V1_V2 Tags strain, at Day 182 |
19
52.8%
|
| C.1086C_V1_V2 Tags strain, at Day 672 |
5
13.9%
|
| C.1086C_V1_V2 Tags strain, at Year 14 |
3
8.3%
|
| Title | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude |
|---|---|
| Description | 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. |
| Time Frame | At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 32 |
| gp70-001428.2.42 strain, at Day 0 |
1.3
|
| gp70-001428.2.42 strain, at Day 182 |
5444.9
|
| gp70-001428.2.42 strain, at Day 672 |
147.5
|
| gp70-001428.2.42 strain, at Year 14 |
29.5
|
| gp70-191084_B7 strain, at Day 0 |
1.4
|
| gp70-191084_B7 strain, at Day 182 |
1272.5
|
| gp70-191084_B7 strain, at Day 672 |
98.2
|
| gp70-191084_B7 strain, at Year 14 |
28.4
|
| gp70-62357.14 strain, at Day 0 |
1.4
|
| gp70-62357.14 strain, at Day 182 |
33.4
|
| gp70-62357.14 strain, at Day 672 |
2.0
|
| gp70-62357.14 strain, at Year 14 |
1.2
|
| gp70-700010058 strain, at Day 0 |
1.4
|
| gp70-700010058 strain, at Day 182 |
18048.6
|
| gp70-700010058 strain, at Day 672 |
925.0
|
| gp70-700010058 strain, at Year 14 |
130.1
|
| gp70-7060101641 strain, at Day 0 |
1.2
|
| gp70-7060101641 strain, at Day 182 |
353.7
|
| gp70-7060101641 strain, at Day 672 |
23.5
|
| gp70-7060101641 strain, at Year 14 |
13.4
|
| gp70-96ZM651.02 strain, at Day 0 |
1.7
|
| gp70-96ZM651.02 strain, at Day 182 |
777.3
|
| gp70-96ZM651.02 strain, at Day 672 |
11.2
|
| gp70-96ZM651.02 strain, at Year 14 |
4.5
|
| gp70-BF1266_431a strain, at Day 0 |
1.3
|
| gp70-BF1266_431a strain, at Day 182 |
7838.7
|
| gp70-BF1266_431a strain, at Day 672 |
414.6
|
| gp70-BF1266_431a strain, at Year 14 |
94.7
|
| gp70-BJOX002000.03.2 strain, at Day 0 |
1.3
|
| gp70-BJOX002000.03.2 strain, at Day 182 |
4033.1
|
| gp70-BJOX002000.03.2 strain, at Day 672 |
113.7
|
| gp70-BJOX002000.03.2 strain, at Year 14 |
22.3
|
| gp70-C2101.c01 strain, at Day 0 |
1.3
|
| gp70-C2101.c01 strain, at Day 182 |
1454.2
|
| gp70-C2101.c01 strain, at Day 672 |
85.0
|
| gp70-C2101.c01 strain, at Year 14 |
28.7
|
| gp70-CAP210.2.00.E8 strain, at Day 0 |
1.2
|
| gp70-CAP210.2.00.E8 strain, at Day 182 |
5862.5
|
| gp70-CAP210.2.00.E8 strain, at Day 672 |
150.2
|
| gp70-CAP210.2.00.E8 strain, at Year 14 |
32.9
|
| gp70-CM244.ec1 strain, at Day 0 |
1.6
|
| gp70-CM244.ec1 strain, at Day 182 |
2770.8
|
| gp70-CM244.ec1 strain, at Day 672 |
98.6
|
| gp70-CM244.ec strain, at Year 14 |
33.0
|
| gp70-Ce1086_B2 strain, at Day 0 |
1.3
|
| gp70-Ce1086_B2 strain, at Day 182 |
2336.9
|
| gp70-Ce1086_B2 strain, at Day 672 |
82.8
|
| gp70-Ce1086_B2 strain, at Year 14 |
23.4
|
| gp70-RHPA4259.7 strain, at Day 0 |
1.5
|
| gp70-RHPA4259.7 strain, at Day 182 |
2033.8
|
| gp70-RHPA4259.7 strain, at Day 672 |
30.4
|
| gp70-RHPA4259.7 strain, at Year 14 |
6.5
|
| gp70-TT31P.2F10.2792 strain, at Day 0 |
1.5
|
| gp70-TT31P.2F10.2792 strain, at Day 182 |
10998.7
|
| gp70-TT31P.2F10.2792 strain, at Day 672 |
312.7
|
| gp70-TT31P.2F10.2792 strain, at Year 14 |
71.9
|
| gp70-TV1.21 strain, at Day 0 |
1.4
|
| gp70-TV1.21 strain, at Day 182 |
10684.4
|
| gp70-TV1.21 strain, at Day 672 |
382.4
|
| gp70-TV1.21 strain, at Year 14 |
75.7
|
| gp70_B.CaseA strain, at Day 0 |
1.7
|
| gp70_B.CaseA strain, at Day 182 |
21647.6
|
| gp70_B.CaseA strain, at Day 672 |
1104.4
|
| gp70_B.CaseA strain, at Year 14 |
166.6
|
| C.1086C_V1_V2 Tags strain, at Day 0 |
1.2
|
| C.1086C_V1_V2 Tags strain, at Day 182 |
216.4
|
| C.1086C_V1_V2 Tags strain, at Day 672 |
15.1
|
| C.1086C_V1_V2 Tags strain, at Year 14 |
4.7
|
| Title | Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call |
|---|---|
| Description | 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. |
| Time Frame | At Day 182, Day 672 historical time point of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 29 |
| gp70-001428.2.42 IgG3 strain, at Day 182 |
2
5.6%
|
| gp70-001428.2.42 IgG3 strain, at Day 672 |
0
0%
|
| gp70-001428.2.42 IgG3 strain, at Year 14 |
0
0%
|
| gp70-191084_B7 IgG3 strain, at Day 182 |
2
5.6%
|
| gp70-191084_B7 IgG3 strain, at Day 672 |
1
2.8%
|
| gp70-191084_B7 IgG3 strain, at Year 14 |
0
0%
|
| gp70-62357.14 IgG3 strain, at Day 182 |
0
0%
|
| gp70-62357.14 IgG3 strain, at Day 672 |
0
0%
|
| gp70-62357.14 IgG3 strain, at Year 14 |
0
0%
|
| gp70-700010058 IgG3 strain, at Day 182 |
3
8.3%
|
| gp70-700010058 IgG3 strain, at Day 672 |
0
0%
|
| gp70-700010058 IgG3 strain, at Year 14 |
0
0%
|
| gp70-7060101641 IgG3 strain, at Day 182 |
0
0%
|
| gp70-7060101641 IgG3 strain, at Day 672 |
0
0%
|
| gp70-7060101641 IgG3 strain, at Year 14 |
0
0%
|
| gp70-96ZM651.02 IgG3 strain, at Day 182 |
0
0%
|
| gp70-96ZM651.02 IgG3 strain, at Day 672 |
0
0%
|
| gp70-96ZM651.02 IgG3 strain, at Year 14 |
0
0%
|
| gp70-BF1266_431a IgG3 strain, at Day 182 |
5
13.9%
|
| gp70-BF1266_431a IgG3 strain, at Day 672 |
2
5.6%
|
| gp70-BF1266_431a IgG3 strain, at Year 14 |
0
0%
|
| gp70-BJOX002000.03.2 IgG3 strain, at Day 182 |
0
0%
|
| gp70-BJOX002000.03.2 IgG3 strain, at Day 672 |
0
0%
|
| gp70-BJOX002000.03.2 IgG3 strain, at Year 14 |
0
0%
|
| gp70-C2101.c01 IgG3 strain, at Day 182 |
2
5.6%
|
| gp70-C2101.c01 IgG3 strain, at Day 672 |
1
2.8%
|
| gp70-C2101.c01 IgG3 strain, at Year 14 |
0
0%
|
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 182 |
0
0%
|
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 672 |
0
0%
|
| gp70-CAP210.2.00.E8 IgG3 strain, at Year 14 |
0
0%
|
| gp70-CM244.ec1 IgG3 strain, at Day 182 |
1
2.8%
|
| gp70-CM244.ec1 IgG3 strain, at Day 672 |
0
0%
|
| gp70-CM244.ec1 IgG3 strain, at Year 14 |
1
2.8%
|
| gp70-Ce1086_B2 IgG3 strain, at Day 182 |
0
0%
|
| gp70-Ce1086_B2 IgG3 strain, at Day 672 |
0
0%
|
| gp70-Ce1086_B2 IgG3 strain, at Year 14 |
1
2.8%
|
| gp70-RHPA4259.7 IgG3 strain, at Day 182 |
3
8.3%
|
| gp70-RHPA4259.7 IgG3 strain, at Day 672 |
0
0%
|
| gp70-RHPA4259.7 IgG3 strain, at Year 14 |
0
0%
|
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 182 |
2
5.6%
|
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 672 |
0
0%
|
| gp70-TT31P.2F10.2792 IgG3 strain, at Year 14 |
0
0%
|
| gp70-TV1.21 IgG3 strain, at Day 182 |
3
8.3%
|
| gp70-TV1.21 IgG3 strain, at Day 672 |
0
0%
|
| gp70-TV1.21 IgG3 strain, at Year 14 |
0
0%
|
| gp70_B.CaseA IgG3 strain, at Day 182 |
11
30.6%
|
| gp70_B.CaseA IgG3 strain, at Day 672 |
2
5.6%
|
| gp70_B.CaseA IgG3 strain, at Year 14 |
0
0%
|
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 182 |
15
41.7%
|
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 672 |
5
13.9%
|
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Year 14 |
2
5.6%
|
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 182 |
1
2.8%
|
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 672 |
1
2.8%
|
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Year 14 |
1
2.8%
|
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 182 |
5
13.9%
|
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 672 |
0
0%
|
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Year 14 |
0
0%
|
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 182 |
0
0%
|
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 672 |
0
0%
|
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Year 14 |
0
0%
|
| Title | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude |
|---|---|
| Description | 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. |
| Time Frame | At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 34 |
| gp70-001428.2.42 IgG3 strain, at Day 0 |
1.7
|
| gp70-001428.2.42 IgG3 strain, at Day 182 |
2.6
|
| gp70-001428.2.42 IgG3 strain, at Day 672 |
1.5
|
| gp70-001428.2.42 IgG3 strain, at Year 14 |
1.4
|
| gp70-191084_B7 IgG3 strain, at Day 0 |
1.5
|
| gp70-191084_B7 IgG3 strain, at Day 182 |
4.6
|
| gp70-191084_B7 IgG3 strain, at Day 672 |
1.6
|
| gp70-191084_B7 IgG3 strain, at Year 14 |
2.8
|
| gp70-62357.14 IgG3 strain, at Day 0 |
2.1
|
| gp70-62357.14 IgG3 strain, at Day 182 |
1.2
|
| gp70-62357.14 IgG3 strain, at Day 672 |
1.3
|
| gp70-62357.14 IgG3 strain, at Year 14 |
4.1
|
| gp70-700010058 IgG3 strain, at Day 0 |
1.2
|
| gp70-700010058 IgG3 strain, at Day 182 |
11.9
|
| gp70-700010058 IgG3 strain, at Day 672 |
1.3
|
| gp70-700010058 IgG3 strain, at Year 14 |
2.9
|
| gp70-7060101641 IgG3 strain, at Day 0 |
1.1
|
| gp70-7060101641 IgG3 strain, at Day 182 |
3.7
|
| gp70-7060101641 IgG3 strain, at Day 672 |
1.4
|
| gp70-7060101641 IgG3 strain, at Year 14 |
1.0
|
| gp70-96ZM651.02 IgG3 strain, at Day 0 |
1.4
|
| gp70-96ZM651.02 IgG3 strain, at Day 182 |
1.8
|
| gp70-96ZM651.02 IgG3 strain, at Day 672 |
1.2
|
| gp70-96ZM651.02 IgG3 strain, at Year 14 |
1.6
|
| gp70-BF1266_431a IgG3 strain, at Day 0 |
1.0
|
| gp70-BF1266_431a IgG3 strain, at Day 182 |
13.2
|
| gp70-BF1266_431a IgG3 strain, at Day 672 |
1.8
|
| gp70-BF1266_431a IgG3 strain, at Year 14 |
1.5
|
| gp70-BJOX002000.03.2 IgG3 strain, at Day 0 |
1.3
|
| gp70-BJOX002000.03.2 IgG3 strain, at Day 182 |
4.7
|
| gp70-BJOX002000.03.2 IgG3 strain, at Day 672 |
1.3
|
| gp70-BJOX002000.03.2 IgG3 strain, at Year 14 |
1.6
|
| gp70-C2101.c01 IgG3 strain, at Day 0 |
1.5
|
| gp70-C2101.c01 IgG3 strain, at Day 182 |
4.7
|
| gp70-C2101.c01 IgG3 strain, at Day 672 |
1.7
|
| gp70-C2101.c01 IgG3 strain, at Year 14 |
1.9
|
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 0 |
1.5
|
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 182 |
5.9
|
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 672 |
1.6
|
| gp70-CAP210.2.00.E8 IgG3 strain, at Year 14 |
2.1
|
| gp70-CM244.ec1 IgG3 strain, at Day 0 |
1.5
|
| gp70-CM244.ec1 IgG3 strain, at Day 182 |
4.5
|
| gp70-CM244.ec1 IgG3 strain, at Day 672 |
1.5
|
| gp70-CM244.ec1 IgG3 strain, at Year 14 |
4.0
|
| gp70-Ce1086_B2 IgG3 strain, at Day 0 |
1.7
|
| gp70-Ce1086_B2 IgG3 strain, at Day 182 |
3.0
|
| gp70-Ce1086_B2 IgG3 strain, at Day 672 |
1.4
|
| gp70-Ce1086_B2 IgG3 strain, at Year 14 |
1.4
|
| gp70-RHPA4259.7 IgG3 strain, at Day 0 |
1.1
|
| gp70-RHPA4259.7 IgG3 strain, at Day 182 |
4.0
|
| gp70-RHPA4259.7 IgG3 strain, at Day 672 |
1.0
|
| gp70-RHPA4259.7 IgG3 strain, at Year 14 |
1.2
|
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 0 |
1.3
|
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 182 |
9.9
|
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 672 |
1.5
|
| gp70-TT31P.2F10.2792 IgG3 strain, at Year 14 |
1.1
|
| gp70-TV1.21 IgG3 strain, at Day 0 |
1.6
|
| gp70-TV1.21 IgG3 strain, at Day 182 |
11.4
|
| gp70-TV1.21 IgG3 strain, at Day 672 |
1.9
|
| gp70-TV1.21 IgG3 strain, at Year 14 |
2.9
|
| gp70_B.CaseA IgG3 strain, at Day 0 |
1.2
|
| gp70_B.CaseA IgG3 strain, at Day 182 |
58.2
|
| gp70_B.CaseA IgG3 strain, at Day 672 |
2.8
|
| gp70_B.CaseA IgG3 strain, at Year 14 |
1.7
|
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 0 |
1.2
|
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 182 |
89.4
|
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 672 |
7.4
|
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Year 14 |
2.4
|
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 0 |
1.1
|
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 182 |
1.4
|
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 672 |
1.4
|
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Year 14 |
1.3
|
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 0 |
1.8
|
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 182 |
5.0
|
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 672 |
1.3
|
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Year 14 |
2.1
|
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 0 |
1.2
|
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 182 |
1.3
|
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 672 |
1.3
|
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Year 14 |
1.0
|
| Title | Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call |
|---|---|
| Description | 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. |
| Time Frame | At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 29 |
| 254008_D11gp120.avi/293FIgGQual strain, at Day 182 |
29
80.6%
|
| 254008_D11gp120.avi/293FIgGQual strain, at Day 672 |
29
80.6%
|
| 254008_D11gp120.avi/293FIgGQual strain, at Year 14 |
27
75%
|
| 51802_D11gp120.avi/293F IgGQual strain, at Day 182 |
25
69.4%
|
| 51802_D11gp120.avi/293F IgGQual strain, at Day 672 |
18
50%
|
| 51802_D11gp120.avi/293F IgGQual strain, at Year 14 |
6
16.7%
|
| A244 D11gp120_avi IgG Qual strain, at Day 182 |
25
69.4%
|
| A244 D11gp120_avi IgG Qual strain, at Day 672 |
20
55.6%
|
| A244 D11gp120_avi IgG Qual strain, at Year 14 |
8
22.2%
|
| B.6240_D11gp120/293F IgG Qual strain, at Day 182 |
27
75%
|
| B.6240_D11gp120/293F IgG Qual strain, at Day 672 |
23
63.9%
|
| B.6240_D11gp120/293F IgG Qual strain, at Year 14 |
17
47.2%
|
| BJOX002_D11gp120.avi/293FIgGQual strain,at Day 182 |
21
58.3%
|
| BJOX002_D11gp120.avi/293FIgGQual strain,at Day 672 |
13
36.1%
|
| BJOX002_D11gp120.avi/293FIgGQual strain,at Year 14 |
2
5.6%
|
| BORI_D11gp120.avi/293F IgG Qual strain, at Day 182 |
26
72.2%
|
| BORI_D11gp120.avi/293F IgG Qual strain, at Day 672 |
20
55.6%
|
| BORI_D11gp120.avi/293F IgG Qual strain, at Year 14 |
10
27.8%
|
| CNE20_D11gp120.avi/293F IgGQual strain, at Day 182 |
26
72.2%
|
| CNE20_D11gp120.avi/293F IgGQual strain, at Day 672 |
23
63.9%
|
| CNE20_D11gp120.avi/293F IgGQual strain, at Year 14 |
16
44.4%
|
| TT31P.2792_D11gp120.avi/293FIgGQual, at Day 182 |
27
75%
|
| TT31P.2792_D11gp120.avi/293FIgGQual, at Day 672 |
26
72.2%
|
| TT31P.2792_D11gp120.avi/293FIgGQual, at Year 14 |
20
55.6%
|
| 1086C_D7gp120.avi/293F IgG strain, at Day 182 |
27
75%
|
| 1086C_D7gp120.avi/293F IgG strain, at Day 672 |
27
75%
|
| 1086C_D7gp120.avi/293F IgG strain, at Year 14 |
22
61.1%
|
| Con 6 gp120/B IgG strain, at Day 182 |
27
75%
|
| Con 6 gp120/B IgG strain, at Day 672 |
25
69.4%
|
| Con 6 gp120/B IgG strain, at Year 14 |
16
44.4%
|
| gp120 (Clone W6.1D) IgG strain, at Day 182 |
27
75%
|
| gp120 (Clone W6.1D) IgG strain, at Day 672 |
25
69.4%
|
| gp120 (Clone W6.1D) IgG strain, at Year 14 |
19
52.8%
|
| Title | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude |
|---|---|
| Description | 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. |
| Time Frame | At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 34 |
| 254008_D11gp120.avi/293F IgG -BKG strain, at Day 0 |
2.5
|
| 254008_D11gp120.avi/293FIgGQual strain, at Day 182 |
6796.7
|
| 254008_D11gp120.avi/293FIgGQual strain, at day 672 |
1633.3
|
| 254008_D11gp120.avi/293FIgGQual strain, at Year 14 |
479.6
|
| 51802_D11gp120.avi/293F IgG -BKG strain, at Day 0 |
1.0
|
| 51802_D11gp120.avi/293F IgGQual strain, at Day 182 |
993.7
|
| 51802_D11gp120.avi/293F IgGQual strain, at Day 672 |
74.8
|
| 51802_D11gp120.avi/293F IgGQual strain, at Year 14 |
14.4
|
| A244 D11gp120_avi IgG -BKG strain, at Day 0 |
1.4
|
| A244 D11gp120_avi IgG Qual strain, at Day 182 |
990.2
|
| A244 D11gp120_avi IgG Qual strain, at Day 672 |
124.4
|
| A244 D11gp120_avi IgG Qual strain, at Year 14 |
39.8
|
| B.6240_D11gp120/293F IgG -BKG strain, at Day 0 |
1.0
|
| B.6240_D11gp120/293F IgG Qual strain, at Day 182 |
8760.5
|
| B.6240_D11gp120/293F IgG Qual strain, at Day 672 |
634.2
|
| B.6240_D11gp120/293F IgG Qual strain, at Year 14 |
132.8
|
| BJOX002_D11gp120.avi/293F IgG-BKG strain, at Day 0 |
1.1
|
| BJOX002_D11gp120.avi/293FIgGQual strain,at Day 182 |
250.6
|
| BJOX002_D11gp120.avi/293FIgGQual strain,at Day 672 |
31.2
|
| BJOX002_D11gp120.avi/293FIgGQual strain,at Year 14 |
9.9
|
| BORI_D11gp120.avi/293F IgG -BKG strain, at Day 0 |
1.0
|
| BORI_D11gp120.avi/293F IgG Qual strain, at Day 182 |
2811.9
|
| BORI_D11gp120.avi/293F IgG Qual strain, at Day 672 |
148.9
|
| BORI_D11gp120.avi/293F IgG Qual strain, at Year 14 |
35.5
|
| CNE20_D11gp120.avi/293F IgG -BKG strain, at Day 0 |
1.1
|
| CNE20_D11gp120.avi/293F IgGQual strain, at Day 182 |
2925.8
|
| CNE20_D11gp120.avi/293F IgGQual strain, at Day 672 |
587.3
|
| CNE20_D11gp120.avi/293F IgGQual strain, at Year 14 |
126.0
|
| TT31P.2792_D11gp120.avi/293FIgGBKG strain,at Day 0 |
1.6
|
| TT31P.2792_D11gp120.avi/293FIgGQual, at Day 182 |
20622.9
|
| TT31P.2792_D11gp120.avi/293FIgGQual, at Day 672 |
3372.5
|
| TT31P.2792_D11gp120.avi/293FIgGQual, at Year 14 |
568.6
|
| 1086C_D7gp120.avi/293F IgG strain, at Day 0 |
1.1
|
| 1086C_D7gp120.avi/293F IgG strain, at Day 182 |
27145.5
|
| 1086C_D7gp120.avi/293F IgG strain, at Day 672 |
17448.6
|
| 1086C_D7gp120.avi/293F IgG strain, at Year 14 |
4253.8
|
| Con 6 gp120/B IgG strain, at Day 0 |
1.8
|
| Con 6 gp120/B IgG strain, at Day 182 |
10618.0
|
| Con 6 gp120/B IgG strain, at Day 672 |
879.2
|
| Con 6 gp120/B IgG strain, at Year 14 |
176.8
|
| gp120 (Clone W6.1D) IgG strain, at Day 0 |
1.1
|
| gp120 (Clone W6.1D) IgG strain, at Day 182 |
25617.4
|
| gp120 (Clone W6.1D) IgG strain, at Day 672 |
3027.1
|
| gp120 (Clone W6.1D) IgG strain, at Year 14 |
544.6
|
| Title | Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel |
|---|---|
| Description | 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. |
| Time Frame | At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 29 |
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 182 |
28
77.8%
|
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 672 |
27
75%
|
| 1086C_D7gp120.avi/293F IgG1 strain, at Year 14 |
23
63.9%
|
| Con 6 gp120/B IgG1 strain, at Day 182 |
28
77.8%
|
| Con 6 gp120/B IgG1 strain, at Day 672 |
22
61.1%
|
| Con 6 gp120/B IgG1 strain, at Year 14 |
11
30.6%
|
| gp120 (Clone W6.1D) IgG1 strain, at Day 182 |
28
77.8%
|
| gp120 (Clone W6.1D) IgG1 strain, at Day 672 |
25
69.4%
|
| gp120 (Clone W6.1D) IgG1 strain, at Year 14 |
16
44.4%
|
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 182 |
0
0%
|
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 672 |
0
0%
|
| 1086C_D7gp120.avi/293F IgG2 strain, at Year 14 |
0
0%
|
| Con 6 gp120/B IgG2 strain, at Day 182 |
0
0%
|
| Con 6 gp120/B IgG2 strain, at Day 672 |
0
0%
|
| Con 6 gp120/B IgG2 strain, at Year 14 |
0
0%
|
| gp120 (Clone W6.1D) IgG2 strain, at Day 182 |
0
0%
|
| gp120 (Clone W6.1D) IgG2 strain, at Day 672 |
0
0%
|
| gp120 (Clone W6.1D) IgG2 strain, at Year 14 |
0
0%
|
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 182 |
25
69.4%
|
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 672 |
21
58.3%
|
| 1086C_D7gp120.avi/293F IgG3 strain, at Year 14 |
9
25%
|
| Con 6 gp120/B IgG3 strain, at Day 182 |
9
25%
|
| Con 6 gp120/B IgG3 strain, at Day 672 |
0
0%
|
| Con 6 gp120/B IgG3 strain, at Year 14 |
0
0%
|
| gp120 (Clone W6.1D) IgG3 strain, at Day 182 |
19
52.8%
|
| gp120 (Clone W6.1D) IgG3 strain, at Day 672 |
3
8.3%
|
| gp120 (Clone W6.1D) IgG3 strain, at Year 14 |
1
2.8%
|
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 182 |
6
16.7%
|
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 672 |
5
13.9%
|
| 1086C_D7gp120.avi/293F IgG4 strain, at Year 14 |
7
19.4%
|
| Con 6 gp120/B IgG4 strain, at Day 182 |
1
2.8%
|
| Con 6 gp120/B IgG4 strain, at Day 672 |
2
5.6%
|
| Con 6 gp120/B IgG4 strain, at Year 14 |
2
5.6%
|
| gp120 (Clone W6.1D) IgG4 strain, at Day 182 |
8
22.2%
|
| gp120 (Clone W6.1D) IgG4 strain, at Day 672 |
3
8.3%
|
| gp120 (Clone W6.1D) IgG4 strain, at Year 14 |
3
8.3%
|
| Title | Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel |
|---|---|
| Description | 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. |
| Time Frame | At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 34 |
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 0 |
1.0
|
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 182 |
10365.4
|
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 672 |
2834.1
|
| 1086C_D7gp120.avi/293F IgG1 strain, at Year 14 |
371.0
|
| Con 6 gp120/B IgG1 strain, at Day 0 |
1.0
|
| Con 6 gp120/B IgG1 strain, at Day 182 |
4396.8
|
| Con 6 gp120/B IgG1 strain, at Day 672 |
246.0
|
| Con 6 gp120/B IgG1 strain, at Year 14 |
21.5
|
| gp120 (Clone W6.1D) IgG1 strain, at Day 0 |
1.0
|
| gp120 (Clone W6.1D) IgG1 strain, at Day 182 |
11572.9
|
| gp120 (Clone W6.1D) IgG1 strain, at Day 672 |
653.3
|
| gp120 (Clone W6.1D) IgG1 strain, at Year 14 |
47.0
|
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 0 |
1.2
|
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 182 |
2.6
|
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 672 |
2.4
|
| 1086C_D7gp120.avi/293F IgG2 strain, at Year 14 |
1.1
|
| Con 6 gp120/B IgG2 strain, at Day 0 |
1.1
|
| Con 6 gp120/B IgG2 strain, at Day 182 |
1.3
|
| Con 6 gp120/B IgG2 strain, at Day 672 |
1.4
|
| Con 6 gp120/B IgG2 strain, at Year 14 |
1.3
|
| gp120 (Clone W6.1D) IgG2 strain, at Day 0 |
1.0
|
| gp120 (Clone W6.1D) IgG2 strain, at Day 182 |
1.9
|
| gp120 (Clone W6.1D) IgG2 strain, at Day 672 |
1.5
|
| gp120 (Clone W6.1D) IgG2 strain, at Year 14 |
1.1
|
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 0 |
1.5
|
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 182 |
417.1
|
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 672 |
206.3
|
| 1086C_D7gp120.avi/293F IgG3 strain, at Year 14 |
42.8
|
| Con 6 gp120/B IgG3 strain, at Day 0 |
1.1
|
| Con 6 gp120/B IgG3 strain, at Day 182 |
60.8
|
| Con 6 gp120/B IgG3 strain, at Day 672 |
11.0
|
| Con 6 gp120/B IgG3 strain, at Year 14 |
2.9
|
| gp120 (Clone W6.1D) IgG3 strain, at Day 0 |
1.1
|
| gp120 (Clone W6.1D) IgG3 strain, at Day 182 |
161.9
|
| gp120 (Clone W6.1D) IgG3 strain, at Day 672 |
24.3
|
| gp120 (Clone W6.1D) IgG3 strain, at Year 14 |
7.8
|
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 0 |
1.2
|
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 182 |
47.0
|
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 672 |
30.1
|
| 1086C_D7gp120.avi/293F IgG4 strain, at Year 14 |
20.3
|
| Con 6 gp120/B IgG4 strain, at Day 0 |
1.0
|
| Con 6 gp120/B IgG4 strain, at Day 182 |
14.9
|
| Con 6 gp120/B IgG4 strain, at Day 672 |
6.6
|
| Con 6 gp120/B IgG4 strain, at Year 14 |
4.7
|
| gp120 (Clone W6.1D) IgG4 strain, at Day 0 |
1.1
|
| gp120 (Clone W6.1D) IgG4 strain, at Day 182 |
52.8
|
| gp120 (Clone W6.1D) IgG4 strain, at Day 672 |
21.3
|
| gp120 (Clone W6.1D) IgG4 strain, at Year 14 |
10.4
|
| Title | Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers |
|---|---|
| Description | 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. |
| Time Frame | At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 33 |
| At Day 0 |
0.00
|
| At Day 98 |
0.42
|
| At Day 672 |
0.32
|
| At Year 14 |
0.21
|
| Title | Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers |
|---|---|
| Description | 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. |
| Time Frame | At Day 98 and at Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 26 |
| At Day 98 |
25
69.4%
|
| At Day 672 |
23
63.9%
|
| At Year 14 |
22
61.1%
|
| Title | Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers |
|---|---|
| Description | 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. |
| Time Frame | At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 33 |
| At Day 0 |
0.00
|
| At Day 98 |
0.00
|
| At Day 672 |
0.00
|
| At Year 14 |
0.00
|
| Title | Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers |
|---|---|
| Description | 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. |
| Time Frame | At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSKSB732461 Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 33 |
| At Day 98 |
0
0%
|
| At Day 672 |
0
0%
|
| At Year 14 |
0
0%
|
Adverse Events
| Time Frame | Serious adverse events were reported during the whole study period (single study visit, at Year 14). Adverse events were not collected. | |
|---|---|---|
| Adverse Event Reporting Description | Only SAEs related to study participation or to a concurrent GSK medication/product were collected and recorded from the time the subject consented to participate in the study (i.e., ICF signature) until the subject was discharged from the study. | |
| Arm/Group Title | GSKSB732461 Group | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| GSKSB732461 Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/36 (0%) | |
Serious Adverse Events |
||
| GSKSB732461 Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/36 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| GSKSB732461 Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 877-379-3718 |
| GSKClinicalSupportHD@gsk.com |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT03368053
Other Study ID Numbers:
- 201606
First Posted:
Dec 11, 2017
Last Update Posted:
Oct 20, 2020
Last Verified:
Sep 1, 2020