HIV Infections, Infection, Human Immunodeficiency Virus
Conditions
Keywords
gp120, HIV infections, RV144, gp120-NefTat/AS01B vaccine candidate, V1V2
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.
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.
Interventions
PROCEDUREBlood 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.
Sponsors
University Ghent
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Descriptive mono-centric study with one single group.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Belgium
Participant flow
Recruitment details
This study was conducted at one Centre in Belgium.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | GSKSB732461 Group |
|---|---|
| Age, Continuous | 43.5 Years STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 1 Participants |
| Race/Ethnicity, Customized WHITE - CAUCASIAN / EUROPEAN HERITAGE | 35 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-700010058 IgG3 strain, at Day 672 | 1.3 MFI |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-001428.2.42 IgG3 strain, at Day 0 | 1.7 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-001428.2.42 IgG3 strain, at Day 182 | 2.6 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-001428.2.42 IgG3 strain, at Day 672 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-001428.2.42 IgG3 strain, at Year 14 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-191084_B7 IgG3 strain, at Day 0 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-191084_B7 IgG3 strain, at Day 182 | 4.6 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-191084_B7 IgG3 strain, at Day 672 | 1.6 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-191084_B7 IgG3 strain, at Year 14 | 2.8 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-62357.14 IgG3 strain, at Day 0 | 2.1 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-62357.14 IgG3 strain, at Day 182 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-62357.14 IgG3 strain, at Day 672 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-62357.14 IgG3 strain, at Year 14 | 4.1 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-700010058 IgG3 strain, at Day 0 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-700010058 IgG3 strain, at Day 182 | 11.9 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-700010058 IgG3 strain, at Year 14 | 2.9 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-7060101641 IgG3 strain, at Day 0 | 1.1 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-7060101641 IgG3 strain, at Day 182 | 3.7 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-7060101641 IgG3 strain, at Day 672 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-7060101641 IgG3 strain, at Year 14 | 1.0 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-96ZM651.02 IgG3 strain, at Day 0 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-96ZM651.02 IgG3 strain, at Day 182 | 1.8 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-96ZM651.02 IgG3 strain, at Day 672 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-96ZM651.02 IgG3 strain, at Year 14 | 1.6 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-BF1266_431a IgG3 strain, at Day 0 | 1.0 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-BF1266_431a IgG3 strain, at Day 182 | 13.2 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-BF1266_431a IgG3 strain, at Day 672 | 1.8 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-BF1266_431a IgG3 strain, at Year 14 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-BJOX002000.03.2 IgG3 strain, at Day 0 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-BJOX002000.03.2 IgG3 strain, at Day 182 | 4.7 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-BJOX002000.03.2 IgG3 strain, at Day 672 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-BJOX002000.03.2 IgG3 strain, at Year 14 | 1.6 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-C2101.c01 IgG3 strain, at Day 0 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-C2101.c01 IgG3 strain, at Day 182 | 4.7 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-C2101.c01 IgG3 strain, at Day 672 | 1.7 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-C2101.c01 IgG3 strain, at Year 14 | 1.9 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-CAP210.2.00.E8 IgG3 strain, at Day 0 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-CAP210.2.00.E8 IgG3 strain, at Day 182 | 5.9 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-CAP210.2.00.E8 IgG3 strain, at Day 672 | 1.6 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-CAP210.2.00.E8 IgG3 strain, at Year 14 | 2.1 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-CM244.ec1 IgG3 strain, at Day 0 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-CM244.ec1 IgG3 strain, at Day 182 | 4.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-CM244.ec1 IgG3 strain, at Day 672 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-CM244.ec1 IgG3 strain, at Year 14 | 4.0 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-Ce1086_B2 IgG3 strain, at Day 0 | 1.7 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-Ce1086_B2 IgG3 strain, at Day 182 | 3.0 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-Ce1086_B2 IgG3 strain, at Day 672 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-Ce1086_B2 IgG3 strain, at Year 14 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-RHPA4259.7 IgG3 strain, at Day 0 | 1.1 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-RHPA4259.7 IgG3 strain, at Day 182 | 4.0 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-RHPA4259.7 IgG3 strain, at Day 672 | 1.0 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-RHPA4259.7 IgG3 strain, at Year 14 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-TT31P.2F10.2792 IgG3 strain, at Day 0 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-TT31P.2F10.2792 IgG3 strain, at Day 182 | 9.9 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-TT31P.2F10.2792 IgG3 strain, at Day 672 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-TT31P.2F10.2792 IgG3 strain, at Year 14 | 1.1 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-TV1.21 IgG3 strain, at Day 0 | 1.6 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-TV1.21 IgG3 strain, at Day 182 | 11.4 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-TV1.21 IgG3 strain, at Day 672 | 1.9 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70-TV1.21 IgG3 strain, at Year 14 | 2.9 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70_B.CaseA IgG3 strain, at Day 0 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70_B.CaseA IgG3 strain, at Day 182 | 58.2 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70_B.CaseA IgG3 strain, at Day 672 | 2.8 MFI |
| GSKSB732461 Group | Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude | gp70_B.CaseA IgG3 strain, at Year 14 | 1.7 MFI |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
Primary
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-62357.14 strain, at Day 182 | 33.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-62357.14 strain, at Day 672 | 2.0 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-62357.14 strain, at Year 14 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-700010058 strain, at Day 0 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-BF1266_431a strain, at Day 672 | 414.6 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-001428.2.42 strain, at Day 0 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-001428.2.42 strain, at Day 182 | 5444.9 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-001428.2.42 strain, at Day 672 | 147.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-001428.2.42 strain, at Year 14 | 29.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-191084_B7 strain, at Day 0 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-191084_B7 strain, at Day 182 | 1272.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-191084_B7 strain, at Day 672 | 98.2 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-191084_B7 strain, at Year 14 | 28.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-62357.14 strain, at Day 0 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-7060101641 strain, at Day 0 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-700010058 strain, at Day 182 | 18048.6 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-700010058 strain, at Day 672 | 925.0 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-700010058 strain, at Year 14 | 130.1 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-7060101641 strain, at Day 182 | 353.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-7060101641 strain, at Day 672 | 23.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-7060101641 strain, at Year 14 | 13.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-96ZM651.02 strain, at Day 0 | 1.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-96ZM651.02 strain, at Day 182 | 777.3 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-96ZM651.02 strain, at Day 672 | 11.2 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-96ZM651.02 strain, at Year 14 | 4.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-BF1266_431a strain, at Day 0 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-BF1266_431a strain, at Day 182 | 7838.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-BF1266_431a strain, at Year 14 | 94.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-BJOX002000.03.2 strain, at Day 0 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-BJOX002000.03.2 strain, at Day 182 | 4033.1 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-BJOX002000.03.2 strain, at Day 672 | 113.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-BJOX002000.03.2 strain, at Year 14 | 22.3 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-C2101.c01 strain, at Day 0 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-C2101.c01 strain, at Day 182 | 1454.2 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-C2101.c01 strain, at Day 672 | 85.0 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-C2101.c01 strain, at Year 14 | 28.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-CAP210.2.00.E8 strain, at Day 0 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-CAP210.2.00.E8 strain, at Day 182 | 5862.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-CAP210.2.00.E8 strain, at Day 672 | 150.2 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-CAP210.2.00.E8 strain, at Year 14 | 32.9 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-CM244.ec1 strain, at Day 0 | 1.6 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-CM244.ec1 strain, at Day 182 | 2770.8 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-CM244.ec1 strain, at Day 672 | 98.6 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-CM244.ec strain, at Year 14 | 33.0 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-Ce1086_B2 strain, at Day 0 | 1.3 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-Ce1086_B2 strain, at Day 182 | 2336.9 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-Ce1086_B2 strain, at Day 672 | 82.8 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-Ce1086_B2 strain, at Year 14 | 23.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-RHPA4259.7 strain, at Day 0 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-RHPA4259.7 strain, at Day 182 | 2033.8 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-RHPA4259.7 strain, at Day 672 | 30.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-RHPA4259.7 strain, at Year 14 | 6.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-TT31P.2F10.2792 strain, at Day 0 | 1.5 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-TT31P.2F10.2792 strain, at Day 182 | 10998.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-TT31P.2F10.2792 strain, at Day 672 | 312.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-TT31P.2F10.2792 strain, at Year 14 | 71.9 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-TV1.21 strain, at Day 0 | 1.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-TV1.21 strain, at Day 182 | 10684.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-TV1.21 strain, at Day 672 | 382.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70-TV1.21 strain, at Year 14 | 75.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70_B.CaseA strain, at Day 0 | 1.7 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70_B.CaseA strain, at Day 182 | 21647.6 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70_B.CaseA strain, at Day 672 | 1104.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | gp70_B.CaseA strain, at Year 14 | 166.6 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | C.1086C_V1_V2 Tags strain, at Day 0 | 1.2 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | C.1086C_V1_V2 Tags strain, at Day 182 | 216.4 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | C.1086C_V1_V2 Tags strain, at Day 672 | 15.1 MFI |
| GSKSB732461 Group | Anti-V1V2 Total IgG Antibody BAMA Response Magnitude | C.1086C_V1_V2 Tags strain, at Year 14 | 4.7 MFI |
Primary
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call | gp70-700010058 IgG3 strain, at Day 182 | 3 Participants |
| GSKSB732461 Group | Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call | gp70-700010058 IgG3 strain, at Day 672 | 0 Participants |
| GSKSB732461 Group | Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call | gp70-700010058 IgG3 strain, at Year 14 | 0 Participants |
| GSKSB732461 Group | Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call | gp70-7060101641 IgG3 strain, at Day 182 | 0 Participants |
| GSKSB732461 Group | Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call | gp70-7060101641 IgG3 strain, at Day 672 | 0 Participants |
| GSKSB732461 Group | Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call | gp70-7060101641 IgG3 strain, at Year 14 | 0 Participants |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
Secondary
Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
Secondary
Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 254008_D11gp120.avi/293FIgGQual strain, at Day 182 | 6796.7 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | BORI_D11gp120.avi/293F IgG Qual strain, at Year 14 | 35.5 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 254008_D11gp120.avi/293F IgG -BKG strain, at Day 0 | 2.5 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 254008_D11gp120.avi/293FIgGQual strain, at day 672 | 1633.3 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 254008_D11gp120.avi/293FIgGQual strain, at Year 14 | 479.6 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 51802_D11gp120.avi/293F IgG -BKG strain, at Day 0 | 1.0 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 51802_D11gp120.avi/293F IgGQual strain, at Day 182 | 993.7 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 51802_D11gp120.avi/293F IgGQual strain, at Day 672 | 74.8 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 51802_D11gp120.avi/293F IgGQual strain, at Year 14 | 14.4 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | A244 D11gp120_avi IgG -BKG strain, at Day 0 | 1.4 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | A244 D11gp120_avi IgG Qual strain, at Day 182 | 990.2 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | A244 D11gp120_avi IgG Qual strain, at Day 672 | 124.4 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | A244 D11gp120_avi IgG Qual strain, at Year 14 | 39.8 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | B.6240_D11gp120/293F IgG -BKG strain, at Day 0 | 1.0 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | B.6240_D11gp120/293F IgG Qual strain, at Day 182 | 8760.5 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | B.6240_D11gp120/293F IgG Qual strain, at Day 672 | 634.2 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | B.6240_D11gp120/293F IgG Qual strain, at Year 14 | 132.8 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | BJOX002_D11gp120.avi/293F IgG-BKG strain, at Day 0 | 1.1 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | BJOX002_D11gp120.avi/293FIgGQual strain,at Day 182 | 250.6 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | BJOX002_D11gp120.avi/293FIgGQual strain,at Day 672 | 31.2 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | BJOX002_D11gp120.avi/293FIgGQual strain,at Year 14 | 9.9 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | BORI_D11gp120.avi/293F IgG -BKG strain, at Day 0 | 1.0 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | BORI_D11gp120.avi/293F IgG Qual strain, at Day 182 | 2811.9 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | BORI_D11gp120.avi/293F IgG Qual strain, at Day 672 | 148.9 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | CNE20_D11gp120.avi/293F IgG -BKG strain, at Day 0 | 1.1 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | CNE20_D11gp120.avi/293F IgGQual strain, at Day 182 | 2925.8 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | CNE20_D11gp120.avi/293F IgGQual strain, at Day 672 | 587.3 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | CNE20_D11gp120.avi/293F IgGQual strain, at Year 14 | 126.0 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | TT31P.2792_D11gp120.avi/293FIgGBKG strain,at Day 0 | 1.6 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | TT31P.2792_D11gp120.avi/293FIgGQual, at Day 182 | 20622.9 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | TT31P.2792_D11gp120.avi/293FIgGQual, at Day 672 | 3372.5 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | TT31P.2792_D11gp120.avi/293FIgGQual, at Year 14 | 568.6 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 1086C_D7gp120.avi/293F IgG strain, at Day 0 | 1.1 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 1086C_D7gp120.avi/293F IgG strain, at Day 182 | 27145.5 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 1086C_D7gp120.avi/293F IgG strain, at Day 672 | 17448.6 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | 1086C_D7gp120.avi/293F IgG strain, at Year 14 | 4253.8 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | Con 6 gp120/B IgG strain, at Day 0 | 1.8 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | Con 6 gp120/B IgG strain, at Day 182 | 10618.0 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | Con 6 gp120/B IgG strain, at Day 672 | 879.2 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | Con 6 gp120/B IgG strain, at Year 14 | 176.8 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | gp120 (Clone W6.1D) IgG strain, at Day 0 | 1.1 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | gp120 (Clone W6.1D) IgG strain, at Day 182 | 25617.4 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | gp120 (Clone W6.1D) IgG strain, at Day 672 | 3027.1 MFI |
| GSKSB732461 Group | Anti-gp 120 Total IgG Antibody BAMA Response Magnitude | gp120 (Clone W6.1D) IgG strain, at Year 14 | 544.6 MFI |
Secondary
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
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
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
Secondary
Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers
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
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
Secondary
Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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
Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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 |
| GSKSB732461 Group | 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
Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSKSB732461 Group | Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers | At Day 672 | 23 Participants |
| GSKSB732461 Group | Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers | At Day 98 | 25 Participants |
| GSKSB732461 Group | Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers | At Year 14 | 22 Participants |
Secondary
Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSKSB732461 Group | Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers | At Day 98 | 0 Participants |
| GSKSB732461 Group | Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers | At Day 672 | 0 Participants |
| GSKSB732461 Group | Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers | At Year 14 | 0 Participants |