A Phase 1 interventional study of Blood sampling in Infection, Human Immunodeficiency Virus and HIV Infections, sponsored by GlaxoSmithKline. Completed at 1 site in Belgium. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Basic science
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Among 265 studies in HIV Infections by GlaxoSmithKline — 14 open to participants now, 26 under way, 8 of them phase 3. HIV Infections · GlaxoSmithKline.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 151st largest by enrollment of the 209 interventional ones that give a count, is one of 10 that started in 2017, is one of 82 in phase 1, and was the 184th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →14 of the 265 studies in HIV Infections by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in Romania, South Africa, Uganda
ViiV Healthcare · Sites in Netherlands
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in South Africa
Ages up to 10 days · Healthy volunteers
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 30 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 53 · Phase 3 68 · Phase 4 18
First in 1994; this study’s year is marked. 10 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 84 across the 209 interventional studies, 328 across the 14 observational. Of the 230 that completed or were terminated, 95 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
5 of the studies in HIV Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07053384ViiV HealthcareA Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV | 2027-01-22 |
| NCT07934719ViiV HealthcareMass Balance and Absolute Bioavailability of [14C]-VH4011499 | 2027-02-18 |
| NCT06786520ViiV HealthcareA Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults | 2027-03-08 |
| NCT07525544ViiV HealthcareA Study to Investigate the Safety and PK of VH4770359 in Healthy Participants | 2027-05-05 |
| NCT07202546ViiV HealthcareA Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) | 2027-10-28 |
Add all 5 to your calendar (.ics) → With an account.
Among the 265 studies in HIV Infections by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Compared within HIV Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
Procedure: Blood sampling
Blood samples will be taken during the single study visit at Year 14 for the assessment of: HIV testing, antibody determination, cell mediated immune (CMI) responses and exploratory characterisation.
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
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
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
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
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
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
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
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
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
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
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
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
This study was conducted at one Centre in Belgium.
| Milestone | GSKSB732461 Group |
|---|---|
| Started | 36 |
| Completed | 36 |
| Not completed | 0 |
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.
| Participants | GSKSB732461 Group |
|---|---|
| gp70-001428.2.42 strain, at Day 182 | 25 |
| gp70-001428.2.42 strain, at Day 672 | 15 |
| gp70-001428.2.42 strain, at Year 14 | 8 |
| gp70-191084_B7 strain, at Day 182 | 20 |
| gp70-191084_B7 strain, at Day 672 | 12 |
| gp70-191084_B7 strain, at Year 14 | 9 |
| gp70-62357.14 strain, at Day 182 | 12 |
| gp70-62357.14 strain, at Day 672 | 1 |
| gp70-62357.14 strain, at Year 14 | 0 |
| gp70-700010058 strain, at Day 182 | 26 |
| gp70-700010058 strain, at Day 672 | 19 |
| gp70-700010058 strain, at Year 14 | 13 |
| gp70-7060101641 strain, at Day 182 | 18 |
| gp70-7060101641 strain, at Day 672 | 9 |
| gp70-7060101641 strain, at Year 14 | 4 |
| gp70-96ZM651.02 strain, at Day 182 | 21 |
| gp70-96ZM651.02 strain, at Day 672 | 4 |
| gp70-96ZM651.02 strain, at Year 14 | 2 |
| gp70-BF1266_431a strain, at Day 182 | 24 |
| gp70-BF1266_431a strain, at Day 672 | 16 |
| gp70-BF1266_431a strain, at Year 14 | 11 |
| gp70-BJOX002000.03.2 strain, at Day 182 | 24 |
| gp70-BJOX002000.03.2 strain, at Day 672 | 14 |
| gp70-BJOX002000.03.2 strain, at Year 14 | 6 |
| gp70-C2101.c01 strain, at Day 182 | 20 |
| gp70-C2101.c01 strain, at Day 672 | 12 |
| gp70-C2101.c01 strain, at Year 14 | 8 |
| gp70-CAP210.2.00.E8 strain, at Day 182 | 26 |
| gp70-CAP210.2.00.E8 strain, at Day 672 | 15 |
| gp70-CAP210.2.00.E8 strain, at Year 14 | 7 |
| gp70-CM244.ec1 strain, Day 182 | 22 |
| gp70-CM244.ec1 strain, at Day 672 | 13 |
| gp70-CM244.ec1 strain, at Year 14 | 7 |
| gp70-Ce1086_B2 strain, at Day 182 | 23 |
| gp70-Ce1086_B2 strain, at Day 672 | 14 |
| gp70-Ce1086_B2 strain, at Year 14 | 6 |
| gp70-RHPA4259.7 strain, at Day 182 | 22 |
| gp70-RHPA4259.7 strain, at Day 672 | 9 |
| gp70-RHPA4259.7 strain, at Year 14 | 2 |
| gp70-TT31P.2F10.2792 strain, at Day 182 | 26 |
| gp70-TT31P.2F10.2792 strain, at Day 672 | 18 |
| gp70-TT31P.2F10.2792 strain, at Year 14 | 10 |
| gp70-TV1.21 strain, at Day 182 | 26 |
| gp70-TV1.21 strain, at Day 672 | 18 |
| gp70-TV1.21 strain, at Year 14 | 9 |
| gp70_B.CaseA strain, at Day 182 | 26 |
| gp70_B.CaseA strain, at Day 672 | 21 |
| gp70_B.CaseA strain, at Year 14 | 12 |
| C.1086C_V1_V2 Tags strain, at Day 182 | 19 |
| C.1086C_V1_V2 Tags strain, at Day 672 | 5 |
| C.1086C_V1_V2 Tags strain, at Year 14 | 3 |
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.
| MFI | GSKSB732461 Group |
|---|---|
| gp70-001428.2.42 strain, at Day 0 | 1.3 (0.9 to 1.9) |
| gp70-001428.2.42 strain, at Day 182 | 5444.9 (2974.9 to 9965.9) |
| gp70-001428.2.42 strain, at Day 672 | 147.5 (41.1 to 529.7) |
| gp70-001428.2.42 strain, at Year 14 | 29.5 (9.4 to 92.9) |
| gp70-191084_B7 strain, at Day 0 | 1.4 (0.9 to 2.1) |
| gp70-191084_B7 strain, at Day 182 | 1272.5 (308.2 to 5254.8) |
| gp70-191084_B7 strain, at Day 672 | 98.2 (22.6 to 426.5) |
| gp70-191084_B7 strain, at Year 14 | 28.4 (6.6 to 122.9) |
| gp70-62357.14 strain, at Day 0 | 1.4 (0.8 to 2.4) |
| gp70-62357.14 strain, at Day 182 | 33.4 (11.3 to 98.5) |
| gp70-62357.14 strain, at Day 672 | 2.0 (1.0 to 3.8) |
| gp70-62357.14 strain, at Year 14 | 1.2 (0.9 to 1.7) |
| gp70-700010058 strain, at Day 0 | 1.4 (0.9 to 2.1) |
| gp70-700010058 strain, at Day 182 | 18048.6 (12831.6 to 25386.6) |
| gp70-700010058 strain, at Day 672 | 925.0 (264.5 to 3235.1) |
| gp70-700010058 strain, at Year 14 | 130.1 (36.7 to 461.3) |
| gp70-7060101641 strain, at Day 0 | 1.2 (0.9 to 1.7) |
| gp70-7060101641 strain, at Day 182 | 353.7 (108.0 to 1157.8) |
| gp70-7060101641 strain, at Day 672 | 23.5 (6.8 to 81.0) |
| gp70-7060101641 strain, at Year 14 | 13.4 (4.4 to 40.5) |
| gp70-96ZM651.02 strain, at Day 0 | 1.7 (1.0 to 3.0) |
| gp70-96ZM651.02 strain, at Day 182 | 777.3 (286.8 to 2106.5) |
| gp70-96ZM651.02 strain, at Day 672 | 11.2 (3.7 to 33.5) |
| gp70-96ZM651.02 strain, at Year 14 | 4.5 (1.9 to 10.6) |
| gp70-BF1266_431a strain, at Day 0 | 1.3 (0.9 to 2.1) |
| gp70-BF1266_431a strain, at Day 182 | 7838.7 (3122.7 to 19676.7) |
| gp70-BF1266_431a strain, at Day 672 | 414.6 (90.9 to 1890.9) |
| gp70-BF1266_431a strain, at Year 14 | 94.7 (22.0 to 408.3) |
| gp70-BJOX002000.03.2 strain, at Day 0 | 1.3 (0.9 to 1.8) |
| gp70-BJOX002000.03.2 strain, at Day 182 | 4033.1 (1722.3 to 9444.1) |
| gp70-BJOX002000.03.2 strain, at Day 672 | 113.7 (30.5 to 424.5) |
| gp70-BJOX002000.03.2 strain, at Year 14 | 22.3 (6.6 to 75.3) |
| gp70-C2101.c01 strain, at Day 0 | 1.3 (0.9 to 1.6) |
| gp70-C2101.c01 strain, at Day 182 | 1454.2 (356.9 to 5925.2) |
| gp70-C2101.c01 strain, at Day 672 | 85.0 (17.1 to 422.6) |
| gp70-C2101.c01 strain, at Year 14 | 28.7 (6.2 to 131.8) |
| gp70-CAP210.2.00.E8 strain, at Day 0 | 1.2 (0.9 to 1.6) |
| gp70-CAP210.2.00.E8 strain, at Day 182 | 5862.5 (3157.3 to 10885.8) |
| gp70-CAP210.2.00.E8 strain, at Day 672 | 150.2 (40.6 to 556.2) |
| gp70-CAP210.2.00.E8 strain, at Year 14 | 32.9 (9.7 to 111.0) |
| gp70-CM244.ec1 strain, at Day 0 | 1.6 (0.9 to 2.6) |
| gp70-CM244.ec1 strain, at Day 182 | 2770.8 (1057.6 to 7259.5) |
| gp70-CM244.ec1 strain, at Day 672 | 98.6 (22.7 to 429.2) |
| gp70-CM244.ec strain, at Year 14 | 33.0 (8.7 to 124.8) |
| gp70-Ce1086_B2 strain, at Day 0 | 1.3 (0.9 to 2.0) |
| gp70-Ce1086_B2 strain, at Day 182 | 2336.9 (889.9 to 6136.8) |
| gp70-Ce1086_B2 strain, at Day 672 | 82.8 (20.9 to 328.6) |
| gp70-Ce1086_B2 strain, at Year 14 | 23.4 (6.6 to 83.3) |
| gp70-RHPA4259.7 strain, at Day 0 | 1.5 (0.9 to 2.4) |
| gp70-RHPA4259.7 strain, at Day 182 | 2033.8 (638.2 to 6481.8) |
| gp70-RHPA4259.7 strain, at Day 672 | 30.4 (8.9 to 103.9) |
| gp70-RHPA4259.7 strain, at Year 14 | 6.5 (2.5 to 17.1) |
| gp70-TT31P.2F10.2792 strain, at Day 0 | 1.5 (0.9 to 2.4) |
| gp70-TT31P.2F10.2792 strain, at Day 182 | 10998.7 (6967.0 to 17363.3) |
| gp70-TT31P.2F10.2792 strain, at Day 672 | 312.7 (82.8 to 1181.0) |
| gp70-TT31P.2F10.2792 strain, at Year 14 | 71.9 (20.9 to 247.8) |
| gp70-TV1.21 strain, at Day 0 | 1.4 (0.9 to 2.2) |
| gp70-TV1.21 strain, at Day 182 | 10684.4 (6527.9 to 17487.7) |
| gp70-TV1.21 strain, at Day 672 | 382.4 (108.3 to 1350.5) |
| gp70-TV1.21 strain, at Year 14 | 75.7 (21.6 to 265.4) |
| gp70_B.CaseA strain, at Day 0 | 1.7 (0.9 to 3.1) |
| gp70_B.CaseA strain, at Day 182 | 21647.6 (16859.7 to 27795.3) |
| gp70_B.CaseA strain, at Day 672 | 1104.4 (327.0 to 3730.2) |
| gp70_B.CaseA strain, at Year 14 | 166.6 (46.9 to 591.5) |
| C.1086C_V1_V2 Tags strain, at Day 0 | 1.2 (0.8 to 1.9) |
| C.1086C_V1_V2 Tags strain, at Day 182 | 216.4 (76.9 to 609.1) |
| C.1086C_V1_V2 Tags strain, at Day 672 | 15.1 (5.8 to 39.6) |
| C.1086C_V1_V2 Tags strain, at Year 14 | 4.7 (2.0 to 11.5) |
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.
| Participants | GSKSB732461 Group |
|---|---|
| gp70-001428.2.42 IgG3 strain, at Day 182 | 2 |
| gp70-001428.2.42 IgG3 strain, at Day 672 | 0 |
| gp70-001428.2.42 IgG3 strain, at Year 14 | 0 |
| gp70-191084_B7 IgG3 strain, at Day 182 | 2 |
| gp70-191084_B7 IgG3 strain, at Day 672 | 1 |
| gp70-191084_B7 IgG3 strain, at Year 14 | 0 |
| gp70-62357.14 IgG3 strain, at Day 182 | 0 |
| gp70-62357.14 IgG3 strain, at Day 672 | 0 |
| gp70-62357.14 IgG3 strain, at Year 14 | 0 |
| gp70-700010058 IgG3 strain, at Day 182 | 3 |
| gp70-700010058 IgG3 strain, at Day 672 | 0 |
| gp70-700010058 IgG3 strain, at Year 14 | 0 |
| gp70-7060101641 IgG3 strain, at Day 182 | 0 |
| gp70-7060101641 IgG3 strain, at Day 672 | 0 |
| gp70-7060101641 IgG3 strain, at Year 14 | 0 |
| gp70-96ZM651.02 IgG3 strain, at Day 182 | 0 |
| gp70-96ZM651.02 IgG3 strain, at Day 672 | 0 |
| gp70-96ZM651.02 IgG3 strain, at Year 14 | 0 |
| gp70-BF1266_431a IgG3 strain, at Day 182 | 5 |
| gp70-BF1266_431a IgG3 strain, at Day 672 | 2 |
| gp70-BF1266_431a IgG3 strain, at Year 14 | 0 |
| gp70-BJOX002000.03.2 IgG3 strain, at Day 182 | 0 |
| gp70-BJOX002000.03.2 IgG3 strain, at Day 672 | 0 |
| gp70-BJOX002000.03.2 IgG3 strain, at Year 14 | 0 |
| gp70-C2101.c01 IgG3 strain, at Day 182 | 2 |
| gp70-C2101.c01 IgG3 strain, at Day 672 | 1 |
| gp70-C2101.c01 IgG3 strain, at Year 14 | 0 |
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 182 | 0 |
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 672 | 0 |
| gp70-CAP210.2.00.E8 IgG3 strain, at Year 14 | 0 |
| gp70-CM244.ec1 IgG3 strain, at Day 182 | 1 |
| gp70-CM244.ec1 IgG3 strain, at Day 672 | 0 |
| gp70-CM244.ec1 IgG3 strain, at Year 14 | 1 |
| gp70-Ce1086_B2 IgG3 strain, at Day 182 | 0 |
| gp70-Ce1086_B2 IgG3 strain, at Day 672 | 0 |
| gp70-Ce1086_B2 IgG3 strain, at Year 14 | 1 |
| gp70-RHPA4259.7 IgG3 strain, at Day 182 | 3 |
| gp70-RHPA4259.7 IgG3 strain, at Day 672 | 0 |
| gp70-RHPA4259.7 IgG3 strain, at Year 14 | 0 |
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 182 | 2 |
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 672 | 0 |
| gp70-TT31P.2F10.2792 IgG3 strain, at Year 14 | 0 |
| gp70-TV1.21 IgG3 strain, at Day 182 | 3 |
| gp70-TV1.21 IgG3 strain, at Day 672 | 0 |
| gp70-TV1.21 IgG3 strain, at Year 14 | 0 |
| gp70_B.CaseA IgG3 strain, at Day 182 | 11 |
| gp70_B.CaseA IgG3 strain, at Day 672 | 2 |
| gp70_B.CaseA IgG3 strain, at Year 14 | 0 |
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 182 | 15 |
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 672 | 5 |
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Year 14 | 2 |
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 182 | 1 |
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 672 | 1 |
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Year 14 | 1 |
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 182 | 5 |
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 672 | 0 |
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Year 14 | 0 |
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 182 | 0 |
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 672 | 0 |
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Year 14 | 0 |
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.
| MFI | GSKSB732461 Group |
|---|---|
| gp70-001428.2.42 IgG3 strain, at Day 0 | 1.7 (1.1 to 2.6) |
| gp70-001428.2.42 IgG3 strain, at Day 182 | 2.6 (1.5 to 4.4) |
| gp70-001428.2.42 IgG3 strain, at Day 672 | 1.5 (1.1 to 2.1) |
| gp70-001428.2.42 IgG3 strain, at Year 14 | 1.4 (1.0 to 1.9) |
| gp70-191084_B7 IgG3 strain, at Day 0 | 1.5 (1.1 to 2.1) |
| gp70-191084_B7 IgG3 strain, at Day 182 | 4.6 (2.6 to 8.1) |
| gp70-191084_B7 IgG3 strain, at Day 672 | 1.6 (1.1 to 2.6) |
| gp70-191084_B7 IgG3 strain, at Year 14 | 2.8 (1.8 to 4.2) |
| gp70-62357.14 IgG3 strain, at Day 0 | 2.1 (1.4 to 3.2) |
| gp70-62357.14 IgG3 strain, at Day 182 | 1.2 (1.0 to 1.4) |
| gp70-62357.14 IgG3 strain, at Day 672 | 1.3 (1.0 to 1.6) |
| gp70-62357.14 IgG3 strain, at Year 14 | 4.1 (2.8 to 6.0) |
| gp70-700010058 IgG3 strain, at Day 0 | 1.2 (1.0 to 1.4) |
| gp70-700010058 IgG3 strain, at Day 182 | 11.9 (6.3 to 22.6) |
| gp70-700010058 IgG3 strain, at Day 672 | 1.3 (1.0 to 1.9) |
| gp70-700010058 IgG3 strain, at Year 14 | 2.9 (1.9 to 4.2) |
| gp70-7060101641 IgG3 strain, at Day 0 | 1.1 (1.0 to 1.2) |
| gp70-7060101641 IgG3 strain, at Day 182 | 3.7 (2.4 to 5.6) |
| gp70-7060101641 IgG3 strain, at Day 672 | 1.4 (1.1 to 1.9) |
| gp70-7060101641 IgG3 strain, at Year 14 | 1.0 (1.0 to 1.0) |
| gp70-96ZM651.02 IgG3 strain, at Day 0 | 1.4 (1.0 to 2.0) |
| gp70-96ZM651.02 IgG3 strain, at Day 182 | 1.8 (1.2 to 2.8) |
| gp70-96ZM651.02 IgG3 strain, at Day 672 | 1.2 (0.9 to 1.6) |
| gp70-96ZM651.02 IgG3 strain, at Year 14 | 1.6 (1.1 to 2.3) |
| gp70-BF1266_431a IgG3 strain, at Day 0 | 1.0 (1.0 to 1.0) |
| gp70-BF1266_431a IgG3 strain, at Day 182 | 13.2 (6.1 to 28.5) |
| gp70-BF1266_431a IgG3 strain, at Day 672 | 1.8 (1.1 to 3.2) |
| gp70-BF1266_431a IgG3 strain, at Year 14 | 1.5 (1.0 to 2.2) |
| gp70-BJOX002000.03.2 IgG3 strain, at Day 0 | 1.3 (1.0 to 1.6) |
| gp70-BJOX002000.03.2 IgG3 strain, at Day 182 | 4.7 (2.9 to 7.7) |
| gp70-BJOX002000.03.2 IgG3 strain, at Day 672 | 1.3 (1.0 to 1.7) |
| gp70-BJOX002000.03.2 IgG3 strain, at Year 14 | 1.6 (1.2 to 2.1) |
| gp70-C2101.c01 IgG3 strain, at Day 0 | 1.5 (0.9 to 2.5) |
| gp70-C2101.c01 IgG3 strain, at Day 182 | 4.7 (2.4 to 9.1) |
| gp70-C2101.c01 IgG3 strain, at Day 672 | 1.7 (1.0 to 3.0) |
| gp70-C2101.c01 IgG3 strain, at Year 14 | 1.9 (1.2 to 3.0) |
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 0 | 1.5 (1.0 to 2.2) |
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 182 | 5.9 (3.6 to 9.5) |
| gp70-CAP210.2.00.E8 IgG3 strain, at Day 672 | 1.6 (1.1 to 2.3) |
| gp70-CAP210.2.00.E8 IgG3 strain, at Year 14 | 2.1 (1.5 to 3.1) |
| gp70-CM244.ec1 IgG3 strain, at Day 0 | 1.5 (1.0 to 2.1) |
| gp70-CM244.ec1 IgG3 strain, at Day 182 | 4.5 (2.7 to 7.6) |
| gp70-CM244.ec1 IgG3 strain, at Day 672 | 1.5 (1.1 to 2.2) |
| gp70-CM244.ec1 IgG3 strain, at Year 14 | 4.0 (2.5 to 6.5) |
| gp70-Ce1086_B2 IgG3 strain, at Day 0 | 1.7 (1.1 to 2.8) |
| gp70-Ce1086_B2 IgG3 strain, at Day 182 | 3.0 (1.8 to 5.0) |
| gp70-Ce1086_B2 IgG3 strain, at Day 672 | 1.4 (1.0 to 2.1) |
| gp70-Ce1086_B2 IgG3 strain, at Year 14 | 1.4 (0.9 to 2.0) |
| gp70-RHPA4259.7 IgG3 strain, at Day 0 | 1.1 (0.9 to 1.3) |
| gp70-RHPA4259.7 IgG3 strain, at Day 182 | 4.0 (2.0 to 7.9) |
| gp70-RHPA4259.7 IgG3 strain, at Day 672 | 1.0 (1.0 to 1.1) |
| gp70-RHPA4259.7 IgG3 strain, at Year 14 | 1.2 (1.0 to 1.5) |
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 0 | 1.3 (1.0 to 1.7) |
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 182 | 9.9 (5.7 to 16.9) |
| gp70-TT31P.2F10.2792 IgG3 strain, at Day 672 | 1.5 (1.1 to 2.1) |
| gp70-TT31P.2F10.2792 IgG3 strain, at Year 14 | 1.1 (1.0 to 1.2) |
| gp70-TV1.21 IgG3 strain, at Day 0 | 1.6 (0.9 to 2.6) |
| gp70-TV1.21 IgG3 strain, at Day 182 | 11.4 (5.8 to 22.6) |
| gp70-TV1.21 IgG3 strain, at Day 672 | 1.9 (1.2 to 3.2) |
| gp70-TV1.21 IgG3 strain, at Year 14 | 2.9 (1.8 to 4.8) |
| gp70_B.CaseA IgG3 strain, at Day 0 | 1.2 (0.8 to 1.7) |
| gp70_B.CaseA IgG3 strain, at Day 182 | 58.2 (30.1 to 112.4) |
| gp70_B.CaseA IgG3 strain, at Day 672 | 2.8 (1.4 to 5.3) |
| gp70_B.CaseA IgG3 strain, at Year 14 | 1.7 (1.1 to 2.8) |
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 0 | 1.2 (0.8 to 2.0) |
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 182 | 89.4 (31.0 to 258.2) |
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Day 672 | 7.4 (3.1 to 18.0) |
| C.1086C_V1_V2 Tags IgG1 Qual strain, at Year 14 | 2.4 (1.3 to 4.7) |
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 0 | 1.1 (1.0 to 1.2) |
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 182 | 1.4 (0.9 to 2.1) |
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Day 672 | 1.4 (0.9 to 2.1) |
| C.1086C_V1_V2 Tags IgG2 Qual strain, at Year 14 | 1.3 (0.9 to 1.9) |
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 0 | 1.8 (1.2 to 2.7) |
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 182 | 5.0 (2.2 to 11.1) |
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Day 672 | 1.3 (1.0 to 1.6) |
| C.1086C_V1_V2 Tags IgG3 Qual strain, at Year 14 | 2.1 (1.6 to 2.8) |
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 0 | 1.2 (1.0 to 1.4) |
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 182 | 1.3 (1.1 to 1.6) |
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Day 672 | 1.3 (1.1 to 1.6) |
| C.1086C_V1_V2 Tags IgG4 Qual strain, at Year 14 | 1.0 (1.0 to 1.0) |
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.
| Participants | GSKSB732461 Group |
|---|---|
| 254008_D11gp120.avi/293FIgGQual strain, at Day 182 | 29 |
| 254008_D11gp120.avi/293FIgGQual strain, at Day 672 | 29 |
| 254008_D11gp120.avi/293FIgGQual strain, at Year 14 | 27 |
| 51802_D11gp120.avi/293F IgGQual strain, at Day 182 | 25 |
| 51802_D11gp120.avi/293F IgGQual strain, at Day 672 | 18 |
| 51802_D11gp120.avi/293F IgGQual strain, at Year 14 | 6 |
| A244 D11gp120_avi IgG Qual strain, at Day 182 | 25 |
| A244 D11gp120_avi IgG Qual strain, at Day 672 | 20 |
| A244 D11gp120_avi IgG Qual strain, at Year 14 | 8 |
| B.6240_D11gp120/293F IgG Qual strain, at Day 182 | 27 |
| B.6240_D11gp120/293F IgG Qual strain, at Day 672 | 23 |
| B.6240_D11gp120/293F IgG Qual strain, at Year 14 | 17 |
| BJOX002_D11gp120.avi/293FIgGQual strain,at Day 182 | 21 |
| BJOX002_D11gp120.avi/293FIgGQual strain,at Day 672 | 13 |
| BJOX002_D11gp120.avi/293FIgGQual strain,at Year 14 | 2 |
| BORI_D11gp120.avi/293F IgG Qual strain, at Day 182 | 26 |
| BORI_D11gp120.avi/293F IgG Qual strain, at Day 672 | 20 |
| BORI_D11gp120.avi/293F IgG Qual strain, at Year 14 | 10 |
| CNE20_D11gp120.avi/293F IgGQual strain, at Day 182 | 26 |
| CNE20_D11gp120.avi/293F IgGQual strain, at Day 672 | 23 |
| CNE20_D11gp120.avi/293F IgGQual strain, at Year 14 | 16 |
| TT31P.2792_D11gp120.avi/293FIgGQual, at Day 182 | 27 |
| TT31P.2792_D11gp120.avi/293FIgGQual, at Day 672 | 26 |
| TT31P.2792_D11gp120.avi/293FIgGQual, at Year 14 | 20 |
| 1086C_D7gp120.avi/293F IgG strain, at Day 182 | 27 |
| 1086C_D7gp120.avi/293F IgG strain, at Day 672 | 27 |
| 1086C_D7gp120.avi/293F IgG strain, at Year 14 | 22 |
| Con 6 gp120/B IgG strain, at Day 182 | 27 |
| Con 6 gp120/B IgG strain, at Day 672 | 25 |
| Con 6 gp120/B IgG strain, at Year 14 | 16 |
| gp120 (Clone W6.1D) IgG strain, at Day 182 | 27 |
| gp120 (Clone W6.1D) IgG strain, at Day 672 | 25 |
| gp120 (Clone W6.1D) IgG strain, at Year 14 | 19 |
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.
| MFI | GSKSB732461 Group |
|---|---|
| 254008_D11gp120.avi/293F IgG -BKG strain, at Day 0 | 2.5 (1.4 to 4.4) |
| 254008_D11gp120.avi/293FIgGQual strain, at Day 182 | 6796.7 (5926.0 to 7795.3) |
| 254008_D11gp120.avi/293FIgGQual strain, at day 672 | 1633.3 (1361.1 to 1959.9) |
| 254008_D11gp120.avi/293FIgGQual strain, at Year 14 | 479.6 (308.7 to 745.3) |
| 51802_D11gp120.avi/293F IgG -BKG strain, at Day 0 | 1.0 (1.0 to 1.0) |
| 51802_D11gp120.avi/293F IgGQual strain, at Day 182 | 993.7 (407.4 to 2424.1) |
| 51802_D11gp120.avi/293F IgGQual strain, at Day 672 | 74.8 (29.0 to 193.3) |
| 51802_D11gp120.avi/293F IgGQual strain, at Year 14 | 14.4 (5.7 to 36.4) |
| A244 D11gp120_avi IgG -BKG strain, at Day 0 | 1.4 (0.9 to 2.2) |
| A244 D11gp120_avi IgG Qual strain, at Day 182 | 990.2 (498.3 to 1967.7) |
| A244 D11gp120_avi IgG Qual strain, at Day 672 | 124.4 (50.2 to 308.2) |
| A244 D11gp120_avi IgG Qual strain, at Year 14 | 39.8 (17.6 to 90.2) |
| B.6240_D11gp120/293F IgG -BKG strain, at Day 0 | 1.0 (1.0 to 1.0) |
| B.6240_D11gp120/293F IgG Qual strain, at Day 182 | 8760.5 (6725.8 to 11410.7) |
| B.6240_D11gp120/293F IgG Qual strain, at Day 672 | 634.2 (265.8 to 1513.3) |
| B.6240_D11gp120/293F IgG Qual strain, at Year 14 | 132.8 (53.6 to 329.1) |
| BJOX002_D11gp120.avi/293F IgG-BKG strain, at Day 0 | 1.1 (0.9 to 1.3) |
| BJOX002_D11gp120.avi/293FIgGQual strain,at Day 182 | 250.6 (109.9 to 571.6) |
| BJOX002_D11gp120.avi/293FIgGQual strain,at Day 672 | 31.2 (13.8 to 70.6) |
| BJOX002_D11gp120.avi/293FIgGQual strain,at Year 14 | 9.9 (4.5 to 21.9) |
| BORI_D11gp120.avi/293F IgG -BKG strain, at Day 0 | 1.0 (1.0 to 1.0) |
| BORI_D11gp120.avi/293F IgG Qual strain, at Day 182 | 2811.9 (1546.5 to 5112.6) |
| BORI_D11gp120.avi/293F IgG Qual strain, at Day 672 | 148.9 (57.1 to 388.5) |
| BORI_D11gp120.avi/293F IgG Qual strain, at Year 14 | 35.5 (13.8 to 91.4) |
| CNE20_D11gp120.avi/293F IgG -BKG strain, at Day 0 | 1.1 (0.9 to 1.5) |
| CNE20_D11gp120.avi/293F IgGQual strain, at Day 182 | 2925.8 (1336.2 to 6406.5) |
| CNE20_D11gp120.avi/293F IgGQual strain, at Day 672 | 587.3 (295.6 to 1166.9) |
| CNE20_D11gp120.avi/293F IgGQual strain, at Year 14 | 126.0 (55.6 to 285.5) |
| TT31P.2792_D11gp120.avi/293FIgGBKG strain,at Day 0 | 1.6 (0.9 to 2.7) |
| TT31P.2792_D11gp120.avi/293FIgGQual, at Day 182 | 20622.9 (18541.3 to 22938.2) |
| TT31P.2792_D11gp120.avi/293FIgGQual, at Day 672 | 3372.5 (1788.3 to 6360.1) |
| TT31P.2792_D11gp120.avi/293FIgGQual, at Year 14 | 568.6 (253.3 to 1276.5) |
| 1086C_D7gp120.avi/293F IgG strain, at Day 0 | 1.1 (0.9 to 1.4) |
| 1086C_D7gp120.avi/293F IgG strain, at Day 182 | 27145.5 (26416.5 to 27894.7) |
| 1086C_D7gp120.avi/293F IgG strain, at Day 672 | 17448.6 (14249.1 to 21366.6) |
| 1086C_D7gp120.avi/293F IgG strain, at Year 14 | 4253.8 (3218.3 to 5622.4) |
| Con 6 gp120/B IgG strain, at Day 0 | 1.8 (1.2 to 2.6) |
| Con 6 gp120/B IgG strain, at Day 182 | 10618.0 (8540.0 to 13201.6) |
| Con 6 gp120/B IgG strain, at Day 672 | 879.2 (422.1 to 1831.4) |
| Con 6 gp120/B IgG strain, at Year 14 | 176.8 (76.6 to 408.1) |
| gp120 (Clone W6.1D) IgG strain, at Day 0 | 1.1 (0.9 to 1.3) |
| gp120 (Clone W6.1D) IgG strain, at Day 182 | 25617.4 (24497.6 to 26788.4) |
| gp120 (Clone W6.1D) IgG strain, at Day 672 | 3027.1 (1293.7 to 7083.2) |
| gp120 (Clone W6.1D) IgG strain, at Year 14 | 544.6 (236.5 to 1253.7) |
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.
| Participants | GSKSB732461 Group |
|---|---|
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 182 | 28 |
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 672 | 27 |
| 1086C_D7gp120.avi/293F IgG1 strain, at Year 14 | 23 |
| Con 6 gp120/B IgG1 strain, at Day 182 | 28 |
| Con 6 gp120/B IgG1 strain, at Day 672 | 22 |
| Con 6 gp120/B IgG1 strain, at Year 14 | 11 |
| gp120 (Clone W6.1D) IgG1 strain, at Day 182 | 28 |
| gp120 (Clone W6.1D) IgG1 strain, at Day 672 | 25 |
| gp120 (Clone W6.1D) IgG1 strain, at Year 14 | 16 |
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 182 | 0 |
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 672 | 0 |
| 1086C_D7gp120.avi/293F IgG2 strain, at Year 14 | 0 |
| Con 6 gp120/B IgG2 strain, at Day 182 | 0 |
| Con 6 gp120/B IgG2 strain, at Day 672 | 0 |
| Con 6 gp120/B IgG2 strain, at Year 14 | 0 |
| gp120 (Clone W6.1D) IgG2 strain, at Day 182 | 0 |
| gp120 (Clone W6.1D) IgG2 strain, at Day 672 | 0 |
| gp120 (Clone W6.1D) IgG2 strain, at Year 14 | 0 |
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 182 | 25 |
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 672 | 21 |
| 1086C_D7gp120.avi/293F IgG3 strain, at Year 14 | 9 |
| Con 6 gp120/B IgG3 strain, at Day 182 | 9 |
| Con 6 gp120/B IgG3 strain, at Day 672 | 0 |
| Con 6 gp120/B IgG3 strain, at Year 14 | 0 |
| gp120 (Clone W6.1D) IgG3 strain, at Day 182 | 19 |
| gp120 (Clone W6.1D) IgG3 strain, at Day 672 | 3 |
| gp120 (Clone W6.1D) IgG3 strain, at Year 14 | 1 |
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 182 | 6 |
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 672 | 5 |
| 1086C_D7gp120.avi/293F IgG4 strain, at Year 14 | 7 |
| Con 6 gp120/B IgG4 strain, at Day 182 | 1 |
| Con 6 gp120/B IgG4 strain, at Day 672 | 2 |
| Con 6 gp120/B IgG4 strain, at Year 14 | 2 |
| gp120 (Clone W6.1D) IgG4 strain, at Day 182 | 8 |
| gp120 (Clone W6.1D) IgG4 strain, at Day 672 | 3 |
| gp120 (Clone W6.1D) IgG4 strain, at Year 14 | 3 |
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.
| MFI | GSKSB732461 Group |
|---|---|
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 0 | 1.0 (1.0 to 1.0) |
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 182 | 10365.4 (9153.8 to 11737.5) |
| 1086C_D7gp120.avi/293F IgG1 strain, at Day 672 | 2834.1 (1991.6 to 4033.1) |
| 1086C_D7gp120.avi/293F IgG1 strain, at Year 14 | 371.0 (158.9 to 866.0) |
| Con 6 gp120/B IgG1 strain, at Day 0 | 1.0 (1.0 to 1.1) |
| Con 6 gp120/B IgG1 strain, at Day 182 | 4396.8 (3618.2 to 5343.0) |
| Con 6 gp120/B IgG1 strain, at Day 672 | 246.0 (95.6 to 632.9) |
| Con 6 gp120/B IgG1 strain, at Year 14 | 21.5 (8.2 to 55.9) |
| gp120 (Clone W6.1D) IgG1 strain, at Day 0 | 1.0 (1.0 to 1.0) |
| gp120 (Clone W6.1D) IgG1 strain, at Day 182 | 11572.9 (9525.5 to 14060.3) |
| gp120 (Clone W6.1D) IgG1 strain, at Day 672 | 653.3 (359.5 to 1187.2) |
| gp120 (Clone W6.1D) IgG1 strain, at Year 14 | 47.0 (18.1 to 122.1) |
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 0 | 1.2 (1.1 to 1.4) |
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 182 | 2.6 (1.7 to 3.9) |
| 1086C_D7gp120.avi/293F IgG2 strain, at Day 672 | 2.4 (1.6 to 3.6) |
| 1086C_D7gp120.avi/293F IgG2 strain, at Year 14 | 1.1 (1.0 to 1.2) |
| Con 6 gp120/B IgG2 strain, at Day 0 | 1.1 (1.0 to 1.2) |
| Con 6 gp120/B IgG2 strain, at Day 182 | 1.3 (1.1 to 1.6) |
| Con 6 gp120/B IgG2 strain, at Day 672 | 1.4 (1.1 to 1.7) |
| Con 6 gp120/B IgG2 strain, at Year 14 | 1.3 (1.1 to 1.6) |
| gp120 (Clone W6.1D) IgG2 strain, at Day 0 | 1.0 (1.0 to 1.0) |
| gp120 (Clone W6.1D) IgG2 strain, at Day 182 | 1.9 (1.3 to 2.9) |
| gp120 (Clone W6.1D) IgG2 strain, at Day 672 | 1.5 (1.1 to 2.0) |
| gp120 (Clone W6.1D) IgG2 strain, at Year 14 | 1.1 (0.9 to 1.4) |
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 0 | 1.5 (1.1 to 2.0) |
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 182 | 417.1 (302.7 to 574.8) |
| 1086C_D7gp120.avi/293F IgG3 strain, at Day 672 | 206.3 (150.4 to 283.1) |
| 1086C_D7gp120.avi/293F IgG3 strain, at Year 14 | 42.8 (22.4 to 81.8) |
| Con 6 gp120/B IgG3 strain, at Day 0 | 1.1 (1.0 to 1.2) |
| Con 6 gp120/B IgG3 strain, at Day 182 | 60.8 (41.5 to 89.0) |
| Con 6 gp120/B IgG3 strain, at Day 672 | 11.0 (6.5 to 18.6) |
| Con 6 gp120/B IgG3 strain, at Year 14 | 2.9 (1.9 to 4.3) |
| gp120 (Clone W6.1D) IgG3 strain, at Day 0 | 1.1 (1.0 to 1.2) |
| gp120 (Clone W6.1D) IgG3 strain, at Day 182 | 161.9 (111.2 to 235.6) |
| gp120 (Clone W6.1D) IgG3 strain, at Day 672 | 24.3 (14.7 to 40.3) |
| gp120 (Clone W6.1D) IgG3 strain, at Year 14 | 7.8 (4.3 to 14.3) |
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 0 | 1.2 (1.0 to 1.4) |
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 182 | 47.0 (30.4 to 72.7) |
| 1086C_D7gp120.avi/293F IgG4 strain, at Day 672 | 30.1 (16.9 to 53.6) |
| 1086C_D7gp120.avi/293F IgG4 strain, at Year 14 | 20.3 (9.9 to 41.5) |
| Con 6 gp120/B IgG4 strain, at Day 0 | 1.0 (1.0 to 1.0) |
| Con 6 gp120/B IgG4 strain, at Day 182 | 14.9 (9.7 to 22.7) |
| Con 6 gp120/B IgG4 strain, at Day 672 | 6.6 (3.9 to 11.3) |
| Con 6 gp120/B IgG4 strain, at Year 14 | 4.7 (2.5 to 8.6) |
| gp120 (Clone W6.1D) IgG4 strain, at Day 0 | 1.1 (1.0 to 1.2) |
| gp120 (Clone W6.1D) IgG4 strain, at Day 182 | 52.8 (36.7 to 75.8) |
| gp120 (Clone W6.1D) IgG4 strain, at Day 672 | 21.3 (12.9 to 35.3) |
| gp120 (Clone W6.1D) IgG4 strain, at Year 14 | 10.4 (5.8 to 18.8) |
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.
| CD4+ T-cells/million cells | GSKSB732461 Group |
|---|---|
| At Day 0 | 0.00 (0.00 to 0.01) |
| At Day 98 | 0.42 (0.30 to 0.78) |
| At Day 672 | 0.32 (0.21 to 0.43) |
| At Year 14 | 0.21 (0.14 to 0.35) |
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.
| Participants | GSKSB732461 Group |
|---|---|
| At Day 98 | 25 |
| At Day 672 | 23 |
| At Year 14 | 22 |
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.
| CD8+ T-cells/million cells | GSKSB732461 Group |
|---|---|
| At Day 0 | 0.00 (0.00 to 0.01) |
| At Day 98 | 0.00 (0.00 to 0.01) |
| At Day 672 | 0.00 (0.00 to 0.01) |
| At Year 14 | 0.00 (0.00 to 0.01) |
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.
| Participants | GSKSB732461 Group |
|---|---|
| At Day 98 | 0 |
| At Day 672 | 0 |
| At Year 14 | 0 |
Collected over Serious adverse events were reported during the whole study period (single study visit, at Year 14). Adverse events were not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSKSB732461 Group | 0/36 (0%) | 0/36 (0%) | — |
| Age, Continuous(Years) | GSKSB732461 Group |
|---|---|
| Mean | 43.5 ± 8.6 |
| Sex: Female, Male(Participants) | GSKSB732461 Group |
|---|---|
| Female | 13 |
| Male | 23 |
| Race/Ethnicity, Customized(Participants) | GSKSB732461 Group |
|---|---|
| WHITE - CAUCASIAN / EUROPEAN HERITAGE | 35 |
| BLACK OR AFRICAN AMERICAN | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Dec 2017 to primary completion in Jan 2018, 1 month.
Results were first posted in Nov 2019, 1 year 9 months after primary completion.
Of 74 industry-sponsored phase 1 interventional studies under HIV Infections, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's 1 month is below that.
Counting every sponsor, half of 165 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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