Infection, Human Immunodeficiency VirusPhase 1NCT03368053

Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)

A Phase 1 study testing Blood sampling in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Infection, Human Immunodeficiency Virus, HIV Infections
What is being tested?: Blood sampling
Type of treatment: Vaccines, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteBelgium
Study dates: 14 Dec 2017to 30 Jan 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Read the 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.

Conditions: Infection, Human Immunodeficiency Virus, HIV Infections
Being tested: Blood sampling
Keywords: gp120, HIV infections, RV144, gp120-NefTat/AS01B vaccine candidate, V1V2
Medical subject headings: Infections, Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood samplingProcedure or surgery
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.

Study groups in NCT03368053
Study group	Role	What they receive
GSKSB732461 Group	Experimental	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. Receives: Procedure: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 201730 Jan 2018

First posted11 Dec 2017
Study start14 Dec 2017
Primary completion30 Jan 2018
Study completion30 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: Descriptive mono-centric study with one single group.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03368053
Sponsor's protocol ID: 201606
Status last verified: Sep 2020
First submitted: 5 Dec 2017
Last updated: 20 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Van Der Meeren O, Jongert E, Seaton KE, Koutsoukos M, Aerssens A, Brackett C, Debois M, Janssens M, Leroux-Roels G, Mesia Vela D, Sawant S, Yates NL, Tomaras GD, Leroux-Roels I, Roman F. Persistence of vaccine-elicited immune response up to 14 years post-HIV gp120-NefTat/AS01B vaccination. Vaccine. 2020 Feb 11;38(7):1678-1689. doi: 10.1016/j.vaccine.2019.12.058. Epub 2020 Jan 10.
PubMed 31932137
Offoh PI, Azupogo F, Brouwer ID, Cazarin CBB. Baseline Diet Quality Indicators and Six-Month Changes in Iron and Vitamin A Biomarkers among Rural Ghanaian Adolescents: A Secondary Analysis of the Ten2Twenty-Ghana Trial. Am J Clin Nutr. 2026 Aug 18:101480. doi: 10.1016/j.ajcnut.2026.101480. Online ahead of print.
PubMed 42612731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI

All Infection, Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
ClinicalTrials.gov ID: NCT03368053
Acronym / sponsor ID: 201606
Conditions: Infection, Human Immunodeficiency Virus, HIV Infections
Keywords: gp120, HIV infections, RV144, gp120-NefTat/AS01B vaccine candidate, V1V2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: University Ghent
Study start: 14 Dec 2017 (actual)
Primary completion: 30 Jan 2018 (actual)
Study completion: 30 Jan 2018 (actual)
First posted: 11 Dec 2017 (actual)
Results: Posted 18 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Descriptive mono-centric study with one single group.

Arm	Type	Receives
GSKSB732461 Group	Experimental	Procedure: Blood samplingHealthy 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.

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood samplingBlood 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.	Procedure or surgery	GSKSB732461 Group

Primary outcome

Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

8 secondary outcomes

Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
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
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
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
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
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
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
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
Time frame: At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14

Results and safety

Results posted to the registry on 18 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSKSB732461 Group	36	36

Primary outcome: Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call

Time frame: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14. Count of participants. Unit: Participants

Measure	GSKSB732461 Group n = 27
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

Population analysed: 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.

Primary outcome: Anti-V1V2 Total IgG Antibody BAMA Response Magnitude

Time frame: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14. Geometric mean (95% Confidence Interval). Unit: MFI

Measure	GSKSB732461 Group n = 32
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)

Primary outcome: Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call

Time frame: At Day 182, Day 672 historical time point of PRO-HIV-002 and at Year 14. Count of participants. Unit: Participants

Measure	GSKSB732461 Group n = 29
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

Primary outcome: Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude

Time frame: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14. Geometric mean (95% Confidence Interval). Unit: MFI

Measure	GSKSB732461 Group n = 34
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)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were reported during the whole study period (single study visit, at Year 14). Adverse events were not collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSKSB732461 Group	0 of 36 (0%)	0 of 0	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31932137Van Der Meeren O, Jongert E, Seaton KE, Koutsoukos M, Aerssens A, Brackett C, Debois M, Janssens M, Leroux-Roels G, Mesia Vela D, Sawant S, Yates NL, Tomaras GD, Leroux-Roels I, Roman F. Persistence of vaccine-elicited immune response up to 14 years post-HIV gp120-NefTat/AS01B vaccination. Vaccine. 2020 Feb 11;38(7):1678-1689. doi: 10.1016/j.vaccine.2019.12.058. Epub 2020 Jan 10.
Derived from this study: PubMed 42612731Offoh PI, Azupogo F, Brouwer ID, Cazarin CBB. Baseline Diet Quality Indicators and Six-Month Changes in Iron and Vitamin A Biomarkers among Rural Ghanaian Adolescents: A Secondary Analysis of the Ten2Twenty-Ghana Trial. Am J Clin Nutr. 2026 Aug 18:101480. doi: 10.1016/j.ajcnut.2026.101480. Online ahead of print.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Infection, Human Immunodeficiency Virus

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Blood sampling in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by GlaxoSmithKline at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call (time frame: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03368053, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.