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

September 25, 2020 updated by: GlaxoSmithKline
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

GlaxoSmithKline (GSK) contributes to the public-private pox-protein partnership (P5) which is currently assessing the safety, immunogenicity and clinical efficacy of a prime-boost regimen aimed at preventing HIV transmission (http://www.hvtn.org/en.html). The booster component of the candidate vaccine used in this program consists of two gp120 clade C proteins administered with an adjuvant. In order to inform the selection of the adjuvant in future studies, data on long-term persistence of immunity after vaccination with gp120/AS01 would prove useful. The present study was designed to address this question using a cohort of volunteers vaccinated several years ago with a candidate vaccine containing gp120 and AS01.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GSKSB732461 Group
Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
Procedure: Blood sampling
Blood samples will be taken during the single study visit at Year 14 for the assessment of: HIV testing, antibody determination, cell mediated immune (CMI) responses and exploratory characterisation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
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.
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
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.
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
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.
At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings