Last updated: 09/25/2020 13:50:04

Long-term immunogenicity of the HIV gp120-NefTat/AS01B vaccine (GSK SB732461)

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GSK study ID
201606
Clinicaltrials.gov ID
NCT03368053
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Long-term immunogenicity of the HIV gp120-NefTat/AS01B vaccine (GSK SB732461)
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects with anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) response call

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

Anti-V1V2 Total IgG antibody BAMA response magnitude

Timeframe: 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

Timeframe: 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

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

Secondary outcomes:

Number of subjects with anti-envelope glycoprotein (anti-gp) 120 Total IgG BAMA response call

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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

Interventions:
  • Procedure/surgery: Blood sampling
    • Enrollment:
    36
    Primary completion date:
    2018-30-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical 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, Romana F. Persistence of vaccine-elicited immune response up to 14 years post-HIV gp120-NefTat/AS01B vaccination. Vaccine. 2020. 38(7):1678-1689.
    Medical condition
    Infection, Human Immunodeficiency Virus
    Product
    SB732461
    Collaborators
    Ghent University
    Study date(s)
    December 2017 to January 2018
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    30 - 65 years
    Accepts healthy volunteers
    Yes
    • 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.
    • Use of any investigational or non-registered product during 30 days prior to study enrolment.
    • History of HIV-1 or HIV-2 infection.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2018-30-01
    Actual study completion date
    2018-30-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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