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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-14

Study Completion Date

2018-01-30

Brief Summary

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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.

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Detailed Description

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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

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Infection, Human Immunodeficiency Virus HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Descriptive mono-centric study with one single group.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes