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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus; HIV Infections

Treatments: Procedure: Blood sampling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03368053

201606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

GSKSB732461 Group

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling