Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Blood sampling
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention model description: Descriptive mono-centric study with one single group.
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: gp120; HIV infections; RV144; gp120-NefTat/AS01B vaccine candidate; V1V2

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. Other immune parameters like the HIV-specific cluster of differentiation
      (CD4+) T cell and CD8+ T cell responses will also be evaluated.
    

Eligibility 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.