Status:
COMPLETED
Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
University Ghent
Conditions:
Infection, Human Immunodeficiency Virus
HIV Infections
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
Brief 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)-negat...
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03368053
Start Date
December 14 2017
End Date
January 30 2018
Last Update
October 20 2020
Active Locations (1)
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1
GSK Investigational Site
Ghent, Belgium, 9000