Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine

Phase 1

Completed

• Conditions: AIDS
• Interventions: Procedure: Blood collection; Biological: GSK HIV vaccine 732462

• Registration Number: NCT01092611
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

Detailed Description

General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.

Study Timeline

• Study Start: 2010-03-22
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-25
• Primary Completion: 2014-03-17
• Study Completion: 2014-05-19
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:

• HIV-infected subject.
• Previous participation in a study evaluating GSK HIV vaccine 732462.
• Written informed consent obtained from the subject.

Exclusion Criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Subjects who did not receive a complete vaccination course in previous studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Blood collection	Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study
Group A	GSK HIV vaccine 732462	Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study
Group B	Blood collection	Subjects who were administered placebo in primary studies and who accepted to participate in this study

Primary Outcome Measures

Name	Time	Method
Occurrence of each separate defining condition for HIV-disease progression	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)	Once a year after Visit 1 (during a maximum of 4 years)
CD4 count	Once a year after Visit 1 (during a maximum of 4 years)
Viral load (VL) and method of measurement	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of HIV disease progression	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of adverse events (AEs) or serious adverse events (SAEs) considered by the Investigator to be related to vaccination (performed in the preceding vaccination study)	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of specific clinical events and death	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of potential immune-mediated diseases (pIMDs)	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of SAEs related to study participation	Once a year after Visit 1 (during a maximum of 4 years)

Secondary Outcome Measures

Name	Time	Method
Time between dose 1 and ART (re)-initiation or ART modification	Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and CD4 count measurement	Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and VL measurement	Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and occurrence of HIV disease progression	Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression	Once a year after Visit 1 (during a maximum of 4 years)
Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays)	Once a year after Visit 1 (during a maximum of 4 years)
Antibody concentrations to vaccine antigens	Once a year after Visit 1 (during a maximum of 4 years)
Cell-mediated immunity responses	Once a year after Visit 1 (during a maximum of 4 years)

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Valencia, Spain