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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: AIDS

Treatments: Procedure: Blood collection; Biological: GSK HIV vaccine 732462

Study type: Interventional

Funder types: Industry

Identifiers

NCT01092611

2009-018097-64 (EudraCT Number)

114083

Details and patient eligibility

About

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.

Full description

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

Enrollment: 190 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Group A

Other group

Description:

Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study

Treatment:

Procedure: Blood collection

Biological: GSK HIV vaccine 732462

Group B

Other group

Description:

Subjects who were administered placebo in primary studies and who accepted to participate in this study

Treatment:

Procedure: Blood collection