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Long-term Follow-up of Partic...

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

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-22

Study Completion Date

2014-05-19

Brief Summary

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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.

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Detailed Description

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

Conditions

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AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type OTHER

Blood collection

Intervention Type PROCEDURE

Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

GSK HIV vaccine 732462

Intervention Type BIOLOGICAL

No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.

Group B

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

Group Type OTHER

Blood collection

Intervention Type PROCEDURE

Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

Interventions

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Blood collection

Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

Intervention Type PROCEDURE

GSK HIV vaccine 732462

No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers