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Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults

Tuberculosis Clinical Trial

Official title:
Safety and Immunogenicity of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to HIV-positive Adults Living in a Tuberculosis Endemic Region

Clinical Trial Summary

The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis endemic region.

Subjects will be followed-up for 3 years.

Subjects will be enrolled in 3 cohorts:

- HIV-positive adults on highly active antiretroviral therapy

- HIV-positive adults not on highly active antiretroviral therapy

- HIV-negative adults

Each cohort will have 2 groups.

Clinical Trial Description

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the outcome measures and the inclusion and exclusion criteria. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01262976
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date January 17, 2011
Completion date June 4, 2015
View Details
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