Trial intelligence / Profile preview

Safety and Immunogenicity of GSK's TB Vaccine (692342) in Healthy Adults

NCT00600782Phase 2

Key facts

Status: Completed
Start: Feb 2008
Primary completion: Dec 2008
Countries: 1
Sponsor: GSK
Modality: Vaccines & Immunotherapeutics

Drugs: M72 + AS01E
Conditions: Tuberculosis (TB)

Overview

Phase 2, open-label, single-arm trial of M72 + AS01E in Tuberculosis (TB), sponsored by GSK. Primary endpoints: Occurrence, intensity and relationship to vaccination of solicited local and general symptoms, Occurrence, intensity and relationship to vaccination of unsolicited symptoms and 2 more. Started Feb 2008; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

M72/AS01 Vaccine Group
Subjects receiving 2 doses of M72/AS01 vaccine at 0 and 1 month, stratified by PPD reaction.

Who it enrols

Healthy adults aged 21-40 living in a TB-endemic region with appropriate PPD skin reactivity, no evidence of pulmonary pathology, and seronegative for HIV.

Endpoints

Primary

Occurrence, intensity and relationship to vaccination of solicited local and general symptoms7 days post-vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms30 days post-vaccination
Occurrence and relationship to vaccination of serious adverse eventsEntire study period
Haematological and biochemical levelsProtocol defined time points

Secondary

Analysis of cytokine expression by M72-specific CD4+/CD8+ T cellsProtocol defined time points
Antibody titres to M72Protocol defined time points

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