At a glance
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A Phase II, Proof of Concept, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Protective Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in Healthy, HIV-infected Adults
In Brief
A Phase 2 clinical trial evaluating MVA85A/AERAS-485 and Placebo for Tuberculosis and HIV Infections. Completed, enrolled 650 participants across 2 sites in 2 countries.
Detailed Summary
This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults. This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity analysis set).
Study Details
Timeline
Interventions
Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485.
Subjects received an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.