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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
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).
Details
| Lead sponsor | Aeras |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 650 |
| Start date | 2011-07 |
| Completion | 2014-09 |
Conditions
- Tuberculosis
- HIV Infections
Interventions
- MVA85A/AERAS-485
- Placebo
Primary outcomes
- Percentage of Participants With Adverse Events — Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination.
The primary objective of this study is to evaluate the safety of MVA85A/AERAS-485 compared to placebo in HIV-infected, African adult subjects without active TB disease.
Countries
Senegal, South Africa