Tuberculosis Clinical Trial
Official title:
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-402 When Administered to HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study
in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of
tuberculosis infection. The study will be conducted at one clinical research site in India.
The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete
protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or
"booster", while not toxic, does not provide much additional protection. AERAS-402 presents
tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus
vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis.
Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated,
AERAS-402 will be administered to individuals already vaccinated with BCG.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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