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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
12
0.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28
0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28
Lotus Labs
Bangalore, Bangalore, India
Number and Percentage of Adverse Events by treatment group
The number and percentage of Adverse Events will be presented and compared by treatment group (placebo vs AERAS 402).
Time frame: Day 56
Immune Response
Percentage of CD4 and CD8 cells producing specific cytokines will be measured and tabulated in subjects who have received the vaccine.
Time frame: Day 182
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