A Study to Evaluate Safety and Immunogenicity of AERAS-402
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 Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- Number and Percentage of Adverse Events by treatment group [ Time Frame: Day 56 ] [ Designated as safety issue: Yes ]The number and percentage of Adverse Events will be presented and compared by treatment group (placebo vs AERAS 402).
- Immune Response [ Time Frame: Day 182 ] [ Designated as safety issue: No ]Percentage of CD4 and CD8 cells producing specific cytokines will be measured and tabulated in subjects who have received the vaccine.
|Study Start Date:||February 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo Arm||
0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28
Active Comparator: AERAS 402 Arm
Biological: AERAS 402
0.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28