A Study to Evaluate Safety and Immunogenicity of AERAS-402
|ClinicalTrials.gov Identifier: NCT01378312|
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : March 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Biological: AERAS 402 Biological: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2011|
|Primary Completion Date :||October 2011|
|Study Completion Date :||March 2012|
|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
- Number and Percentage of Adverse Events by treatment group [ Time Frame: Day 56 ]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 ]Percentage of CD4 and CD8 cells producing specific cytokines will be measured and tabulated in subjects who have received the vaccine.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378312
|Principal Investigator:||Vanya Dhagat, MD||Lotus Labs|