NCT01378312

A Study to Evaluate Safety and Immunogenicity of AERAS-402

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	AERAS 402	0.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28
BIOLOGICAL	Placebo	0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-10-01
• Completion: 2012-03-01
• First posted: 2011-06-22
• Last updated: 2014-03-17

Locations

1 site across 1 country: India