A Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QFT (+) and (-) Adults Without Evidence of TB

Summary

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 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 in Kenya who have already been vaccinated with BCG.

Timeline

Start

2008-09

Primary completion

2009-06

Completion

2010-07

Publications

• Background Walsh DS, Owira V, Polhemus M, Otieno L, Andagalu B, Ogutu B, Waitumbi J, Hawkridge A, Shepherd B, Pau MG, Sadoff J, Douoguih M, McClain JB; Aeras C-012-402 Study Team. Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON((R))-TB Gold (+) Kenyan adults without evidence of tuberculosis. Vaccine. 2016 May 5;34(21):2430-2436. doi: 10.1016/j.vaccine.2016.03.069. Epub 2016 Mar 26.

Drugs

Indications