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ARTICLE | Clinical News

AERAS-456: Phase I/IIa started

November 18, 2013 8:00 AM UTC

Not-for-profit Aeras and the Danish government institute said the South African Tuberculosis Vaccine Initiative (SATVI) began a 2-part, double-blind, South African Phase I/IIa trial to evaluate 3 doses of AERAS-456 containing 5, 15 or 50 µg H56 antigen and 500 nmol IC31 in 98 HIV-negative subjects with and without latent TB infection. The first part of the trial will enroll 50 subjects without latent TB infection to receive AERAS-456 or placebo on days 0 and 56. The second part will enroll 48 subjects with and without latent TB infection to receive the optimal dose of AERAS-456 or placebo on either days 0 and 56 or days 0, 56 and 112. ...