Clinical Trial: A Phase I/IIa Safety & Immunogenicity of AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional




Official Title: A Phase I/IIa Double-Blind, Randomized, Placebo-controlled Dose-Finding Study to Evaluate the Safety and Immunogenicity of AERAS-456 in HIV-Negative Adults With and Without Laten

Brief Summary: This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by IM injection.