Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Open Label Dose-Escalation Study to Evaluate the Safety and Immunogenicity of H56:IC31 (AERAS-456) in HIV-negative Adults With and Without Latent Tuberculosis Infe
Brief Summary: This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have LTBI and 8 of whom will not have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by intramuscular injection.