In a Phase 1 clinical trial, 48 healthy adults will receive a total of two doses administered IM on Days 0 and 56. Subjects will be monitored for approximately 421 days (one year following the last study injection), including safety laboratory analyses done just prior to and 7 days following each study injection.

Tears and nasal swabs will be obtained for exploratory antibody analysis at Days 0, 70, and 224.

Blood samples will be obtained for immunological assays (secondary and exploratory) at Days 0, 7, 14, 56, 63, 70, 84, and 224).

Results

AAHI published the results of the Phase 1 clinical trial.  In this trial, the novel single-vial presentation of this freeze-dried TB vaccine candidate elicited a stronger immune response than the administration of the same vaccine using separate vials of antigen and liquid adjuvant formulation. AAHI’s single-vial TB vaccine candidate represents significant progress in global efforts to combat TB.