IMPAACT 2035/HVTN 604

IMPAACT 2035/HVTN 604: LEAP (Leveraging Early Adolescence to Prevent TB) is a Phase I/II double-blinded, placebo-controlled, randomized (1:1:1) multi-center study of the novel TB vaccine candidate VPM1002 and BCG re-vaccination. The study is designed to evaluate the safety and immunogenicity of VPM1002 vaccination and BCG re-vaccination over 12 months in pre-adolescents with and without HIV and with and without Mycobacterium tuberculosis sensitization who have previously received a birth dose of BCG vaccine.