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Phase I/II Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination against Tuberculosis in Pre-Adolescents Living with and without HIV in South Africa (LEAP)

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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.

Site selection was completed in September 2021. IMPAACT- and HVTN-affiliated sites in South Africa were invited to participate to ensure consistency of the BCG vaccine strain received by participants at birth and to optimize specimen processing and shipping to the testing laboratory in South Africa.

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