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IMPAACT 2035/HVTN 604
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)
Study Status
In Development
DAIDS Number
38846
Primary Protocol Team Members
Summary
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.
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