IMPAACT 2049 / LEAP

IMPAACT 2049 is a Phase IIA randomized, double-blinded, placebo-controlled study of the safety and immunogenicity of ID93-GLA-SE in pre-adolescents living with and without HIV in South Africa (LEAP).  The study is designed to evaluate the safety of ID93-GLA-SE vaccination through Week 48 and the immunogenicity of ID93-GLA-SE vaccination through Week 10 in pre-adolescents (9-14 years of age, inclusive) for a total of 48 weeks. IMPAACT- and HVTN-affiliated sites in South Africa will be invited to participate to ensure consistency of the BCG vaccine strain received by participants at birth.