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IMPAACT 2049 / LEAP

Phase IIA Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of ID93/GLA-SE in Pre-Adolescents Living with and without HIV (LEAP)

Study Status

In Development

DAIDS Number

TBA

IND Number

Non-IND

Clinical Trials Link

TBD

Summary

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 (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 will be invited to participate.

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