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IMPAACT 2039
Phase I/II Study of the Safety, Immunogenicity, and Efficacy of HIVconsvX Vaccines and Broadly Neutralizing Antibodies in Children Living with HIV
Primary Protocol Team Members
Summary
IMPAACT 2039 is a Phase I/II randomized study of an HIV vaccine regimen in combination with broadly neutralizing antibodies (bNAbs) in children living with HIV. The study will be conducted in two parts:
- Preliminary safety and pharmacokinetics (PK) will be evaluated in Part A.
- Safety, PK, and efficacy in controlling viral replication will be evaluated in Part B.
Approximately 68 children 5-11 years of age are expected to take part in the study at selected sites. Site selection occurred in May 2023 and was opened to IMPAACT sites located in HIV clade B and clade C settings.
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