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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 100 children 3-12 years of age are expected to take part in the study at selected sites.
Site selection was initiated in May 2023 and was opened to IMPAACT sites located in HIV clade B and clade C settings, including sites in the following countries: Botswana, Brazil, Haiti, India, Malawi, South Africa, United States, and Zimbabwe.
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