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IMPAACT 2048

Phase I Study of the Safety and Pharmacokinetics of VRC07-523LS, ePGT121v1-LS, and PDGM1400LS Alone and in Combination in Breastfeeding Infants

Summary

IMPAACT 2048 is a phase I, open-label study of the broadly neutralizing monoclonal antibodies (bNAbs) VRC07-523LS, ePGT121v1-LS, and PDGM1400LS. The study is designed to evaluate the safety and pharmacokinetics of these bNAbs administered alone and in combination to breastfeeding infants. Infants will receive bNAb(s) at birth, 12 weeks, and 24 weeks and will remain in follow-up for a total of approximately 18 months. Site selection will be initiated as protocol development progresses and is expected to include sites in the United States and Africa.

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