Development And Production Of A Multiclade Hiv-1 Dna Pla

Niaid Extramural Activities

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Abstract

This project is designed to prepare a GMP quality investigational HIV vaccine and complete the preclinical and laboratory studies needed to begin a clinical trial. The first clinical trial will be a phase I, randomized, controlled, double-blinded, dose-escalation study to examine tolerability, dose, and immune response of a multiclade, multicomponent HIV DNA plasmid vaccine. The hypothesis is that this vaccine will be safe for human administration and elicit immune responses to HIV. Dose escalation will be initiated provided there are no significant adverse events in the previous dose level.