Multicomponent HIV-1 Recombinant Adenoviral Vector Vacci

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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 phase I, randomized, placebo-controlled, dose-escalation study of a multicomponent HIV-1 adenoviral vector vaccine. The hypothesis is that the vaccine will be safe for human administration and elicit immune responses to HIV-1. The proposed protocol design is to enroll subjects who will be randomly assigned to vaccine or PBS control injections. If there are no significant toxicities, dose escalation will be initiated.