Production And Evaluation Of An HIV-1 DNA Vaccine

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 Phase I, randomized, placebo-controlled, dose-escalation study. The IND was approved in May 2001 (BB-IND 9782). This is a Phase I randomized, controlled, double-blinded dose escalation study to examine toxicity, dose and immune response of an HIV plasmid DNA vaccine. The vector used in this study has been optimized for improved safety, expression and immunogenicity. We hypothesize that this vaccine will be safe and elicit immune responses to HIV. Enrollment was completed 2Q03, follow up was completed a year later and final immunological analysis will be completed 3Q04.