CGMP MANUFACTURE OF TWO HIV DNA VACCINES AND ONE HIV PROTEIN VACCINE COMPONENT

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This request to Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) for the cGMP manufacture of HIV-based DNA and protein vaccine components. These clinical products will be used to test the immunogenicity and safety of HIV vaccine candidates in a phase I clinical trial. These immunogens, never tested in humans, include novel HIV gp160 envelope immunogens engineered to minimize antibody interference in a vaccine platform that elicits long lasting monocytes memory responses to HIV. Specifically, we are requesting the cGMP production of: 1) HIV clade A/E A244∆V1 gp160 DNA vaccine 2) HIV clade B A244∆V1 Gag DNA vaccine 3) HIV clade A/E A244 gp120 protein deleted in V1 and engineered to maintain V2 in an α-helix conformation (A244∆V1gp120).