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

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

BACKGROUND 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 A244ÄV1 gp160 DNA vaccine 2) HIV clade B A244ÄV1 Gag DNA vaccine 3) HIV clade A/E A244 gp120 protein deleted in V1 and engineered to maintain V2 in an á-helix conformation (A244ÄV1gp120).