Development And Production Of A Multiclade Hiv-1 Dna Pla

Gomez, Phillip L.

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.

Funding Agency

• Agency: National Institute of Health (NIH)
• Institute: National Institute of Allergy and Infectious Diseases (NIAID)
• Type: Intramural Research (Z01)
• Project #: 1Z01AI005040-02
• Application #: 6822452
• Study Section: (VPP)
• Support Year: 2
• Fiscal Year: 2003

Institution

• Name: Niaid Extramural Activities
• Country: United States

Publications

Catanzaro, Andrew T; Roederer, Mario; Koup, Richard A et al. (2007) Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine. Vaccine 25:4085-92

Tavel, Jorge A; Martin, Julie E; Kelly, Grace G et al. (2007) Safety and immunogenicity of a Gag-Pol candidate HIV-1 DNA vaccine administered by a needle-free device in HIV-1-seronegative subjects. J Acquir Immune Defic Syndr 44:601-5

Sheets, Rebecca L; Stein, Judith; Manetz, T Scott et al. (2006) Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts. Toxicol Sci 91:620-30

Sheets, Rebecca L; Stein, Judith; Manetz, T Scott et al. (2006) Biodistribution of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar, without integration, despite differing plasmid backbones or gene inserts. Toxicol Sci 91:610-9

Graham, Barney S; Koup, Richard A; Roederer, Mario et al. (2006) Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis 194:1650-60