This project is designed to prepare a GMP quality investigational HIV vaccine and complete the preclinical and laboratory studies needed for clinical studies 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. Subjects receive adenovector vaccine either as a single agent or as a boost after priming with plasmid DNA vaccines. The Vaccine Research Center (VRC), NIAID is developing a novel prime-boost HIV vaccine strategy directed at the three most globally prevalent HIV subtypes (clades). VRC's HIV prime-boost candidate is designed to elicit immune responses to HIV sequences from clades A, B and C which together cause about 90 percent of incident HIV infections around the world. In November 2004, the VRC Clinical Trials Core launched a Phase I clinical study (VRC 006) of a multiclade, multigene recombinant adenovector 5 vaccine at the NIH Clinical Center (Bethesda, MD) as the first step in developing the prime-boost regimen. This product has since been evaluated clinically as a single agent and as part of a DNA prime-adenovector boost regimen in several Phase 1 and 2 clinical trials in U.S. and international sites. Production of Phase II materials has been completed.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Intramural Research (Z01)
Project #
1Z01AI005041-07
Application #
7732757
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
7
Fiscal Year
2008
Total Cost
$1,938,372
Indirect Cost
City
State
Country
United States
Zip Code
Cheng, Cheng; Gall, Jason G D; Kong, Wing-pui et al. (2007) Mechanism of ad5 vaccine immunity and toxicity: fiber shaft targeting of dendritic cells. PLoS Pathog 3:e25
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Butman, B T; Lizonova, A; Brough, D E et al. (2006) Comprehensive characterization of the 293-ORF6 cell line. Dev Biol (Basel) 123:225-33; discussion 265-6