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 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. The proposed protocol design is to enroll subjects who will be randomly assigned to vaccine or PBS control injections. If there are no significant toxicities, dose escalation will be initiated.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Intramural Research (Z01)
Project #
1Z01AI005041-03
Application #
6987348
Study Section
(VPP)
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2004
Total Cost
Indirect Cost

  Institution

Name
Niaid Extramural Activities
Department
Type
DUNS #
City
State
Country
United States
Zip Code

  Publications

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
Sheets, R L (2006) Adventitious agent test methods. Dev Biol (Basel) 123:135-45; discussion 183-97
Sheets, Rebecca (2006) Assaying potency of novel vaccines. October 11-12, 2005, Bethesda, MD, USA. Expert Rev Vaccines 5:315-8
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