The IND was approved in May 2001 (BBIND9782). This is a Phase I randomized, controlled, double-blinded dose escalation study to examine toxicity, dose and immune response of an HIV plasmid DNA vaccine. The vector used in this study has been optimized for improved safety, expression and immunogenicity. We hypothesize that this vaccine will be safe and elicit immune responses to HIV. There will be 3 groups of 7 volunteers. Each group will receive a constant dose of the vaccine pGag(del fs)Pol del PR del RT del IN/h (5 people) or a phosphate buffered saline (PBS) control (2 people) by intramuscular inoculation. Once safety has been established, successive groups will receive a higher dose. Study groups will receive three immunizations containing either 0.5 mg (Group 1), 1.5 mg (Group 2), or 4.0 mg (Group 3) of a DNA vaccine. Dose escalation will be initiated 5 weeks after the last volunteer in the previous dose group receives their first inoculation, providing there are no significant toxicities.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Intramural Research (Z01)
Project #
1Z01AI005042-01
Application #
6696473
Study Section
(VPP)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2002
Total Cost
Indirect Cost
Name
Niaid Extramural Activities
Department
Type
DUNS #
City
State
Country
United States
Zip Code