A Phase I Clinical Trial of a Multiclade HIV-1 DNA Plasm

Niaid Extramural Activities

Investigators

Abstract

The clinical aspect of this project follows the vaccine production and preclinical safety and immunogenicity testing needed to allow an investigational HIV vaccine to into Phase I evaluation in humans. A new Phase I clinical trial, VRC 004 (03-I-0022) was opened to accrual on 11/13/02 by the VRC Clinical Trials Core (CTC) following completion of the regulatory approvals needed from the FDA and IRB. The CTC enrolled all 50 subjects by 8/13/03 to meet the study target enrollment. The study has included administration of vaccine dosages of 2 mg, 4 mg or 8 mg of the investigational vaccine. The CTC is completing the required schedule of follow-up visits needed, which will continue through 8/13/04.