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 2 mg, 4 mg or 8 mg doses of the investigational vaccine. During FY04 the CTC completed the required schedule of 52 weeks of clinical follow-up visits.
