A Phase I Clinical Trial of an HIV-1 Multiclade Vaccine

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 begin Phase I evaluation in humans. A new Phase I clinical trial, VRC 007 (04-I-0254) was opened to accrual on 8/17/02 by the VRC Clinical Trials Core (CTC) following completion of the regulatory approvals needed from the FDA, IRB and IBC. The CTC is on track to meet the study target enrollment of 15 subjects early in FY05. The study includes administration of the vaccine at a dosage of 4 mg. The CTC will complete the required schedule of 32 weeks of follow-up visits in FY05.