NIH BEGINS SECOND PHASE I TRIAL OF HIV VACCINE

GenVec has announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, has begun the second Phase I clinical trial in healthy adult volunteers of an HIV vaccine candidate.

The vaccine is being jointly developed by the Dale and Betty Bumpers Vaccine Research Center (VRC), a part of NIAID, and GenVec.

The vaccine was developed using GenVec's proprietary adenovector technology and the company's 293-ORF6 production cell line. The study vaccine is directed against the three major strains of HIV that cause AIDS worldwide and is currently being evaluated by the VRC in conjunction with the Division of AIDS/NIAID and its HIV Vaccine Trials Network.

This second Phase I trial will preliminarily assess whether administration of the adenovector-based vaccine is safe and well-tolerated in volunteers previously immunized with an HIV DNA vaccine candidate invented by the VRC. Approximately 60 healthy, HIV-negative volunteers will receive an adenovector-based HIV booster shot between six and nine months after receiving the initial HIV DNA vaccination; 10 additional HIV-negative volunteers will receive placebo.

Enrollment in the first VRC Phase I trial is now complete. That study involved a single administration of an adenovector-based HIV vaccine candidate that was produced by GenVec and given to healthy adult volunteers to test for safety and tolerability of various doses of the candidate and indications of immune response against the HIV virus.