NIH begins Phase 1 clinical trial of HIV vaccine candidate

GenVec announced today that the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has begun the second Phase 1 clinical trial in healthy adult volunteers of an HIV vaccine candidate 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.

GenVec produced the adenovector- based vaccine under a $40 million subcontract issued and managed by SAIC- Frederick that extends through 2008. The candidate vaccine is currently being evaluated by the VRC in conjunction with the Division of AIDS/NIAID and its HIV Vaccine Trials Network (HVTN).

This second Phase 1 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. The recombinant adenovector contains several parts of the HIV genome, but is not replication-competent and cannot result in HIV infection.

Results from the study will be used to evaluate safety and whether this approach can improve the body's immune responses against HIV versus responses that are induced by the HIV DNA vaccine candidate alone or the HIV adenovector alone. Enrollment in the first VRC Phase 1 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.

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