>Vical DNA Vaccine Technology Enters Phase 2 Clinical Trial For HIV<
This is primarily an NIH initiative that is contracting Vical and Genvec for the developed vaccine. I do think it is rather exciting because it is a completely novel vaccination approach. Genvec's PR has some more colour, although not much since the NIH is taking the lead in this program. But for a government program, I think it is moving through development rather efficiently.
Vaccine Research Center (VRC) Initiates Phase II Testing of an HIV Vaccine Developed in Collaboration with GenVec Tuesday October 11, 11:00 am ET
GAITHERSBURG, Md.--(BUSINESS WIRE)--Oct. 11, 2005--GenVec, Inc. (Nasdaq:GNVC - News) announced today that the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, has begun Phase II clinical testing of an experimental adenovector-based HIV vaccine candidate developed in collaboration between GenVec and the VRC.
The double-blind, placebo-controlled Phase II study will enroll a total of 480 healthy volunteers who will be randomized 1:1 to receive either vaccine or placebo. The treatment group will receive a DNA plasmid injection (the "prime") followed by the adenovector-based booster vaccine. Both vaccines contain DNA segments from the three major HIV subtypes, or "clades," responsible for approximately 85 percent of HIV infections worldwide. The placebo group will receive saline injections. The trial is anticipated to include volunteers in the U.S., Haiti, Brazil, Trinidad, South Africa and Botswana.
GenVec produced the adenovector vaccine under a $50 million subcontract that extends through 2008. This subcontract was funded by the VRC, and issued and managed by SAIC-Frederick under an NCI contract. Clinical testing is being conducted under the auspices of NIAID and its clinical trial networks.
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