The double-blind, placebo-controlled phase II study will enroll a total of 480 healthy volunteers, who will be randomized to receive either vaccine or placebo. The treatment group will receive a DNA plasmid injection (the “prime”) followed by the investigational adenovector-based booster vaccine.
Both vaccines contain DNA segments from the three major HIV subtypes, or “clades,” responsible for approximately 85% of HIV infections worldwide. The placebo group will receive saline injections.
The trial is anticipated to include volunteers in the US, 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 Vaccine Research Center, and issued and managed by SAIC-Frederick under an National Cancer Institute contract. Clinical testing is being conducted under the auspices of the National Institute of Allergy and Infectious Diseases and its clinical trial networks.