The sites are part of the HIV Vaccine Trials Network (HVTN), which is headquartered at Fred Hutchinson Cancer Research Center in Seattle and supported through a cooperative agreement with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. The trial sites also receive funding from the South African AIDS Vaccine Initiative.
"This trial will answer several major scientific issues that face all of us in the field of HIV-vaccine development," said Lawrence Corey, M.D., principal investigator of the HVTN and a member of the Hutchinson Center's Clinical Research Division. "It will determine the usefulness of vaccines that induce high immune response to the parts of the virus that are similar between different strains of HIV-1."
The study is known as a phase IIb or "test of concept" efficacy trial because it enables researchers to determine whether the test vaccine prevents HIV infection, results in lower HIV levels in those who become infected after vaccination or both. In addition, investigators for the South Africa vaccine trial will determine if this vaccine, which is based on clade B HIV, has the potential to protect against the clade C virus, the subtype prevalent in South Africa. Phase IIb trials cannot be used to support licensure of a vaccine, however, the data from this study will guide whether this type of vaccine approach offers promise to interrupt the continued spread of HIV.
Additionally, the South African study is likely to provide important new data on how the test vaccine might work in a predominantly heterosexual HIV epidemic, how well the vaccine works in women, and
Source:Fred Hutchinson Cancer Research Center