The first clinical trial in the Bay Area to test the effectiveness of an AIDS vaccine was launched this week through a joint project of the San Francisco Department of Public Health and the University of California San Francisco. Known as a Phase III trial, the DPH/UCSF study will focus on the ability of the test vaccine to protect the body against HIV infection. It is part of a three-year, multi-site clinical research effort that is the first in the U.S. to look specifically at this aspect of a test vaccine.
The test vaccine is produced through genetic engineering techniques, so it is a synthetic product and does not contain any live virus. It cannot cause HIV infection.
The test vaccine product, named AIDSVAX, was developed by VaxGen, a biotech company based in Brisbane, Calif. The overall trial is being carried out at more than 50 locations throughout North America with the goal of enrolling 5,000 participants.
The DPH/UCSF team hopes to enroll 300 study volunteers. Study co-directors are Susan Buchbinder, M.D., chief of the HIV Research Section at DPH, and James Kahn, M.D., associate professor in the UCSF Positive Health Program at San Francisco General Hospital Medical Center.
The test vaccine is designed to train the immune system to develop a defense mechanism against the outer covering of HIV so the virus fails to spread throughout the body. It is not known if this approach will be effective in protecting the body against infection. Learning the answer is the overall objective of the Phase III trial.
In order to take part, volunteers must be adults who currently are HIV-negative and at risk for HIV infection through sexual exposure. All volunteers will receive extensive counseling that will focus on reducing the chance of becoming exposed to HIV.
The trial is a "double-blind" study with some participants receiving the test
vaccine and some participants receiving a placebo, an inactive substance used as
a comparison. N
Contact: Corinna Kaarlela
University of California - San Francisco