BUSINESS WIRE; Tuesday June 23, 8:58 am EST
Clinics in Baltimore, Chicago, Denver, Los Angeles and St. Louis are expected to begin AIDSVAX vaccinations in coming weeks, and several other clinical trial sites are in the process of finalizing plans to join the trial, which will encompass 30 to 40 sites throughout North America.
"We are delighted to be the clinic that begins this significant trial of AIDSVAX," said Dr. Jay R. Kostman, MD, Medical Director of Philadelphia FIGHT. Dr. Kostman, who also is an Associate Professor of Infectious Diseases at Temple University, will be Principal Investigator of the AIDSVAX study at Philadelphia FIGHT. A community-oriented medical research organization formed in 1990, Philadelphia FIGHT conducts clinical trials related to HIV and AIDS and provides a wide range of services to individuals already infected by HIV or living with AIDS.
Dr. Kostman said: "While we at Philadelphia FIGHT remain committed to improving treatment options for those already infected with HIV, we look forward to a day when a universal vaccine will stop the spread of the virus. The beginning of this test today is an important step toward reaching that goal."
During the trials, neither volunteers nor researchers will know which volunteers are given the vaccine and which receive a placebo (inactive substance). The trial will use volunteers who are at high-risk for HIV infection but who are currently uninfected. In the North American trials, the volunteers will be those individuals at risk through sexual transmission -- primarily gay males and individuals with HIV-positive partners.
Each volunteer will be given a total of seven inoculations during a 30-month period. Follow-up with volunteers will continue for at least six months after the last inoculation is administered. At the same time, volunteers will be counseled on methods to avoid HIV infection and to not depend upon the experimental vaccine to provide protection from infection.
At the end of the three-year trial, the rate of infections in the group that received the placebo will be compared to the rate of infections, if any, among volunteers who received the vaccine. That comparison will be used to determine the efficacy of the vaccine.
On June 3, 1998, VaxGen announced that it had received clearance from the U.S. Food and Drug Administration to begin the U.S. portion of Phase III clinical trials of AIDSVAX. Phase III trials are a critical step in the strictly regulated and monitored process by which a new vaccine or drug is tested and precedes application to the FDA to license and market the product. Earlier clinical trials have shown that AIDSVAX is safe for use in humans and induces a strong immune response.
"We are grateful for the overwhelming response and support we have received since announcing the trial," said Dr. Donald P. Francis, president of VaxGen. "The support of the volunteers and clinics like Philadelphia FIGHT is essential to VaxGen's goal of developing a vaccine that will end the AIDS epidemic." The company also anticipates beginning Phase III trial of a separate formulation of AIDSVAX in Thailand later this year, following approval by the Thai Ministry of Health.
Each AIDSVAX formulation is bivalent -- that is, created from recombinant copies of the gp120 protein from the surface of two types of HIV. The vaccine to be used in Philadelphia and other test sites across North America is formulated to protect against infection by the major types of HIV-1 virus most typical of infections in the Americas, Western Europe and Australia. The formulation of the vaccine to be used in the Thai trial is designed to protect against the major types of the virus typical of infections in Southeast Asia.
Recently published studies have elaborated on the importance of the role of gp120 in HIV infections, confirming extensive testing and studies by VaxGen and earlier by Genentech, Inc., which began research on AIDSVAX 14 years ago. In the most recent issues of Science and Nature, researchers at Columbia University and the Dana-Farber Cancer Institute in Boston reported that a powerful use of X-rays, called crystallography, showed that HIV uses gp120 surface protein in a two-pronged attack to attach to and infect healthy T-cells.
"AIDSVAX was specifically designed to address this two-pronged strategy of the virus," said Dr. Phillip W. Berman, VaxGen's chief scientist and Vice President of Research. "Our vaccine induces several different antibodies, any one of which can neutralize HIV. The antibodies hit on the same locations of gp120 shown by the crystallography studies to be the sites responsible for infection, and neutralize forms of HIV which attack both T-cells and macrophages. We are excited to see that the data from this study validate our approach."
VaxGen, based in South San Francisco, Ca., is a biotechnology company committed to making an HIV vaccine for worldwide use.
Additional information is available on our web site at: http://www.vaxgen.com/
Contact: Sitrick And Company Donna K.H. Walters Anne George Steve Hawkins (310) 788-2850 (212) 755-2850
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