BUSINESS WIRE; Thursday, July 30, 1998
The North American Phase III trial got under way last month at clinics in Philadelphia and St. Louis and is projected to expand to 30 to 40 clinics and 5,000 volunteers at risk for HIV infection.
"We are eager to participate in this study because we see it as a milestone in the effort to prevent HIV infection," said Clayton Harro, M.D., Medical Director of the Johns Hopkins Center for Immunization Research and Principal Investigator of the study being conducted at D.C. General.
"AIDS is to our generation what smallpox was to previous generations," Dr. Harro continued. "And what stopped the suffering and death from that epidemic? A vaccine. This study offers the opportunity for those in the communities most affected by this epidemic -- especially gay men -- to take a leadership role in developing a preventive HIV vaccine."
Phase III studies are designed to test the vaccine's efficacy in a real-life setting. Trial participants will be selected from among volunteers who are at risk for HIV infection but who are currently uninfected. Over the course of 30 months, volunteers will be given seven injections, but neither volunteers nor researchers will know which volunteers are given the vaccine and which receive a placebo (inactive substance).
In the North American trial, the volunteers will be selected from among individuals at risk through sexual transmission -- primarily gay males and women with HIV-positive partners.
VaxGen anticipates beginning the Phase III trial of a separate formulation of AIDSVAX in Thailand later this year, following approval by the Thai Ministry of Health. That trial will involve volunteers at risk of HIV infection through injection-drug usage.
Throughout the three-year trials, volunteers will be counseled on methods to avoid HIV infection and cautioned not to construe their participation in the trial as protection against infection. Follow-up with volunteers will continue for at least six months after the last injection is administered.
At the end of the 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.
"We are pleased to have D.C. General and Johns Hopkins join the AIDSVAX study," said Dr. Donald P. Francis, President of VaxGen, "especially considering the deep ties to the community and rich history of vaccine research and development represented, respectively, by these institutions. The support of the volunteers, researchers and hospitals like D.C. General is essential to VaxGen's goal of developing a vaccine against HIV."
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. The first two volunteers in the Phase III North American trial were given injections at the Philadelphia FIGHT clinic on June 23, 1998.
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 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.
Earlier clinical trials have shown that AIDSVAX is safe for use in humans and induces a strong immune response. AIDSVAX cannot cause HIV infection or AIDS.
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/. NOTE: For information about volunteering in the D.C. study, phone (877) 243-7829.
CONTACT: Donna K.H. Walters, (Pager 888-443-0055) Anne George, (Pager: 800-686-7073) Nicole Lynch, (Pager: 800-686-7074) or Sitrick And Company (212) 755-2850 (310) 788-2850
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