University of Rochester Medical Center to Begin Enrollment in Phase III Trials of AIDSVAX Vaccine
November 10, 1998
The University of Rochester Medical Center will begin enrolling volunteers tomorrow in a trial of AIDSVAX, the first-ever preventative vaccine against HIV infection to be tested in large scale efficacy (Phase III) human studies. The trial, which will enroll 5,000 volunteers at risk for HIV infection, is sponsored by VaxGen, Inc., the developer of AIDSVAX. The University of Rochester is the first site in Upstate New York to participate.
The University of Rochester Medical Center’s Infectious Diseases Unit has played a prominent role in vaccine research and development for over two decades, and is one of the original AIDS Vaccine Evaluation Units sponsored by the National Institutes of Health (NIH), having enrolled over 500 volunteers to-date in the early Phase I and Phase II trials.
"The AIDS Vaccine Evaluation Unit has been conducting Phase I and Phase II trials of AIDS vaccines since 1988," said Thomas Evans, M.D., principal investigator of the study. "I am excited that we have finally arrived at the day when we can take this next important step in stopping this epidemic. This study is important in that it offers HIV-negative women and men an opportunity to play a role in this effort. It is inspiring to see the altruism demonstrated by volunteers in studies like this."
In the North American trial, the volunteers will be those individuals who are uninfected, but at risk of HIV infection through sexual transmission -- both men who have sex with men and women who have sex with HIV-positive men.
During the trial, neither the volunteer nor the researcher will be aware of which volunteers are given the vaccine and which receive a placebo. Each volunteer will be given a total of seven inoculations during a 30-month period. Follow-up will continue for at least six months after the last inoculation is administered. During participation in the study, volunteers will receive counseling on methods of avoiding HIV infection. Volunteers will be told not to expect protection from the disease as a result of their participation in the study.
At the end of the three-year trial, the rate of infection in the group that received the placebo will be compared to the rate of infection among volunteers who received the vaccine. The comparison will be used to determine the effectiveness of the vaccine.
Earlier clinical trials have shown that AIDSVAX is safe for use in humans and induces a strong immune response. Volunteers cannot become infected with HIV by receiving this vaccine.
Each AIDSVAX formulation is bivalent -- that is, created from man-made copies of the gp120 protein from the surface of two types of HIV. The vaccine to be tested in Rochester and other sites across North America is designed to protect against the major types of HIV-1 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 type of virus typical in Southeast Asia.
On June 3, 1998, VaxGen announced that it had received clearance from the U.S. Food and Drug Administration (FDA) to begin the U.S. portion of the 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 volunteers in the Phase III North American trial were enrolled in Philadelphia on June 23.
VaxGen, based in Brisbane, CA, is a biotechnology company committed to making an HIV vaccine for world-wide use. The company 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. The Thai trial will involve volunteers at risk of HIV infection through injection-drug use.
The University of Rochester will enroll volunteers at the Medical Center and at Community Health Network. The Erie County Medical Center in Buffalo, NY, which is also participating in the trial, will open for enrollment in the near future.
For more information or to participate in this study, please call (716) 273-AIDS (2437).