Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Friday October 16, 1998
"The study will provide important new information about which vaccine-induced immune responses can protect against HIV," said Frank Rhame, M.D., an infectious disease specialist at Abbott Northwestern and the study's principle investigator.
During the trial, neither volunteers nor researchers will know which volunteers are given the vaccine and which receive a placebo (inactive substance). Volunteers will be those who are at risk for HIV infection through sexual transmission but who are currently uninfected.
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. The comparison will be used to determine the efficacy of the vaccine.
On June 3, 1998, VaxGen, the developer of AIDSVAX, received FDA clearance to begin the U.S. portion of Phase III clinical trials of AIDSVAX. The first two volunteers in the Phase III North American trial were given injections in Philadelphia on June 23, 1998.
AIDSVAX is created from recombinant copies of the glycoprotein (rgp 120) from two types of HIV. Injecting rgp 120 into the body stimulates the production of antibodies that, in any future exposure to HIV, would hopefully prevent infection.
The vaccine 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.
Earlier clinical trials have shown that AIDSVAX is safe for use in humans and induces a strong immune response.
Abbott Northwestern Hospital is a part of Minneapolis-based Allina Health System, an integrated health care system comprised of doctors, hospitals and health plans serving communities throughout Minnesota, western Wisconsin and eastern North and South Dakota. Allina's vision is to be the recognized innovator in improving the health of the communities it serves.
Allina is a not-for-profit health care system formed in July 1994 by the merger of HealthSpan, a health care delivery system, and Medica, a health plan organization.
SOURCE: Allina Health System
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