BUSINESS WIRE; Tuesday September 15, 1998
The North American Phase III trial got under way in June in Philadelphia and since then, clinics in St. Louis, Washington D.C., Denver, New Orleans and West Hollywood have been accepting volunteers. The trial is projected to expand to 30 to 40 clinics and 5,000 volunteers at risk for HIV infection.
"We are proud to be participating in this study because we are committed to the effort to prevent HIV infection," said Dr. Harold Kessler, Principal Investigator, CCCR, "While we must, as a society, continue to explore treatments for those already infected and those suffering from AIDS, we know the only way to end this epidemic is to prevent new infections with a vaccine."
AIDSVAX has already been given to more than 1,200 individuals in earlier-stage trials. In June, the U.S. Food and Drug Administration cleared VaxGen to proceed with Phase III trials, which are designed to test the vaccine's efficacy.
"We are pleased to have the Chicago clinic join the AIDSVAX study," said Dr. Donald P. Francis, President of VaxGen. "This community has been deeply affected by and involved with the AIDS crisis and this clinic is showing its continuing commitment to preventative research. The support of the volunteers, researchers and clinics is essential to VaxGen's goal of developing a vaccine against HIV."
Trial participants are 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 an inactive placebo.
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 2,500 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.
Phase III trials are a critical step in the strictly regulated and monitored process by which a new vaccine or drug is tested and precede application to the FDA to license and market the product.
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 and the Pacific Rim.
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. On August 18, VaxGen and the National Institute of Allergy and Infectious Diseases, an agency within the National Institutes of Health, announced that NIAID will collaborate in research in conjunction with the Phase III trials of AIDSVAX.
VaxGen, based in South San Francisco, CA, is a biotechnology company committed to making an HIV vaccine for worldwide use.
Founded in 1987, CCCR is a nationally recognized research center which conducts investigational studies. Like medical centers, research institutes and medical schools around the country, CCCR works with pharmaceutical companies in testing new medications. Currently, CCCR is involved in several additional studies for new therapies to treat high cholesterol, high blood pressure, arthritis, diabetes, women's health and many more. For more information or to volunteer call 1-800-494-2227.
Complete background information is available on our website at: http://www.vaxgen.com/.
Contact: Michael Kritschgau, 312/494-2233 or Sitrick And Company, Los Angeles Nicole Lynch, 310/788-2850 800/686-7074, pager
980904
BW980904
Copyright © 1998 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1998. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .