BUSINESS WIRE; Wednesday, July 8, 1998
The North American trial, which eventually will include 5,000 volunteers at risk for HIV infection, is sponsored by VaxGen Inc., the developer of AIDSVAX.
The Phase III trial got under way last month in Philadelphia, where the first volunteers were inoculated at the Philadelphia FIGHT clinic. Clinics in Baltimore, Chicago, Denver and Los Angeles are also 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.
"The study will provide important new information about which vaccine-induced immune responses can protect against HIV," said Geoffrey J. Gorse, M.D., professor of internal medicine in the Division of Infectious Diseases and Immunology at St. Louis University. Dr. Gorse will be the principal investigator of the AIDSVAX study in St. Louis.
During the trials, neither volunteers nor researchers will know which volunteers are given the vaccine and which receive a placebo (inactive substance).
The trials will use volunteers who are at risk for HIV infection but who are currently uninfected. In the North American trial, the volunteers will be those individuals at risk through sexual transmission -- primarily gay males and individuals 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.
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.
"St. Louis University Hospital is an important center for vaccine research and we are pleased to have them join the AIDSVAX study," said Dr. Donald P. Francis, president of VaxGen. "The support of the volunteers, clinics and hospitals like St. Louis is essential to VaxGen's goal of developing a vaccine that will end the AIDS epidemic."
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 trails 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 in Philadelphia 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 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.
Earlier clinical trials have shown that AIDSVAX is safe for use in humans and induces a strong immune response.
VaxGen, based in South San Francisco, is a biotechnology company committed to making an HIV vaccine for worldwide use.
NOTE: Additional information is available on the company's Web site at: http://www.vaxgen.com/
--30--MCB/la* TJJ/la
CONTACT: Sitrick and Co., Los Angeles 310/788-2850 212/755-2850 Donna K.H. Walters, 888/443-0055 (pager) Nicole Lynch, 800/686-7074 (pager)
980708
BW980707
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. .