Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Bay Windows - Local News January 12,1999
Scott A. Giordano,Bay Windows staff
Boston residents Michael Chick and Carl Wallace received inoculations at the FCHC prior to a press conference announcing the arrival of the first-ever Phase III clinical trial of a preventive AIDS vaccine, which in this study is AIDSVAX.
"I am proud to be a part of this historic study that will have a far-reaching impact," Chick said at the press conference, whose comments were echoed by Wallace.
"I decided to do this because if I can't do it myself, then I can't ask someone else to do this for me," Wallace said.
VaxGen, Inc. - the developer of AIDSVAX - received clearance from the U.S. Food and Drug Administration (FDA) in June to begin the trial, which ultimately will include 5,000 volunteers from about 40 clinical sites nationwide. The FCHC is the first New England site to be involved with the study, which began in Philadelphia. The clinical trials at the FCHC are being conducted under its Project ACHIEVE (AIDS Community Health Initiative Enroute to a Vaccine Effort) program - in collaboration with the Miriam Hospital in Providence, R.I., and the Memorial Hospital in Pawtucket, R.I.
"The [FCHC] was one of the first sites to describe the extent of the HIV epidemic in New England. ... This is as far as we have gotten as far as the biological means of preventing HIV infection," said FCHC Medical Research Director Dr. Kenneth Mayer, who is also the director of the Brown University AIDS Program. "We have been preparing this community for a trial like this since 1994. I am excited that we have finally arrived at the day when we can take this next, important step in ending [the AIDS] epidemic."
The study uses HIV-negative individuals who are considered to be at high risk for the disease, including men who have sex with men and women who have sex with HIV-positive men. The individuals are encouraged to continue taking precautionary methods to protect themselves from HIV while participating in the clinical trials. Medical specialists say it's not possible for the volunteers to acquire HIV from the vaccinations.
During the trials, neither volunteers nor researchers will know which volunteers are given the AIDSVAX vaccine and which ones are given a placebo, or inactive substance. Each volunteer will receive seven inoculations during a 30-month period. At the end of the trial, which is expected to last three years, the HIV infection rate in the group that received the vaccination will be compared with the infection rate in the group that received the placebo - with that comparison being used to determine the effectiveness of the vaccine.
John Auerbach, executive director of the Boston Public Health Commission, said the study is significant because many HIV-negative individuals are still "engaging in high-risk behaviors that place them at risk for HIV."
The study isn't seeking to find a cure for AIDS, but rather to find a vaccine that can prevent people from being infected with the strain of HIV known as HIV1, which is the most common one in the United States that eventually leads to AIDS.
(For more information about the Fenway's HIV vaccination trial call 617-927-6450, or e-mail vaccine@fchc.org.) t
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