WASHINGTON -- A group of AIDS doctors set a timetable yesterday for an experimental and potentially risky vaccine trial next year in which they have volunteered to serve as guinea pigs.
The federal government has not yet approved the trial.
If the trial goes ahead and there are no adverse reactions, researchers say, the vaccine could be tested in larger populations within a year or two and possibly be ready for worldwide distribution before 2007, the goal set by President Clinton for developing a vaccine for acquired immune deficiency syndrome.
A Chicago-based group, the International Association of Physicians in AIDS Care, marshaled its arguments to support the vaccine trial at the First International Conference on Healthcare Resource Allocation for HIV/AIDS and Other Life-Threatening Illnesses.
The physicians group said that reaching the 10-year goal is unlikely unless trials using the live vaccine are started soon.
The doctors have scheduled meetings with the National Institutes of Health next week to seek the agency's support for the trials.
The vaccine manufacturer, Therion Biologics of Cambridge, Mass., is scheduled to meet with the Food and Drug Administration next month to deal with objections to using the vaccine.
In an effort to break an impasse over conducting human tests with the vaccine, which is made of a live but weakened AIDS virus, the group said five physicians have agreed to be the first volunteers.
"It has been very frustrating to me that a clinical trial has not yet started," said Dr. Charles F. Farthing, medical director of the Los Angeles-based AIDS Healthcare Foundation, and a vaccine volunteer. "If it works, we will have an AIDS vaccine ready for worldwide use in 10 years."
In September, 50 doctors announced they were willing to be injected with the live vaccine to disprove the notion that healthy, educated people would not volunteer. Since then, 300 more doctors have volunteered, Farthing said.
"This should help dispel ethical concerns about informed consent," he said. "Some people were critical that we would only be able to get prisoners or uneducated people in developing countries to take part in vaccine trials."
The National Institutes of Health has balked at approving the trial because of concerns that the live vaccine could possibly cause AIDS or other diseases. The agency wants more research.
The physicians group said the AIDS epidemic is out of control around the world and that desperate measures are needed. A vaccine offers the only hope of stopping the spread of the deadly virus, which is transmitted primarily through heterosexual activities in most parts of the world, the physicians said.
Each day 8,500 adults and 1,000 children are infected with the AIDS virus throughout the world. Thirty million people have already been infected, and it is estimated that in 10 years that number could reach 70 million to 100 million.
Clinton, in a message sent to conference participants, said the development of an effective vaccine is vital in view of the spread of the AIDS virus.
The risks associated with the live vaccine are minimal, especially especially compared to the potential benefits of an AIDS vaccine in preventing millions of deaths, Farthing said.
Pub Date: 11/12/97