Chicago Tribune (CT) - WEDNESDAY, November 12, 1997 Edition: NORTH SPORTS FINAL Section: NEWS Page: 3 Word Count: 919
Ronald Kotulak, Tribune Staff Writer.

The federal government has not yet approved the trial. If it 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 an AIDS vaccine.

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 next week with the National Institutes of Health to seek the agency's support for starting 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 controversial 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 frustating 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 running 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 in the world, 8,500 adults and 1,000 children are infected with the AIDS virus.

Thirty million people have 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.

Although new drug treatments have led to a 23 percent decline in AIDS deaths in the U.S. in 1996, some minority and ethnic groups have not benefited from these improvements, he said.

The risks associated with the live vaccine are minimal, especially compared with the potential benefits of an AIDS vaccine in preventing millions of deaths, Farthing said.

Besides the live vaccine, seven other AIDS vaccines have been developed, but they are not made up of the live virus. Instead, they are made up of harmless components of the virus.

Vaccines work by stimulating the body's natural defenses to build an immunological response to a potentially harmful germ.

So far, none of the AIDS vaccines made of viral parts have been strong enough to stimulate significant immunity to the virus in preliminary human trials.

None are being tested in larger groups of people.

The strongest type of immune response is produced by vaccines made up of live viruses that have been genetically weakened so that they cannot cause disease.

Because the AIDS virus behaves so differently than other viruses and it is so deadly, many scientists insist on more research to show that a live vaccine is safe.

The live virus is made by clipping off four of the virus' nine genes. The idea is to have the virus stimulate a strong immune-system response, yet be incapable of causing AIDS.

Evidence that the clipped virus might not cause disease has come from Australia. Nine people who were infected with a naturally mutated AIDS virus through blood transfusions have not become sick years after exposure. This virus was missing only one gene.

In addition, chimps immunized with the live-virus vaccine developed an immune response, Farthing said. Although chimps generally don't develop AIDS, the experiment shows that the vaccine can provoke an immunological response, he said.

In one experiment, however, newborn chimps injected with the live vaccine developed AIDS symptoms, Farthing said.

Dr. Richard Marlink, executive director of the Harvard AIDS Institute, said that virologists from around the world agree that some of the AIDS vaccines should undergo widespread human trials because that is the only way to determine if any of them will work.

Half the vaccines in use to fight diseases had no clear indication that they would work in people based on preliminary research, he said. They did provide immunity in large-scale human trials, he said.

Scientists still don't fully understand how some vaccines, such as the polio vaccine, work, yet that has not prevented their use, he added.

Copyright 1997/The Chicago Tribune. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Chicago Tribune, 435 North Michigan Avenue, Chicago, IL 60611.
971112
CT971102

Always watch for outdated information. This article first appeared in 1997. 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, 1997. 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. .