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At least 10 healthy people will test a vaccine that may combat the virus' wily nature.
By WES ALLISON, Times Staff Writer
© St. Petersburg Times, published May 14, 2002
TAMPA -- Researchers from the University of South Florida are seeking volunteers to test a promising new AIDS vaccine that has been proved to slow the disease in monkeys.
Although it likely will be five to seven years before the vaccine becomes part of the AIDS arsenal, if ever, the small study at USF and Tampa General Hospital is a crucial step in finding a drug that will either prevent infection or slow the disease in people who are already sick.
TGH is one of 16 research centers nationally that's participating in the trial, which is funded by the vaccine's developer, Merck & Co. The Tampa researchers are seeking at least 10 healthy volunteers.
"This is really a very, very critical study not only for the drug company, and the business of HIV, but the (Food and Drug Administration) in deciding if this is the candidate to go forward with," said Dr. Jeffrey Nadler, director of clinical research in infectious diseases at USF and TGH.
The hunt for an AIDS vaccine has been largely thwarted by the wily nature of the disease. Traditionally, vaccines, such as the polio vaccine, work by encouraging the body to develop antibodies to prevent infection.
But HIV gets around such antibodies by changing itself slightly.
The new vaccine, like the vaccine for chicken pox, works differently: Instead of building antibodies, it teaches killer cells in the immune system, called lymphocytes, to hunt down and kill cells that contain HIV.
"We're looking for very specific responses that are directed at the HIV itself, not at the up-regulation of the immune system," as other vaccines often work, Nadler said.
In February, Merck announced that the vaccine sharply slowed the reproduction of the AIDS virus in Rhesus monkeys that had the disease. Small numbers of healthy people also have been given components of the vaccine separately to study their safety.
In those studies, the drug appeared safe and seemed to create the same immune response in humans as was seen in monkeys.
The 10 or so people who enroll in the USF/TGH study will be among the first to get all three major components of the vaccine, which should be close to the finished product, Nadler says. About 120 volunteers are being sought nationwide.
If the study proves successful, Merck will begin testing the vaccine in people who are at high risk of developing HIV or who have it.
The vaccine is created from synthetic versions of select HIV genes. It cannot cause HIV, but those who take it can wrongly test positive for HIV in the short term.
It carries other risks, but they are more remote, Nadler said.
Anyone wishing to apply to enroll is asked to call the TGH Clinical Research Center at (813) 844-7829.