Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
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United Press International - Friday, March 10, 1989
MicroGeneSys Inc. said this week that the government-approved human trials will be the first step in determining whether its vaccine-like drug can help keep the AIDS virus in check after it has infected people.
"We think this would improve the quality of life for people infected with the AIDS virus," said Franklin Volvovitz, chairman of MicroGeneSys Inc.
Volvovitz said the test will be done on people who show no symptoms but have been infected with the human immunodeficiency virus, known as HIV, which causes AIDS.
"It takes many years between infection and the onset of the disease and that is where the majority of people who have AIDS are at right now," he said.
Brad Stone, a spokesman for the Food and Drug Administration, said the trial will be the first FDA-approved tests in the effort to determine whether potential vaccines can be used to treat people already infected with the AIDS virus. Stone said vaccine pioneer Jonas Salk is trying a similar approach in trials regulated by California.
The new study, which will simply check the safety - not the effectiveness - of using the vaccine for treatment, will be carried out at the Walter Reed Army Institute of Research and the Walter Reed Army Medical Center in Washington, D.C.
Volvovitz said more than 30 HIV-positive volunteers will be recruited for the clinical test of the MicroGeneSys vaccine known as VaxSyn(R) HIV-1. He said the volunteers may be either men or women but must be judged free of AIDS symptoms.
Each volunteer will receive several intramuscular injections of the vaccine over a 12-month period. The volunteers will receive initial vaccine doses ranging from 40 to 60 micrograms and subsequent booster shots of the same dosage. Medical investigators will follow the volunteers for 15 months, Volvovitz said.
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