Miami Herald (MH) - Thursday, June 13, 1991
Gregory Spears and Tom Webb; Herald Washington Bureau

However, the U.S. Army researchers who conducted the study caution that the promising results are extremely preliminary and it will take at least another year of testing on hundreds more people to discover if the results are an aberration. The findings were called "interesting and potentially important" by Dr. Anthony M. Fauci, director of the AIDS effort at National Institute of Health, in an editorial accompanying the Journal article, which called for further clinical trials.

If further tests now under way demonstrate the long-term benefit of the AIDS vaccine treatment -- an approach first suggested in 1987 by polio vaccine inventor Dr. Jonas Salk -- it would offer new hope for more than one million Americans estimated to be infected by the fatal disease.

Unlike the polio vaccine, this would not prevent the disease, but it raises the hope of stopping the disease's progress in those already infected.

AIDS activists and researchers expressed concern that the results from the test on only 30 patients could raise false hope.

"It's an early trial, therefore people shouldn't jump to conclusions," said Jeffrey Levi, director of government affairs at the AIDS Action Council here. "It looks very promising, (but) it's been put in very few people."

The lead author of the report, Dr. Robert R. Redfield of the Walter Reed Army Institute of Research in Washington, chose not to attend a news conference announcing the results Wednesday. A spokesman said he was concerned that the study's results would be exaggerated in news coverage.

"There are many, many more questions than answers," said Paul Klein, a spokesman for Redfield at the Walter Reed Army Institute of Research, where the study was conducted. "Dr. Redfield and his colleagues insist it is not a big story."

This first phase of the clinical trial was not designed to measure the vaccine's effectiveness, but only to make sure it would do no harm to patients, said Col. Donald Burke, a U.S. Army doctor who is the senior author of the research.

Phase two studies, which began in December, will be more complex, including administering placebos to a group of HIV positive patients instead of the vaccine, Burke said.

The phase one test involved 30 HIV-infected volunteers injected with the genetically engineered vaccine called rgp 160 and developed by MicroGeneSys Inc., a Meriden, Conn., company. Of the 30 volunteers, 19 suffered no loss of disease-fighting white blood cells over 10 months. The immune systems of the 11 other volunteers continued to deteriorate, the study showed.

However -- and most promising -- nearly 90 percent of the volunteers who received the most frequent injections experienced no loss of white blood cells. Half of the volunteers received three shots, and the others received six shots.

None of the volunteers showed serious side effects from the vaccine. The vaccine appeared to be most effective on patients in the early stages of infection -- those with T-cell counts over 600 per milliliter of blood. No treatment is yet approved for those patients. The powerful anti-viral drug AZT is recommended only for people whose T-cell counts have fallen below 500.

While scientists say it's not entirely clear how the vaccine works, they believe it produced new virus-fighting antibodies that are not typically stimulated by HIV infection.

Even if the vaccine were effective in halting the destruction of white blood cells, it will take many months, even years, to demonstrate whether patients actually live longer, researchers say.

There are 140 people currently enrolled in the phase two study, but more patients will be enrolled this summer. Burke said 250 to 300 people will be enrolled eventually, all of them in the military health system and admitted through military hospitals.

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