A blue ribbon panel convened last Thursday by NIH ChiefBernadine Healy concluded that all leading AIDS vaccinecandidates -- not just the one developed by MicroGeneSys Inc.-- should be tested.

The U.S. Senate recently appropriated $20 million to the Armyto conduct clinical trials in seropositive individuals ofMicroGeneSys' AIDS vaccine, composed of the HIV envelopeprotein gp160. Since then, many in the research establishmenthave been seething over this "end run around peer review."

Not surprisingly, then, it soon became clear at Thursday'sdiscussion that the scientists were unlikely to recommendtesting of just the MicroGeneSys vaccine. University ofWashington virologist Lawrence Corey compared vaccinesunder development, some of which appeared as ready asMicroGeneSys' for clinical trials. Franklin Volvovitz, presidentof MicroGeneSys of Meriden, Conn., charged that Corey's datawere biased. However, AIDS activist Jesse Dobson suggestedthat the person most likely to be biased is the companypresident.

From that point on, the panel focused on how all the leadingvaccines could be tested most effectively and quickly.

-- Huge, simple trial. Dobson said any trial should collectscientific information for future studies in case all the vaccinesfailed. Sam Broder, director of the National Cancer Institute,noted that HLA (human leukocyte antigen -- histocompatabilitycomplex) type might affect responses to different vaccines.

-- Endpoints. The panel debated whether the number of CD4cells adequately reflect a vaccine's efficacy. Dobson saidpatients' well-being should also be considered.

-- Children's studies. Diana Wara, a pediatrician at theUniversity of California, San Francisco, suggested that resultscould be obtained faster and with fewer patients if trials wereconducted on children. Thirty percent of babies born toinfected women are themselves infected with HIV, and of thoseabout 20 percent become very ill before their first birthday.The question, though, is how well these results wouldextrapolate to adults.

After the meeting, Healy told BioWorld that NIH would haveliked to do the vaccine trials, but the money had not beenavailable. The $20 million congressional appropriation wouldnot be sufficient for the kinds of trials the panel is anticipating,she implied. "We're looking at $100 million," she said.

A second meeting is scheduled for Nov. 23, when the panel willattempt to reach a consensus as to exactly what itsrecommendations should be.

Among the other panel members were: Chairman AnthonyFauci, director of the National Institute of Allergy andInfectious Diseases; Co-chairman Charles C.J. Carpenter,professor of medicine at Brown University; David Kessler,commissioner of the FDA; Dani P. Bolognesi, director of theCenter for AIDS Research at Duke University Medical Center;and Theodore Cooper, chairman of the board and chiefexecutive officer of Upjohn Co.

-- David C. Holzman Special to BioWorld

(c) 1997 American Health Consultants. All rights reserved.

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