WASHINGTON -- Once again, the fortunes have turned forMicroGeneSys Inc.'s gp160 vaccine for HIV, and this time, thecontroversial single-vaccine clinical trial appears to be dead.
In an action last year that raised the hackles on the back of themedical science community, Congress appropriated $20 millionto the Department of Defense (DOD) for a single-vaccine PhaseIII trial of the Meriden, Conn., company's VaxSyn.
As recently as Aug. 20, MicroGeneSys said that the single-vaccine trial was on. The news was surprising because in thespring, DOD had unexpectedly announced that it was going totransfer the $20 million to the National Institutes of Health tocontribute to a multivaccine trial under the institutes' auspices.
That news also was surprising because Congress had left a wayout of the single-vaccine trial. The heads of NIH, DOD and theFDA could have stopped it by certifying prior to April 6 that itshould not go forward. But the agencies did not do so.
Following MicroGeneSys' announcement in August, Rep. HenryWaxman, D-Calif., chairman of the Subcommittee on Health andthe Environment, requested a briefing on the value of thesingle-vaccine trial from a group that included Kristine Gebbie,national AIDS policy coordinator; Anthony Fauci, director of theNational Institute of Allergy and Infectious Diseases; andEdward Martin, acting assistant secretary of health affairs atDOD. The briefing, which took place in mid-September,convinced Waxman that the trial would be a waste.
"In the opinion of many in the scientific and AIDS-interestedcommunity, in which I concur, this single-vaccine trial is not auseful investment at the present time," Gebbie wrote toWaxman on Sept. 28.
Accordingly, Waxman introduced an amendment to the fiscal1994 DOD appropriations bill on Sept. 30, which quickly passedin the House, to extend the certification period by a year fromthe previous deadline. Edward Kennedy, D-Mass., and PattyMurray, D-Wash., introduced the bill in the Senate.
Last week, a House-Senate conference committee adopted theHouse version of the amendment, and the Senate later passedthe appropriations bill.
That alone probably doomed the trial. In addition, the threeagency heads are now ready to kill it, although they had beenunready to do so in April, a subcommittee aide told BioWorld.
Also, the DOD "would require some evidence of likelihood ofefficacy before we would agree it is scientifically justified toproceed with a trial," Donald Burke, director, the Division ofRetrovirology at Walter Reed Army Institute of Research toldBioWorld. The Army's 2-year old prospective, double-blind,placebo-controlled Phase II trial of gp 160 of 600 HIV positivepatients has yet to yield compelling data.
At the Department of Health and Human Services, VictorZonona, spokesman for HHS chief Donna Shalala, said that theagency favors conducting a multivaccine trial. But the dismalresults reported last week at the Conference on Advances inAIDS Vaccine Development, sponsored by the National Instituteof Allergy and Infectious Diseases suggest that, too, would be awaste.
As Gebbie presciently stated in her Sept. 28 letter to Waxman,"It would be far wiser to allow an appropriate review processto identify more basic research questions essential to thesuccessful development of a vaccine, whether therapeutic orpreventive."
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.