Panel to Review GP160 Vaccine Candidate: Report of the Meeting

INTRODUCTION

In the Defense Department appropriation bill for fiscal year
1993, Congress designated $20 million in federal funds to support
a large-scale phase III clinical trial to test the efficacy of a
specific candidate vaccine. Known as gpl60, the recombinant
vaccine is produced using a baculovirus system by MicroGeneSys
Inc., a biotechnology company that is based in Meriden,
Connecticut. Although the congressional action singled out the
MicroGeneSys product, more than a dozen AIDS vaccine candidates
are currently under development by companies or as joint privatepublic sector projects in the United States and Europe.
The Defense Department appropriations bill indicates that
the Walter Reed Army Institute for Research (WRAIR) will conduct
the phase III clinical trial on the MicroGeneSys gpl60 candidate
vaccine. However, Congress charged the National Institutes of
Health (NIH) with determining the scientific merits of that
vaccine, which is being developed for both preventive and
therapeutic applications. The legislation also calls upon the
Food and Drug Administration (FDA) to join with NIH in evaluating
this vaccine product as it is considered for a large-scale
clinical trial.
Specific language in the Defense Department's appropriations
bill mandates the NIH Director, the Commissioner of FDA, and the
Secretary of the Department of Defense to provide a report to
Congress within six months on the merits of the MicroGeneSys
gpl60. Congress also added an amendment to the bill specifying
what should be done if, following this evaluation, the gpl60
vaccine is deemed not worthy or not ready for a large-scale
clinical trial. The amendment indicates that, in such a case, the
Secretary of Defense, NIH Director, and FDA Commissioner all must
certify their objections, and then "the Secretary of Defense may
use this funding for other AIDS research needs...."
To carry out this charge from the Congress, NIH Director
Bernadine Healy convened an ad hoc panel on November 5, 1992, to
participate in the first of an anticipated series of advisory
meetings. The meeting participants included NIH and FDA
officials, representatives from the Department of Defense, AIDS
researchers from federal agencies and universities,
representatives from AIDS community interest organizations, and
experts from related disciplines with special interests in
vaccine and drug development, nursing, medical ethics, and the
law.
Direct sponsorship of a specific clinical trial for the
Department of Defense to conduct is an unusual, if not
unprecedented, step for Congress, Dr. Healy, other federal
officials, and many members of the wider biomedical research
community have noted. "The role of the panel...will be to put the
brakes on this efficacy trial...if and only if...the scientific
merits of gpl60 are not compelling enough to make it a worthy
candidate," she said. "I have concerns and reservations about the