[Conference Materials, Panel to Review GP-160 Vaccine Candidate (1992: Bethesda, Maryland)]

National Institutes of Health

PANEL TO REVIEW GP-160 VACCINE CANDIDATE
Thursday, November 5, 1992
A committee of experts has been convened by Dr. Bernadine Healy,
Director of the National Institutes of Health to review the scientific
data available on the GP-160 vaccine candidate, in response to the
recently passed Fiscal Year 1993 Department of Defense language.
The committee is charged with evaluating the following:
M What is the current scientific assessment of the MicroGeneSys
GP-160 vaccine candidate as a therapeutic agent?
SBased on the scientific merit of the GP-160 vaccine, should a
large-scale efficacy trial be initiated at this time in HIV
seropositive individuals?
SSince no formal protocol is available at this time, what should be
the role of the NIH over the next six months in reviewing
potential protocol designs?
SShould consideration be given to including several promising
vaccine candidates in a large-scale comparative efficacy trial?
Are additional candidates ready for Phase III testing? What would
be the objective, rational and optimum design of such a
comparative trial?