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

[ )LPARTMI"ENT OF HEALTH & HUMAN SERVICES Public tH,,tc "uI
National Institutes of..
Bethesda, Maryland 20t92
Charles C.J. Carpenter, M.D.
Professor of Medicine T 2 8
Brown University
The Miriam Hospital
164 Summit Avenue
Providence, Rhode Island 02906
Dear Dr. Carpenter:
The Fiscal Year 1993 Department of Defense (DOD) Appropriation
(P.L. 102-396) identifies $20 million for AIDS research and
specifically states that the funds may be used for GP-160 vaccine
trials unless "the Secretary of Defense, the Director of the
National Institutes of Health, and the Commissioner of Food and
Drugs submit to the Committees on Appropriations of the Senate
and House of Representatives a written certification containing a
determination of such officials that the large-scale Phase III
clinical investigation should not proceed, the reasons for that
determination, and an assessment of the GP-160 vaccine."
In response to this directive, Dr. Bernadine Healy, Director, I1Hi
is convening a meeting of outside experts, the Food and Drug
Administration (FDA) and the DOD to provide recommendations to
the NIH Advisory Committee to the Director (ACD) regarding the
scientific merits of a large-scale clinical investigation of the
MicroGeneSys GP-160 vaccine candidate in HIV seropositive
individuals. Specifically, we would like you to consider the
following questions in formulating your advice:
1. What is the ourrent scientific assessment of the
MicroGeneSys GP-160 vaccine candidate as a therapeutic
agent?
2. Based on the scientific merit of the GP-160 vaccine
should a large-scale efficacy trial be initiated at
this time in HIV seropositive individuals?
3. Since no formal protocol is available at this time,
what should be the role of NIH over the next six months
in reviewing potential protocol designs?
4. Should 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, rationale and optimum design of such a
comparative trial?