Summary Statement: ADARC Program Project on HIV/SIV Vaccine Development

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1 P01 A143042-01 18 SEP
Ho, David D.
stage of HIV vaccine research. A large number of permutations and
combinations can be imagined with all of the various parameters that are going
to be investigated - MVA versus DNA vaccines, a number of different B cell
antigens (loop-deleted, deglycosylated, pseudovirions, CD4-env complexes,
monomeric versus oligomeric envelope), and several different adjuvants.
Consequently, the investigators plan to initially study immunogenicity in
guinea pigs. They further acknowledge that guinea pigs are not non-human
primates, and so the immunogenicity experiments that they plan to perform in
order to evaluate the antigen candidates may not be exactly translatable.
Although the applicants state that details of the immunization and challenge
experiments go be carried out in the last few years of the 5-year period are
somewhat sketchy, the details that they do provide suggest that the
investigators will not be testing for the development of any mucosal immune
response which will probably be critical for a potential HIVvaccine. The
envelope complementation assay is neither referred to nor described. There is
no detail given on how the DNA vaccines will be produced.
Even though the investigators have outstanding qualifications to conduct the
research, because of the existing flaws, the enthusiasm for this project is
relatively low at the very good range.
The facilities are outstanding.
The budget could not be determined.
Human Subjects: code 10
Gender and Minority Representation: not applicable
Animal WNelfare: code 30
Budget: The budget, as presented, cannot be evaluated.
IRG Action: This Jtreceived a priority score in the good range with a
numerical value o 254.
Administrative Note: The budget, as written, is incomplete and lack details.
Therefore, the committee has recommended that a detailed budget be
resubmitted by the applicants.
CORE A: Molecular Virology Core (Drs. D. Ho and C. Cheng-Mayer)
Critique: The comments below represent essentially unedited comments from the
reviewers of this application. They are included to indicate the range of
comments made during the discussion, and may not reflect the final thinking of
the committee. The RESUME and OVERALL CRITIQUE sections above summarize the
final opinion of the committee after the discussion.

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