[Email to Bruce Weniger from Haynes W. Sheppard]

3. The advantages of whole killed (multiple antigens, native conformation,
particle presentation) can be accomplished just as well with "pseudovirion"
approaches and they are safer.
This may turn out to be true but there is absolutely no scientific evidence
to support this optimistic prediction. Therefore to pursue these approaches
to the exclusion of whole killed is irrational.
4. The whole killed approach has failed in the SIV system except for
protection due to human xeno-antigens derived from the human cell lines
used to grow the virus. Whole killed monkey-grown virus has only been
tried a few times, and there is some evidence for partial protection. There
simply has not been enough done with this system to draw the conclusion
that it has failed. However, my friends in the SIV business tell me that they
have stopped working on whole killed mainly because they can't get
funding to continue. Again, its not glitzy enough to fare well in peer review.
Leaving aside the virtues of my favorite approach, all approaches to
HIV/AIDS vaccines are suffering from a low and declining level of
private-sector interest and investment, particularly for non-B subtype
vaccines which are the most urgently needed. In this regard, I would
encourage enthusiastic endorsement of, and collaboration with, the
"public sector" efforts such as the International AIDS Vaccine Initiative or
(IAVI) being proposed by the Rockefeller Foundation.
I am convinced that the development of an HIV/AIDS vaccine is both
feasible and absolutely necessary for the control of the global HIV epidemic.
However, it appears that vaccines in general, and HIV/AIDS vaccine in
particular, have been essentially orphaned by the private sector.
The NIH vaccine program will probably continue to do what it does best,
which is study the basic immunology of HIV infection/vaccination and
conduct clinical trials of new candidate products. But without major public
investment in product development, I think the trickling pipeline is going to
dry up very soon.
If you want my opinion about how this committee should focus its influence,
I would suggest that you encourage the formation and funding of
mechanisms that could cut through some of the bureaucracy and the
academic politics, to put resources into the hands of experienced and
product-oriented vaccine development teams. Some have called this the
Manhattan Project approach which is probably not the best analogy.
Something like multiple mini-Manhattan Projects is more like it. To the
extent that such teams are willing and able to produce non-B vaccine
candidates, the domestic and international research communities are ready
and anxious to participate in the evaluation process.
Haynes W. Sheppard, Ph.D.
Viral and Rickettsial Disease Laboratory,
California Department of Health Services.
2151 Berkeley Way, Berkeley, CA 94704
Phone: [phone] Fax: [phone]
Email: [email protected]

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