[Minutes, National Advisory Allergy and Infectious Diseases Council, AIDS Division, Combined Advisory Committee (1991: Chevy Chase, Maryland)] [partial copy]

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172
the machinery works, that is one issue. Issue two is that,
in fact, I suspect that the way in which we are going to
make progress in vaccine development in this disease is that
man is going to teach us as much about what is happening in
the monkey as vice versa.
There is precedent for that in other areas, so
that the bottom line is, we feel that it is important to
know what is happening immunologically in patients in the
less developed countries and compare and contrast that with
patients in the places where these trials are currently
going on, to tell us whether there may be something
different about these populations in terms of their immune
response.
Do we have a set of easy clear-cut criteria for a
Phase III trial? No, no one does. In fact yesterday you
heard a discussion in which Tony indicated we are under some
pressure now to just do an efficacy trial with one of the
vaccines that is out there, even though there is absolutely
no evidence that that vaccine is doing anything other than
producing non-specific antibody responses in man.
So we believe that the movement to Phase Ill
trial will be based, I think, on a judgment call of a group
of senior scientists that we will put together to advise us
based on the best knowledge that we have at that time.
That is not as satisfying as being able to put on