[Minutes, Advisory Committee to the Director GP-160 Meeting (1992: Bethesda, Maryland)]

37

1 There is no evidence to date of immune
2 enhancement. By enhancement, I mean a vaccine induced
3 worsening of immune status; and no data regarding
4 clinical benefit has yet been reported.
5 Nevertheless -- next slide -- Phase II
6 trials are proceeding, based on novel immune responses
7 and the lack of obvious safety issues. However, there
8 is no clear effect on CD4 or viral load, and none use
9 clinical end points as primary outcome variables.
10 In conclusion -- next slide -- we need to
11 identify immunologic responses to -- not of -- to
12 other products, and define their clinical
13 significance. That is, we need to continue doing
14 Phase I trials according to the strategy previously
15 outlined.
16 Second, we need to define the association
17 between clinical outcome and the surrogate markers,
18 CD4, and viral burden. This will be absolutely
19 critical in helping to accelerate the pace of
20 research, and in order to accomplish that, control
21 trials are absolutely essential.
22 Thank you very much.
NEAL R. GROSS
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