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

197

1 dissimilar are they.
2 How similar is the baculovirus from the
3 mammalian-derived product versus the stripped envelope
4 product of immune response? In designing the trials
5 in the future, can one reasonably feel that they are
6 -- are they relatively similar or are they going to
7 get quite different responses?
8 In some respects, the issue, as Don looked
9 at, is this issue of: Well, what are the criteria?
10 So far if we look at the criteria, are you safe or
11 immunogenic? As I said, I think every product tested
12 so far has been safe and immunogenic.
13 Then how do we discriminate or do we
14 decide to go ahead with all? Is that possible within
15 the framework of this large, simple trial? I think
16 that's a very difficult conundrum.
17 I'm not sure we've spent enough time
18 looking at the Phase II programs and really saying:
19 If we do these in parallel while we're trying to plan
20 some larger trial, whether it's simple or not simple,
21 will we be able to get confidence that some of these
22 vaccines are relatively similar to each other?
NEAL R. GROSS
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