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

121

1 actually, this is prevent disease perhaps, rather than
2 infection.
3 Are these vaccines immunogenic in this age
4 group? That's very important. These are heavily
5 glycosylated products. And there's a question in my
6 mind as well as in many others about whether they will
7 be adequately immunogenic in newborns.
8 The design of this trial is a Phase I
9 double blind placebo-controlled study. Again, the
10 newborns are to receive the first four vaccines within
11 the first three days of life. One hundred and twenty
12 infants will be entered, and they will receive one of
13 two vaccines or the adjuvant as the control.
14 The next slide backwards, please, moves
15 forward in the program to ACTG 218, which asks the
16 question: Are envelope-based HIV vaccines and their
17 adjuvants safe in infected children?
18 These, then, are children older, already
19 proven infected, asking the same kinds of questions in
20 children that you've heard described in adults this
21 afternoon.
22 We want to know, of course, whether the
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