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

1 toxoid.
2 These individuals then were randomized to
3 receive one of four different doses of the vaccine or
4 a Hepatitis B control. The reason we inserted a
5 Hepatitis B control in the double blind fashion into
6 this trial is to enable us to detect our immune
7 responses at what we anticipated would be a very noisy
8 system -- a very noisy system, because, after all,
9 these individuals are attempting immunologically to
10 respond to this virus, and immune responses go up and
11 down all of the time.
12 Secondly, there are technical variations;
13 and thirdly, the administration of any immunogen might
14 be expected, in fact, to cause nonspecific changes in
15 the immune system. So the individuals had to be
16 seropositive to HIV and also seropositive for
17 Hepatitis B. That is, they had to have antibody
18 against Hepatitis B as well, and they were prohibited
19 and did not, in fact, take any anti-viral drugs. Next
20 slide, please.
21 They were then randomized to receive a
22 range from 20 to 1280 micrograms of gp-160 or
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