Table 3.
Functional Immunoglobulin G Responses in Human Immunodeficiency Virus Type 1–Exposed Vaccinated Infants
Variable | PACTG 230 |
PACTG 326 |
||||||
---|---|---|---|---|---|---|---|---|
Placebo | VaxGen Vaccine | P Value | Chiron Vaccine | P Value | Placebo | ALVAC/ AIDSVAX | P Value | |
ADCC (B. SF162) | ||||||||
Week 24 | ||||||||
Subjects, no. | 14 | 40 | 36 | 9 | 6 | |||
Median ADCC titer | 70 | ND | 49 | .06a | 49 | 61 | .95a | |
Detectable response, subjects, % | 64 | ND | 36 | .11b | 44 | 67 | .61b | |
Week 52 | ||||||||
Subjects, no. | 12 | 40 | 43 | 11 | 6 | |||
Median ADCC titer | 49 | 49 | .8a | 49 | .8a | 49 | 52 | .07a |
Detectable response, subjects, % | 17 | 15 | 1.00b | 23 | 1.00 | 9 | 50 | .10b |
Neutralization (B. MN) | ||||||||
Week 24 | ||||||||
Subjects, no. | 14 | 40 | 37 | 9 | 8 | |||
Median ID50c | 141 | 110 | .8a | 187.5 | .49a | 76.5 | 105 | .86a |
Response, subjects, % | 36 | 80 | .006b | 72 | .03b | 67 | 63 | 1.00 |
Week 52 | ||||||||
Subjects, no. | 11 | 40 | 43 | 11 | 6 | |||
Median ID50c | 23 | 33 | .22a | 68 | .02a | ND | ND | |
Response, subjects, % | 45 | 50 | 1.00 | 53 | .74b | 9 | 17 |
A P value of < .05 is considered statistically significant.
Abbreviations: ADCC, antibody-dependent cell-mediated cytotoxicity; B. MN, B HIV-1 MN.3; B. SF162, B HIV-1 SF162.LS; ID50, median infectious dose; ND, not done; PACTG, Pediatric AIDS Clinical Trials Group.
By the Wilcoxon test, compared with placebo.
By the Fisher exact test, compared with placebo.
The median value was computed for responders only.