Table 6.
Immunogenicity, ACAM1000 and ACAM2000, Phase 1 clinical trials.
| Statistic | Study number/Study vaccine |
|||
|---|---|---|---|---|
| H-300-001 |
H-300-003 | H-400-008 | ||
| ACAM1000 | Dryvax® | ACAM1000 | ACAM2000 | |
| Number of subjects | 30 | 30 | 70 | 100 |
| Major cutaneous reaction | ||||
| No. (%) | 30 (100) | 29 (97) | 70 (100) | 99 (99) |
| 95% Confidence interval | 88, 100 | 83, 100 | 95, 100 | 95, 100 |
| Maximum lesion size (mm) | ||||
| Central lesion, mean (±SD) | 13.4 (1.87) | 12.6 (2.37) | 10.9 (1.76) | 10.3 (1.83) |
| Erythema, mean (±SD) | 25.8 (8.52) | 30.7 (16.09) | 22.8 (15.79) | 35.7 (17.32) |
| Seroconversion, neutralizing antibodies | ||||
| No. (%) | 30 (100) | 29 (97) | 66 (94) | 96 (96) |
| Neutralizing antibodies, Geometric Mean Titer | 142 | 248 | 154 | 225 |
| T cell response No. pos/tested (%) | ||||
| Cytotoxic T lymphocyte | 24/29 (80) | 26/30 (90) | Not tested | Not tested |
| γ-Interferon ELISPOT | 29/29 (100) | 29/30 (97) | ||
| Lymphoproliferation | 28/29 (97) | 21/30 (70) | ||