Table 4.
Viremia in human subjects following vaccination with one dose of ChimeriVax-WN02.
| Mean Cmax (PFU/mL) | Mean AUC (PFU/mL) | Mean Duration (Days) | Percentage of viremic subjects * (%) | |
|---|---|---|---|---|
| Phase I | ||||
| 3.0 log10 PFUa (n = 15) | 187 (SD 165) | 312 (SD 259) | 4.7 | 100 |
| 5.0 log10 PFUa (n = 30) | 97 (SD 159) | 173 (SD 252) | 5.1 | 90 |
| Phase II | ||||
| WN003 | ||||
| Part 1 | ||||
| 3.0 log10 PFUa (n = 24) | 47 (95% CI 29, 77) | 156** (95% CI 118, 206) | 4.8 | 92 |
| 4.0 log10 PFUa (n = 40) | 33 (95% CI 23, 46) | 138** (95% CI 113, 168) | 4.1 | 90 |
| 5.0 log10 PFUa (n = 31) | 30 (95% CI 19, 48) | 131** (95% CI 99, 173) | 3.9 | 94 |
| Part 2 | ||||
| 5.0 log10 PFU | ||||
| 1–64 years b (n = 33) | 25 (95% CI 17, 38) | 115** (95% CI 94, 141) | 3.7 | 85 |
| ≥65 years b (n = 31) | 44 (95% CI 27, 72) | 181** (95% CI 131, 249) | 5.5 | 87 |
| WN004 | ||||
| 3.0 log10 PFU b (n = 80) | 43(95% CI 36, 53) | 251(95% CI 219, 295) | 5.9 *** | 73 |
| 50–64 years | 41(95% CI 31, 54) | 240(95% CI 195, 295) | 4.3 *** | 57 |
| ≥65 years | 46(95% CI 35, 60) | 269.2(95% CI 219, 339) | 7 *** | 94 |
| 4.0 log10 PFU b (n = 82) | 55 (95% CI 43, 69) | 288 (95% CI 240, 347) | 5.2 *** | 74 |
| 50–64 years | 53 (95% CI 37, 72) | 275 (95% CI 219, 347) | 4.4 *** | 65 |
| ≥65 years | 58 (95% CI 39, 85) | 309 (95% CI 229, 417) | 6.4 *** | 93 |
| 5.0 log10 PFU b (n = 73) | 51 (95% CI 41, 65) | 269 (95% CI 234, 309) | 4 *** | 75 |
| 50–64 years | 41 (95% CI 30, 56) | 234 (95% CI 191, 288) | 5.8 *** | 72 |
| ≥65 years | 65(95% CI 47, 87) | 309(95% 257, 372) | 3.2 *** | 79 |
a Measured by plaque assay with the crystal violet technique; b Measured by plaque assay with immunostain using a WN virus envelope protein specific monoclonal antibody; * Percentage of subjects with viremia; ** Day 1–14 after vaccination; *** Mean duration among subjects with quantified viremia (≥60 PFU/mL) 95% CI: 95% Confidence interval (lower bound, upper bound).