Table 5.
Peak individual animal measurements of study endpoints following lethal MPXV challenge.
| Study Group Assignment | Study ID | Animal ID | Peak PRNT50 Pre-challengea | Peak PRNT50 Post-challengea | Peak Lesion Count | Peak Viral Load copies/mlb |
|---|---|---|---|---|---|---|
| Controls | Study 1c | 4463 | <10 | 520 (d11) | >3250 (d6) | 6.70E+07 (d11) |
| 4465 | <10 | 88 (d11) | >3250 (d6) | 3.34E+07 (d11) | ||
| 4466 | <10 | 400 (d6) | >3250 (d6) | 2.02E+08 (d8) | ||
| Mean | <10 | 263 | >3250 | 7.67E+07 | ||
| ACAM2000 + Placebo | Study 1c | 4458 | 1408 (d28) | >10240 (d12) | 3 (d6) | <5.00E+03 (d0) |
| 4460 | 160 (d28) | >10240 (d12) | 0 | <5.00E+03 (d0) | ||
| 4464 | 400 (d42) | >10240 (d6) | 31 (d9) | <5.00E+03 (d0) | ||
| 4467 | 80 (d42) | >10240 (d6) | 11 (d9) | <5.00E+03 (d0) | ||
| 4470 | 1360 (d28) | >10240 (d6) | 7 (d6) | <5.00E+03 (d0) | ||
| 4473 | 400 (d42) | >10240 (d6) | 3 (d6) | <5.00E+03 (d0) | ||
| Mean | 397 | >10240 | 9.2 | <5.00E+03 | ||
| Study 2d | A12660 | 83 (d30) | 8925 (d30) | 0 | <1.00E+02 (d3) | |
| A12662 | 41 (d14) | 1794 (d30) | 0 | 5.24E+02 (d3) | ||
| A12712 | 195 (d30) | 195 (d0) | 0 | <1.00E+02 (d3) | ||
| Mean | 87 | 1462 | 0 | 1.74E+04 | ||
| Study 3e | 4900 | 46 (d28) | 5579 (d12) | 2 (d3) | 1.26E+05 (d18) | |
| 4908 | 270 (d28) | >10240 (d6) | 3 (d9) | 9.74E+03 (d15) | ||
| 4916 | 15 (d28) | >10240 (d6) | 6 (d6) | 6.97E+03 (d15) | ||
| Mean | 57 | 8363 | 3.7 | 2.05E+04 | ||
| ACAM2000 + Tecovirimat | Study 1c | 4459 | 1280 (d45) | >10240 (d6) | 1 (d6) | 6.04E+03 (d15) |
| 4461 | 93 (d45) | >10240 (d24) | 10 (d9) | 2.54E+04 (d9) | ||
| 4469 | 16 (d28) | 5120 (d28) | TNTC (d6) | 7.18E+05 (d6) | ||
| 4472 | 136 (d28) | >10240 (d6) | 5 (d9) | <5.00E+03 (d0) | ||
| 4474 | 256 (d14) | >10240 (d6) | 312 (d6) | 5.42E+04 (d3) | ||
| 4476 | 120 (d14) | >10240 (d6) | TNTC (d6) | 6.26E+04 (d6) | ||
| 4477 | 1024 (d45) | >10240 (d6) | 0 | <5.00E+03 (d0) | ||
| Mean | 188 | 9223 | 975.42 | 1.89E+04 | ||
| Study 2 | A12673 | 41 (d7) | 662 (d12) | 2800 (d9) | 2.03E+08 (d9) | |
| A12720 | N/A | 5146 (d30) | 495 (d9) | 3.26E+06 (d6) | ||
| A12721 | N/A | 10779 (d30) | 230 (d9) | 9.04E+04 (d6) | ||
| Mean | N/A | 3324 | 1175.00 | 3.91E+06 | ||
| Study 3e | 4907 | 61 (d28) | >10240 (d12) | 25 (d9) | 1.04E+04 (dl5) | |
| 4910 | 72 (d28) | >10240 (d6) | 6 (d6) | <5.00E+03 (d3) | ||
| 4912 | 25 (d28) | >10240 (d6) | 203 (d9) | 1.20E+04 (d9) | ||
| Mean | 48 | >10240 | 78.00 | 8.55E+03 |
Parentheses indicate the day when the peak value was initially observed, subsequent to ACAM2000 vaccination or MPXV challenge. Mean values incorporating any ULOQ values represent a lower bound for the group mean.
In Study 1 PRNT50 was measured for VACV, in Studies 2 and 3 MPXV was used to determine PRNT50. Mean values presented are geometric means If no samples measured over 50% neutralization, or logit analysis failed to converge to a meaningful result, value reported is N/A.
Mean values presented for viral load are geometric means.
Peak PRNT of 10240 is the ULOQ. Peak lesion count of 3250 is the ULOQ reported when lesions are too numerous to count. LLOQ for viral genome count is 5000. This value is reported for cases where no genomes were detected by PCR.
LLOQ for viral genome count is 100.
Peak PRNT of 10240 is the ULOQ. LLOQ for viral genome count is 5000.