Table 2.
Vaccine efficacy estimates and comparisons.
| Endpoints | Group | Vaccine Efficacy (%) | Global Randomization (standard) Test1 | Randomization test p-value, pairwise comparisons | 95% Confidence Interval for Vaccine Efficacy2 |
|---|---|---|---|---|---|
| Analysis of SHIV Challenge Phases I & II (full duration) | |||||
| Time to first viremia | K vs M | 11.6 | 0.5671 (0.5611) | 0.8299 | (-163.2, 69.7) |
| L vs M | -54.6 | 0.6278 | (-335.9, 41.9) | ||
| Time to peak viremia | K vs M | 10.3 | 0.8872 (0.8904) | 0.7601 | (-167.3, 69.3) |
| L vs M | -21.6 | 0.9198 | (-254.6, 56.8) | ||
| Time to PSI | K vs M | 12.3 | 0.7177 (0.7060) | 0.7327 | (-161.2, 70.0) |
| L vs M | -37.3 | 0.8188 | (-293.2, 49.7) | ||
| Analysis of SHIV Challenge Phase I (prior to challenge dose escalation) | |||||
| Time to first viremia | K vs M | 64.6 | 0.0704 (0.0712) | 0.1213 | (-55.0, 94.1) |
| L vs M | 78.4 | 0.0456* | (-13.5, 97.8) | ||
| Time to peak viremia | K vs M | 54.9 | 0.0652 (0.0610) | 0.2066 | (-111.2, 92.7) |
| L vs M | 85.3 | 0.0359* | (-21.3, 99.7) | ||
| Time to PSI | K vs M | 58.6 | 0.0606 (0.0642) | 0.1838 | (-93.6, 93.3) |
| L vs M | 87.0 | 0.0319* | (-7.5, 99.7) | ||
1Primary inference drawn from randomization tests; standard p-value included for sensitivity analysis of global test for difference across all groups.
2Confidence intervals do not account for constrained randomization and are to be considered supplementary.
*Value <0.05.