Table 7.
Power for Testing that an Immunological Biomarker has Some Surrogate Endpoint Value: H0: VE(s) = VE versus H1: VE(s) varies in s [Sub-Sampling]*.
| Analysis | Counts | Infections | Analysis | Counts | Infections | |
|---|---|---|---|---|---|---|
| Diagnosed Through 24 Months | Diagnosed Through 36 Months | |||||
| True VE(s) | 1Vac Arm |
2Vac Arms |
3Vac Arms |
1Vac Arm |
2Vac Arms |
3Vac Arms |
| BIP + CRPV Design | ||||||
|
VE(s) = 0.50 (Null) |
0.03 | 0.04 | 0.05 | 0.04 | 0.04 | 0.05 |
|
VE(s) = mod increase |
0.27 | 0.35 | 0.41 | 0.43 | 0.58 | 0.68 |
|
VE(s) = large increase |
0.58 | 0.77 | 0.84 | 0.71 | 0.86 | 0.94 |
| BIP Design | ||||||
|
VE(s) = 0.50 (Null) |
0.04 | 0.05 | 0.05 | 0.04 | 0.05 | 0.05 |
|
VE(s) = mod increase |
0.34 | 0.44 | 0.48 | 0.57 | 0.69 | 0.71 |
|
VE(s) = large increase |
0.71 | 0.84 | 0.89 | 0.86 | 0.94 | 0.96 |
| CRPV Design | ||||||
|
VE(s) = 0.50 (Null) |
0.05 | 0.04 | 0.05 | 0.03 | 0.06 | 0.04 |
|
VE(s) = mod increase |
0.1 | 0.11 | 0.13 | 0.15 | 0.17 | 0.2 |
|
VE(s) = large increase |
0.15 | 0.17 | 0.20 | 0.22 | 0.3 | 0.34 |
*
For the BIP + CRPV and BIP designs the BIP has linear correlation 0.8 with the immunological biomarker S. For the BIP + CRPV and CRPV designs, among placebo recipients uninfected at closeout, 10 times more than the number of placebo recipients infected over the first 36 months are crossed over to the vaccine arm and have S measured.