Table 2.
Hazard ratios of COVID-19 (A) per tenfold increase or (B) per standard deviation increase in each D35 marker in baseline negative per-protocol vaccine recipients (U.S. study sites)
| A | ||||||
|---|---|---|---|---|---|---|
| D35 Antibody Marker | No. cases/No at-riska | Hazard Ratio per 10-fold Increase | P value (2-sided) | Q valueb | FWERb | |
| Point Est. | 95% CI | |||||
| Anti Spike IgG (BAU/ml) | 12/15,294 | 0.36 | (0.20, 0.63) | <0.001 | 0.007 | 0.005 |
| Anti RBD IgG (BAU/ml) | 12/15,294 | 0.35 | (0.18, 0.69) | 0.002 | 0.012 | 0.013 |
| PsV-nAb ID50 (IU50/ml) | 12/15,294 | 0.39 | (0.19, 0.82) | 0.013 | 0.031 | 0.030 |
| B | ||||||
| D35 Antibody Marker | No. cases/No at-riska | Hazard Ratio per Standard Deviation-Increment Increase | ||||
| Point Est. | 95% CI | |||||
| Anti Spike IgG (BAU/ml) | 12/15,294 | 0.52 | (0.36, 0.75) | |||
| Anti RBD IgG (BAU/ml) | 12/15,294 | 0.51 | (0.33, 0.79) | |||
| PsV-nAb ID50 (IU50/ml) | 12/15,294 | 0.49 | (0.28, 0.86) | |||
Analyses were adjusted for baseline risk score. Maximum failure event 59 days post Day 35 visit.
aNo. at-risk = estimated total number of baseline SARS-CoV-2 negative per-protocol vaccine recipients not experiencing the COVID-19 primary endpoint or infected through 6 days post Day 35 visit; no. cases = number of this cohort with an observed COVID-19 primary endpoint at least 7 days after D35 and prior to the data cut-off April 19, 2021. P values are not shown for B because they are structurally identical to those for A.
bQ value and FWER (family-wise error rate) are computed over the set of p values for the three quantitative markers using the Westfall and Young permutation method (10,000 replicates).