Table 2.
Covariate-adjusted hazard ratios of severe-critical COVID-19 or of moderate COVID-19 per tenfold increase or per standard deviation increase in each D29 antibody marker
| Severe-critical COVID-19 | ||||||||
|---|---|---|---|---|---|---|---|---|
| D29 Marker | No. cases/No. at-risk | HR per 10-fold increase | p-value (2-sided) | FDR-adj p-value | FWER-adj p-value | HR per SD increase | ||
| Pt. Est. | 95% CI | Pt. Est. | 95% CI | |||||
| nAb-ID50 (IU50/ml) | 46/18,163 | 0.35 | 0.13, 0.90 | 0.030 | 0.106 | 0.098 | 0.59 | 0.36, 0.95 |
| Spike IgG (BAU/ml) | 46/18,163 | 0.67 | 0.32, 1.39 | 0.285 | 0.619 | 0.567 | 0.83 | 0.59, 1.17 |
| RBD IgG (BAU/ml) | 46/18,163 | 0.79 | 0.33, 1.85 | 0.583 | 0.633 | 0.793 | 0.90 | 0.63, 1.30 |
| Moderate COVID-19 | ||||||||
| D29 Marker | No. cases/No. at-risk* | HR per 10-fold increase | p-value (2-sided) | FDR-adj p-value** | FWER-adj p-value** | HR per SD increase | ||
| Pt. Est. | 95% CI | Pt. Est. | 95% CI | |||||
| nAb-ID50 (IU50/ml) | 375/18,163 | 0.53 | 0.34, 0.82 | 0.005 | 0.052 | 0.031 | 0.73 | 0.58, 0.91 |
| Spike IgG (BAU/ml) | 375/18,163 | 0.67 | 0.45, 1.01 | 0.057 | 0.114 | 0.146 | 0.83 | 0.69, 1.01 |
| RBD IgG (BAU/ml) | 375/18,163 | 0.59 | 0.37, 0.93 | 0.025 | 0.073 | 0.076 | 0.80 | 0.65, 0.97 |
Analyses were based on baseline SARS-CoV-2 seronegative per-protocol vaccine recipients and adjusted for baseline behavioral risk score and geographic region.
*.No. at-risk = estimated number in the population for analysis, i.e. baseline negative per-protocol vaccine recipients not experiencing the designated COVID-19 endpoint or infected through 6 days post Day 29 visit; no. cases = number of this cohort with an observed designated COVID-19 endpoint (calculated via inverse probability of sampling Day 29 marker weighting).
**q-value and FWER (family-wide error rate) are computed over the set of p values both for quantitative markers and categorical markers using the Westfall and Young permutation method (10000 replicates).
p-values were obtained using a two-sided Wald test.
Cases were counted starting 7 days post Day 29.
BAU antibody binding units, CI confidence interval, FDR false discovery rate, FWER family-wise error rate, HR hazard ratio, IU international units, nAb-ID50 50% inhibitory dilution neutralizing antibody, Pt. Est. point estimate, RBD receptor binding domain, SD standard deviation.