Table 3.
Comparison of correlate of risk results for spike IgG and PsV-nAb ID50 across four randomized, placebo-controlled COVID-19 vaccine efficacy trials (U.S. study sites).
| Vaccine Platforma | Trial | Ab Marker 4 Wks Post-Vaccination | Follow-Up Post Vaccination | Estimated Hazard Ratio per 10-fold Increase in the Marker (95% CI) | P-Value | Q-Value | FWER-Adjusted P-Value |
|---|---|---|---|---|---|---|---|
| mRNA | COVE23 | Spike IgG | 126 days | 0.66 (0.50, 0.88) | 0.005 | 0.014 | 0.010 |
| Ad26 | ENSEMBLE-US24 | Spike IgG | 83 days | 0.62 (0.28, 1.37) | 0.24 | 0.35 | 0.36 |
| Recombinant Protein | PREVENT-1925 | Spike IgG | 73 days | 0.36 (0.20, 0.64) | <0.001 | 0.005 | 0.005 |
| Ad (chimpanzee) | AZD1222 | Spike IgG | 92 days | 0.32 (0.14, 0.76) | 0.009 | 0.017 | 0.015 |
| mRNA | COVE23 | PsV-nAb ID50 | 126 days | 0.42 (0.27, 0.65) | <0.001 | 0.002 | 0.003 |
| Ad26 | ENSEMBLE-US24 | PsV-nAb ID50 | 83 days | 0.38 (0.13, 1.12) | 0.078 | 0.22 | 0.20 |
| Recombinant Protein | PREVENT-1925 | PsV-nAb ID50 | 73 days | 0.39 (0.19, 0.82) | 0.013 | 0.032 | 0.030 |
| Ad (chimpanzee) | AZD1222 | PsV-nAb ID50 | 92 days | 0.28 (0.10, 0.77) | 0.013 | 0.019 | 0.016 |
aCOVE: Moderna mRNA-1273 spike vaccine; ENSEMBLE: Janssen Ad26 vector spike vaccine Ad26.CoV2.S; PREVENT-19: Novavax recombinant spike protein vaccine NVX-CoV2373; AZD1222: AstraZeneca ChAdOx1 nCoV-19 vaccine.