Table 1:
Anti-Spike and anti-RBD IgG response rates and Geometric Mean Concentrations (GMCs) and pseudovirus calibrated neutralization titer cID50 and cID80 response rates and Geometric Mean Titers (GMTs) by COVID-19 outcome status. Analysis based on baseline negative per-protocol vaccine recipients in the case-cohort set.
| COVID-19 Cases* | Non-Cases | Comparison | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Visit for Marker | Marker | N | Response Rate | GMC or GMT | N | Response Rate | GMC or GMT | Response Rate Difference | Ratio of GM (Cases/Non-Cases) |
| Day 29 | Anti Spike IgG (IU/ml) | 46 | 97.8% (85.4%, 99.7%) | 183 (126, 266) | 1005 | 98.6% (97.4%, 99.2%) | 318 (292, 347) | −0.01 (−0.13, 0.01) | 0.57 (0.39, 0.84) |
| Day 29 | Anti RBD IgG (IU/ml) | 46 | 97.8% (85.4%, 99.7%) | 207 (147, 293) | 1005 | 98.4% (97.2%, 99.1%) | 327 (302, 354) | −0.01 (−0.13, 0.02) | 0.63 (0.44, 0.90) |
| Day 29 | Pseudovirus-nAb cID50 | 46 | 65.2% (50.1%, 77.8%) | 7.6 (5.4, 10.8) | 1005 | 81.7% (78.8%, 84.3%) | 13.0 (11.9, 14.1) | −0.17 (−0.32, −0.04) | 0.59 (0.41, 0.84) |
| Day 29 | Pseudovirus-nAb cID80 | 46 | 43.5% (29.7%, 58.4%) | 18.0 (13.3, 24.2) | 1005 | 63.9% (60.4%, 67.3%) | 29.0 (27.1, 31.0) | −0.2 (−0.35, −0.05) | 0.62 (0.46, 0.84) |
| Day 57 | Anti Spike IgG (IU/ml) | 36 | 100.0% (100.0%, 100.0%) | 1890 (1449, 2465) | 1005 | 99.4% (98.2%, 99.8%) | 2652 (2457, 2863) | 0.01 (0, 0.02) | 0.71 (0.54, 0.94) |
| Day 57 | Anti RBD IgG (IU/ml) | 36 | 100.0% (100.0%, 100.0%) | 2744 (2056, 3664) | 1005 | 99.4% (98.3%, 99.8%) | 3937 (3668, 4227) | 0.01 (0, 0.02) | 0.70 (0.52, 0.94) |
| Day 57 | Pseudovirus-nAb cID50 | 36 | 100.0% (100.0%, 100.0%) | 160 (117, 220) | 1005 | 98.7% (97.6%, 99.3%) | 247 (231, 264) | 0.01 (0.01, 0.02) | 0.65 (0.47, 0.90) |
| Day 57 | Pseudovirus-nAb cID80 | 36 | 97.2% (81.6%, 99.6%) | 332 (248, 444) | 1005 | 98.3% (97.1%, 99.1%) | 478 (450, 508) | −0.01 (−0.17, 0.02) | 0.69 (0.52, 0.93) |
Cases for Day 29 marker correlates analyses are baseline negative per-protocol vaccine recipients with the symptomatic infection COVID-19 primary endpoint diagnosed starting 7 days after the Day 29 study visit. Cases for Day 57 marker correlates analyses are baseline negative per-protocol vaccine recipients with the symptomatic infection COVID-19 primary endpoint diagnosed starting 7 days after the Day 57 study visit.
N is the number of participants with Day 1, 29, 57 antibody marker data included in data analyses (for Non-Cases and for COVID-19 Cases for Day 57 marker correlates analyses). For COVID-19 Cases for Day 29 marker correlates analyses, N is the number with Day 1, 29 antibody marker data included in analyses (Day 57 marker data are not used in Day 29 marker correlates analyses).
GM, geometric mean; GMC, geometric mean concentration; GMT, geometric mean titer.
cID50 and cID80: ID50 and ID80 neutralizing antibody (nAb) titers calibrated to the WHO International Standard.