Table 1.
D29 antibody marker response frequencies and geometric means by COVID-19 outcome status, for all geographic regions pooled as well as separately by geographic region
| Severe-Critical COVID-19 Cases | Moderate COVID-19 Cases | Moderate to Severe-Critical COVID-19 Cases | Non-cases | Comparison: Severe-Critical COVID-19 Cases to Non-cases | Comparison: Moderate COVID-19 Cases to Non-cases | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| D29 Marker | N | Pos Resp Freq | GM (95% CI) | N | Pos Resp Freq | GM (95% CI) | N | Pos Resp Freq | GM (95% CI) | N | Pos Resp Freq | GM (95% CI) |
Resp Freq Diff (Cases – Non-cases) |
Ratio of GM (Cases/ Non-cases) |
Resp Freq Diff (Cases – Non-cases) |
Ratio of GM (Cases/ Non-cases) |
| All geographic regions pooled | ||||||||||||||||
| nAb-ID50 (IU50/ml) | 42 | 30.9% (18.5, 46.8%) | 4.28 (3.15, 5.82) | 332 | 39.7% (34.5, 45.1%) | 5.02 (4.48, 5.63) | 373 | 38.5% (33.7, 43.6%) | 4.92 (4.42, 5.48) | 774 | 46.1% (41.9, 50.4%) | 6.06 (5.50, 6.67) | -15.2% (-28.3, 1.3%) | 0.71 (0.51, 0.98) | -6.5% (-13.2, 0.4%) | 0.83 (0.71, 0.96) |
| Spike IgG (BAU/ml) | 42 | 80.9% (65.6, 90.4%) | 29.35 (20.99, 41.05) | 332 | 82.0% (77.4, 85.7%) | 29.04 (25.92, 32.53) | 373 | 81.8% (77.5, 85.4%) | 28.98 (26.02, 32.28) | 774 | 86.1% (83.0, 88.8%) | 35.24 (32.23, 38.54) | -5.2% (-20.7, 4.8%) | 0.83 (0.59, 1.18) | -4.2% (-9.4, 0.7%) | 0.82 (0.71, 0.95) |
| RBD IgG (BAU/ml) | 42 | 80.9% (65.6, 90.4%) | 32.50 (24.00, 44.02) | 332 | 78.4% (73.6, 82.5%) | 28.65 (25.81, 31.80) | 373 | 78.6% (74.1, 82.5%) | 28.96 (26.23, 31.96) | 774 | 81.9% (78.4, 85.0%) | 33.49 (30.86, 36.34) | -1% (-16.6, 9.1%) | 0.97 (0.71, 1.33) | -3.5% (-9.2, 1.9%) | 0.86 (0.75, 0.98) |
| Latin America | ||||||||||||||||
| nAb-ID50 (IU50/ml) | 31 | 25.7% (13.0, 44.5%) | 3.77 (2.74, 5.20) | 258 | 40.7% (34.8, 46.8%) | 5.28 (4.60, 6.05) | 288 | 38.9% (33.4, 44.7%) | 5.08 (4.47, 5.77) | 197 | 52.7% (44.8, 60.5%) | 7.03 (5.85, 8.44) | -27% (-41.9, -6.7%) | 0.54 (0.37, 0.78) | -12% (-21.8, -2%) | 0.75 (0.60, 0.94) |
| Spike IgG (BAU/ml) | 31 | 80.6% (62.1, 91.3%) | 29.65 (20.28, 43.35) | 258 | 81.8% (76.5, 86.0%) | 28.89 (25.34, 32.94) | 288 | 81.6% (76.6, 85.7%) | 28.85 (25.48, 32.66) | 197 | 86.4% (80.7, 90.7%) | 34.90 (29.87, 40.78) | -5.8% (-24.8, 6.3%) | 0.85 (0.56, 1.28) | -4.7% (-11.4, 2.5%) | 0.83 (0.68, 1.01) |
| RBD IgG (BAU/ml) | 31 | 80.6% (62.1, 91.3%) | 32.21 (22.90, 45.32) | 258 | 78.6% (73.2, 83.2%) | 28.36 (25.21, 31.91) | 288 | 78.8% (73.7, 83.1%) | 28.62 (25.60, 31.99) | 197 | 84.0% (77.7, 88.8%) | 33.80 (29.31, 38.96) | -3.4% (-22.5, 9.1%) | 0.95 (0.66, 1.38) | -5.3% (-12.6, 2.5%) | 0.84 (0.70, 1.01) |
| South Africa | ||||||||||||||||
| nAb-ID50 (IU50/ml) | 18 | 42.8% (21.3, 67.4%) | 5.64 (3.36, 9.46) | 181 | 43.2% (35.0, 51.8%) | 6.18 (4.99, 7.65) | ||||||||||
| Spike IgG (BAU/ml) | 18 | 84.0% (57.6, 95.3%) | 35.44 (21.34, 58.87) | 181 | 88.5% (82.4, 92.6%) | 39.40 (32.89, 47.20) | ||||||||||
| RBD IgG (BAU/ml) | 18 | 74.9% (46.4, 91.1%) | 36.29 (21.07, 62.52) | 181 | 84.7% (77.8, 89.7%) | 36.29 (30.82, 42.72) | ||||||||||
| United States | ||||||||||||||||
| nAb-ID50 (IU50/ml) | 67 | 35.9% (25.1, 48.2%) | 4.13 (3.45, 4.94) | 396 | 41.3% (35.8, 46.9%) | 5.31 (4.72, 5.97) | ||||||||||
| Spike IgG (BAU/ml) | 67 | 82.1% (70.8, 89.7%) | 27.87 (22.01, 35.29) | 396 | 85.3% (80.7, 89.0%) | 34.61 (30.56, 39.19) | ||||||||||
| RBD IgG (BAU/ml) | 67 | 79.1% (67.5, 87.4%) | 28.51 (22.80, 35.65) | 396 | 79.5% (74.4, 83.9%) | 32.61 (29.10, 36.55) | ||||||||||
Analysis based on baseline SARS-CoV-2 seronegative per-protocol vaccine recipients. Median (interquartile range) days from vaccination to D29 was 29 (2) for all regions pooled, 29 (2) for the United States, 29 (3) for Latin America, and 29 (2) for South Africa.
BAU antibody binding units, CI confidence interval, GM geometric mean, IU international units, nAb-ID50 50% inhibitory dilution neutralizing antibody, Pos Resp Freq positive response frequency, RBD receptor binding domain, Resp Freq Diff response frequency difference.
For the binding antibody assays, positive response was defined by having an IgG concentration above the specified positivity cut-off, with a separate cut-off for each antigen (10.8424 BAU/ml for Spike and 14.0858 BAU/ml for RBD; Table S10). Positive response for nAb-ID50 was defined by a D1 nAb-ID50 titer <LLOQ (LLOQ = 4.8975 IU50/ml) with quantifiable D29 nAb-ID50 ( ≥ LLOQ), or by D1 nAb-ID50 > LLOQ with at least a fourfold increase in D29 nAb-ID50.