Table 5.
IgG Antibody Titres Against SARS-CoV-2 S-protein (ELISA) at Day 1, 36 and 106 (Per Protocol population).
| Visit Statistic | Low Dose N = 50 |
Medium Dose N = 49 |
High Dose N = 45 |
Overall N = 144 |
|---|---|---|---|---|
| Day 1 | ||||
| n | 50 | 49 | 45 | 144 |
| GMT (95% CI) | 25.6 (24.58, 26.73) |
26.4 (24.07, 29.05) |
25.0 (25.00, 25.00) |
25.7 (24.83, 26.61) |
| Median | 25.0 | 25.0 | 25.0 | 25.0 |
| Min, Max | 25.0, 87.2 | 25.0, 390.8 | 25.0, 25.0 | 25.0, 390.8 |
| p-value: overall dose groups comparisonA | – | – | – | 0.632 |
| Day 36 | ||||
| n | 50 | 49 | 45 | 144 |
| GMT (95% CI) | 329.7 (247.81, 438.73) |
691.6 (494.91, 966.52) |
2116.0 (1642.59, 2725.75) |
758.4 (622.70, 923.79) |
| Median | 300.4 | 780.1 | 2087.7 | 778.4 |
| Min, Max | 25.0, 5566.1 | 25.0, 8637.6 | 116.8, 15,419.5 | 25.0, 15,419.5 |
| p-value: overall dose groups comparisonA | – | – | – | <0.001 |
| p-value: low dose vs medium doseB | – | – | – | 0.005 |
| p-value: medium dose vs high doseB | – | – | – | <0.001 |
| p-value: low dose vs high doseB | – | – | – | <0.001 |
| Day 106 | ||||
| N | 49 | 49 | 45 | 143 |
| GMT (95% CI) | 111.4 (81.26, 152.68) | 201.5 (151.36, 268.31) | 524.8 (407.38, 675.99) | 222.3 (184.72, 267.46) |
| Median | 89.1 | 254.8 | 545.9 | 236.1 |
| Min, Max | 25.0, 5499.7 | 25.0, 2409.7 | 58.4, 6601.7 | 25.0, 6601.7 |
| p-value: overall dose groups comparisonA | – | – | – | <0.001 |
| p-value: low dose vs medium doseB | – | – | – | 0.016 |
| p-value: medium dose vs high doseB | – | – | – | <0.001 |
| p-value: low dose vs high dose B | – | – | – | <0.001 |
CI=confidence interval; DSCF= Dwass, Steel, Critchlow-Fligner; ELISA=enzyme-linked immunosorbent assay; gG=immunoglobulin gamma; GMT=geometric mean titre; Max=maximum; Min=minimum.
A: p-value was calculated using Kruskal Wallis Test for comparison of dose groups.
B: p-value for pairwise dose group comparison was calculated using DSCF multiple comparisons post-hoc procedure. This was calculated only if the Kruskal Wallis test was significant (i.e., p-value for overall dose groups comparison was ≤0.05).