Table 3.
SARS-CoV-2 Neutralizing Antibody Titres (ND50) Over Timepoints – Day 1, Day 36, and Day 106 (Per Protocol Population).
| Visit Statistic | Low Dose N = 50 |
Medium Dose N = 49 |
High Dose N = 45 |
Overall N = 144 |
Convalescent Subjects (N = 32) |
|---|---|---|---|---|---|
| Day 1 | |||||
| N | 50 | 49 | 45 | 144 | – |
| GMT (95% CI) | 31.0 (31.00, 31.00) |
32.8 (30.48, 35.24) |
31.5 (30.66, 32.37) |
31.8 (30.94, 32.58) |
– |
| Median | 31.0 | 31.0 | 31.0 | 31.0 | – |
| Min, Max | 31.0, 31.0 | 31.0, 232.0 | 31.0, 64.0 | 31.0, 232.0 | – |
| p-value: overall dose groups comparisonA | – | – | – | 0.366 | – |
| Day 36 | |||||
| N | 50 | 49 | 45 | 144 | 32 |
| GMT (95% CI) | 168.7 (125.09, 227.48) |
218.9 (169.41, 282.92) |
545.6 (428.10, 695.37) |
266.0 (225.10, 314.39) |
526.9 (336.47, 825.06) |
| Median | 122.5 | 233.0 | 537.0 | 264.5 | 606.0 |
| Min, Max | 31.0, 3618.0 | 31.0, 1307.0 | 31.0, 2033.0 | 31.0, 3618.0 | 31.0, 6704.0 |
| p-value: overall dose groups comparisonA | – | – | – | <0.001 | – |
| p-value: low dose vs medium doseB | – | – | – | 0.358 | – |
| p-value: medium dose vs high doseB | – | – | – | <0.001 | – |
| p-value: low dose vs high doseB | – | – | – | <0.001 | – |
| p-value: low dose vs convalescentB | – | – | – | 0.001 | – |
| p-value : medium dose vs convalescentB | – | – | – | 0.023 | – |
| p-value: high dose vs convalescent B | – | – | – | >0.999 | – |
| Day 106 | |||||
| N | 49 | 49 | 45 | 143 | – |
| GMT (95% CI) | 63.3 (50.42, 79.48) |
82.4 (64.26, 105.63) |
175.9 (136.02, 227.56) |
95.6 (82.23, 111.08) |
– |
| Median | 31.0 | 77.0 | 211.0 | 89.0 | – |
| Min, Max | 31.0, 1088.0 | 31.0, 1589.0 | 31.0, 1357.0 | 31.0, 1589.0 | – |
| p-value: overall dose groups comparisonA | – | – | – | <0.001 | – |
| p-value: low dose vs medium doseB | – | – | – | 0.366 | – |
| p-value: medium dose vs high doseB | – | – | – | 0.001 | – |
| p-value: low dose vs high doseB | – | – | – | <0.001 | – |
CI=confidence interval; DSCF= Dwass, Steel, Critchlow-Fligner; GMT=geometric mean titre; Max=maximum; Min=minimum; ND50=50% neutralizing dilution.
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.).