Table 4.
Th1 (A. IFN-γ release) and Th2 (B. IL-4 release) responses.
| Day | Saline |
SCTV01C |
|||
|---|---|---|---|---|---|
| N = 6 | 20 μg, N = 12 | 40 μg, N = 11 | Total, N = 23 | ||
| T cell INF-gamma (spot per 10⁶ PBMC) | |||||
| Day 0 | GMC (95% CI) | 100 (36, 280) | 46 (24, 89) | 105 (64, 172) | 68 (45, 104) |
| Day 14 | GMC (95% CI) | 106 (57, 198) | 146 (110, 195) | 170 (111, 260) | 157 (125, 198) |
| Fold-Increase (95% CI) | 1.1 (0.6, 1.8) | 3.1 (1.6, 6.3) | 1.6 (0.9, 2.9) | 2.3 (1.5, 3.6) | |
| GMR (95% CI) | 1.5 (0.9, 2.7) | 1.6 (0.9, 2.7) | 1.6 (1.0, 2.6) | ||
| p value | 0.1208 | 0.0924 | 0.0753 | ||
| T cell IL-4 (spot per 10⁶ PBMC) | |||||
| Day 0 | GMC (95% CI) | 20 (7, 59) | 18 (7, 46) | 18 (9, 35) | 18 (10, 31) |
| Day 14 | GMC (95% CI) | 20 (5, 81) | 53 (28, 99) | 41 (18, 98) | 47 (29, 76) |
| Fold-Increase (95% CI) | 1.0 (0.3, 3.6) | 2.9 (1.0, 8.3) | 2.4 (0.6, 8.6) | 2.6 (1.2, 5.6) | |
| GMR (95% CI) | 2.6 (0.8, 8.4) | 2.1 (0.6, 6.7) | 2.3 (0.8, 6.8) | ||
| p value | 0.1054 | 0.2292 | 0.1198 | ||
Fold-Increase = Fold increase over baseline; GMC = Geometric Mean Concentration; GMR = Fold increase over control (saline).
p value was calculated by comparison of control group and SCTV01C group, through an ANCOVA model adjusted by log-transformed baseline and interval of vaccination.
For each type of variant, only those with available baseline and post-baseline data are included (iFAS).