Table 5.
Concentration of anti-SE36 IgG1 and IgG3 subclasses.
| Cohort 1 | ||||||||
|---|---|---|---|---|---|---|---|---|
| BK-SE36 Intramuscular | BK-SE36 Subcutaneous | Control (Synflorix® + saline) Intramuscular | ||||||
| n | GMC (95% CI) | n | GMC (95% CI) | n | GMC (95% CI) | |||
| IgG1 | Day 56 | 16 | 13.6 (7.2, 25.4) | 17 | 14.0 (8.9, 22.0) | 10 | 5.2 (1.5, 18.2) | |
| Day 210 | 16 | 16.1 (8.5, 30.4) | 17 | 19.8 (11.9, 33.0) | 8 | 4.7 (0.9, 23.3) | ||
| IgG3 | Day 56 | 16 | 2.2 (0.5, 8.9) | 17 | 1.0 (0.3, 3.7) | 10 | 1.2 (0.2, 8.9) | |
| Day 210 | 16 | 1.9 (0.6, 6.7) | 17 | 0.4 (0.1, 1.2) | 8 | 4.7 (0.5, 46.9) | ||
| Cohort 2 | ||||||||
| IgG1 | Day 56 | 17 | 28.7 (16.6, 49.9) | 16 | 25.5 (12.7, 51.4) | 8 | 4.0 (1.1, 15.1) | |
| Day 210 | 17 | 66.2 (37.9, 115.7) | 16 | 57.5 (38.6, 85.6) | 1 | 3.2 | ||
| IgG3 | Day 56 | 17 | 8.5 (2.9, 24.4) | 16 | 9.7 (2.6, 36.9) | 8 | 0.6 (0.1, 4.3) | |
| Day 210 | 17 | 3.5 (0.9, 13.1) | 16 | 8.0 (2.9, 22.3) | 1 | 0.1 | ||
Day 56, 4 weeks after Dose 2; Day 210, 4 weeks after Dose 3; GMC, geometric mean concentration (95% confidence interval); n, number of subjects.