Table 3.
Antibody concentrations (GSK 22F-inhibition ELISA) and OPA titres against pneumococcal vaccine serotypes and cross-reactive serotypes 6A and 19A (ATP immunogenicity cohort)
| Antibody responses |
OPA responses |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| pre-vacc |
post-dose 2 |
pre-vacc |
post-dose 2 |
|||||||||
| N | % ≥ 0.2 μg/ml (95% CI) | GMC (95% CI) | N | % ≥ 0.2 μg/ml (95% CI) | GMC (95% CI) | N | % ≥ 8 (95% CI) | GMT (95% CI) | N | % ≥ 8 (95% CI) | GMT (95% CI) | |
| Vaccine serotypes | ||||||||||||
| 1 | 59 | 5.1 (1.1–14.1) | 0.04 (0.03–0.05) | 57 | 100 (93.7–100) | 3.20 (2.68–3.84) | 58 | 12.1 (5.0–23.3) | 5.8 (4.3–7.8) | 57 | 96.5 (87.9–99.6) | 108.7 (79.5–148.6) |
| 4 | 59 | 23.7 (13.6–36.6) | 0.06 (0.04–0.09) | 57 | 100 (93.7–100) | 6.54 (5.47–7.82) | 57 | 19.3 (10.0–31.9) | 11.8 (6.3–22.1) | 55 | 100 (93.5–100) | 2716.7 (2149.0–3434.2) |
| 5 | 59 | 5.1 (1.1–14.1) | 0.04 (0.03–0.05) | 57 | 100 (93.7–100) | 3.05 (2.40–3.87) | 58 | 1.7 (0.0–9.2) | 4.3 (3.7–5.0) | 57 | 94.7 (85.4–98.9) | 71.9 (51.8–99.7) |
| 6B | 59 | 6.8 (1.9–16.5) | 0.03 (0.03–0.04) | 57 | 82.5 (70.1–91.3) | 0.78 (0.57–1.08) | 46 | 39.1 (25.1–54.6) | 38.7 (16.2–92.0) | 50 | 94.0 (83.5–98.7) | 1202.9 (701.3–2063.0) |
| 7F | 59 | 8.5 (2.8–18.7) | 0.04 (0.03–0.06) | 57 | 100 (93.7–100) | 4.50 (3.80–5.33) | 51 | 98.0 (89.6–100) | 2454.4 (1587.3–3795.1) | 57 | 100 (93.7–100) | 9161.1 (7254.1–11569.4) |
| 9V | 59 | 1.7 (0.0–9.1) | 0.03 (0.03–0.04) | 57 | 98.2 (90.6–100) | 1.48 (1.20–1.83) | 44 | 68.2 (52.4–81.4) | 138.2 (63.2–302.6) | 43 | 100 (91.8–100) | 4596.5 (3519.4–6003.3) |
| 14 | 59 | 15.3 (7.2–27.0) | 0.11 (0.09–0.14) | 57 | 100 (93.7–100) | 4.51 (3.63–5.61) | 36 | 30.6 (16.3–48.1) | 18.8 (8.4–42.3) | 41 | 100 (91.4–100) | 2246.1 (1621.5–3111.1) |
| 18C | 59 | 13.6 (6.0–25.0) | 0.05 (0.04–0.07) | 57 | 100 (93.7–100) | 10.95 (8.50–14.10) | 33 | 12.1 (3.4–28.2) | 6.4 (4.0–10.3) | 38 | 97.4 (86.2–99.9) | 2045.3 (1161.5–3601.8) |
| 19F | 59 | 25.4 (15.0–38.4) | 0.09 (0.06–0.14) | 57 | 94.7 (85.4–98.9) | 8.52 (5.58–13.00) | 57 | 3.5 (0.4–12.1) | 4.8 (3.7–6.3) | 47 | 89.4 (76.9–96.5) | 693.7 (350.8–1371.6) |
| 23F | 59 | 1.7 (0.0–9.1) | 0.03 (0.03–0.04) | 57 | 87.7 (76.3–94.9) | 1.05 (0.74–1.49) | 49 | 32.7 (19.9–47.5) | 30.4 (12.9–71.4) | 57 | 100 (93.7–100) | 3571.0 (2793.4–4565.1) |
| Cross-reactive serotypes | ||||||||||||
| 6A | 59 | 1.7 (0.0–9.1) | 0.04 (0.03–0.05) | 57 | 19.3 (10.0–31.9) | 0.10 (0.07–0.14) | 54 | 37.0 (24.3–51.3) | 24.0 (12.5–46.3) | 48 | 58.3 (43.2–72.4) | 106.3 (46.3–244.0) |
| 19A | 58 | 17.2 (8.6–29.4) | 0.06 (0.04–0.09) | 57 | 86.0 (74.2–93.7) | 1.36 (0.91–2.03) | 58 | 12.1 (5.0–23.3) | 5.9 (4.2–8.3) | 54 | 83.3 (70.7–92.1) | 171.2 (94.2–311.3) |
N = number of subjects with available results, 95% CI = 95% confidence interval; ATP, according-to-protocol; 22F- inhibition ELISA, 22F-inhibition enzyme-linked immunosorbent assay; OPA, opsonophagocytic activity; GMC, geometric mean concentration; GMT, geometric mean titer.