Table 4. Seropositivity rates and GMTs/GMCs before (pre-challenge) and 1 month after (post-challenge) a polysaccharide challenge dose had been given (booster ATP cohort for immunogenicity).
Study vaccine* | Control vaccine** | ||||||
Antibody | Timepoint to vaccination | N | Seropositivity (%) (95% CI) | GMT or GMC 95% CI) | N | Seropositivity(%) ≥ 1: 8 (95% CI) | GMT or GMC (95% CI) |
SBA-MenA | Pre-challenge | 109 | 47.7 (38.1, 57.5) | 27.8 (18.2, 42.3) | 103 | 25.2 (17.2, 34.8) | 12.2 (8.3, 18.1) |
Post-challenge | 107 | 93.5 (87.0, 97.3) | 390.1 (280.2, 543.0) | 109 | 51.4 (41.6, 61.1) | 46.4 (28.8, 74.7) | |
SBA-MenC | Pre-challenge | 117 | 56.4 (46.9, 65.6) | 31.6 (21.9,45.8) | 116 | 5.2 (1.9, 10.9) | 4.6 (4.0, 5.1) |
Post-challenge | 122 | 88.5 (81.5, 93.6) | 593.5 (398.1, 884.7) | 121 | 18.2 (11.8, 26.2) | 8.7 (6.2, 12.3) | |
Anti-PSA | Pre-challenge | 115 | 23.5 (16.1, 32.3) | 0.21 (0.19, 0.24) | 115 | 5.2 (1.9, 11.0) | 0.16 (0.15, 0.17) |
Post-challenge | 120 | 90.8 (84.2, 95.3) | 4.72 (3.41, 6.52) | 117 | 47.0 (37.7, 56.5) | 0.38 (0.30, 0;48) | |
Anti-PSC | Pre-challenge | 116 | 78.4 (69.9, 85.5) | 0.62 (0.52, 0.73) | 113 | 4.4 (1.5, 10.0) | 0.17, (0.15, 0.18) |
Post-challenge | 119 | 98.3 (94.1, 99.8) | 4.29 (3.57, 5.14) | 121 | 100 (97.0, 100) | 3.58 (3.03, 4.24) |
DTPw-HBV/Hib-MenAC
DTPw-HBV/Hib
PSA/C = serogroup A/C polysaccharide ; % subjects = percentage of subjects with seroprotective/seropositive titre/concentration of at least 1:8 (SBA-MenA/C), 0.3 μg/ml (anti PSA/C), 95% CI = 95% confidence interval
GMT/GMC = geometric mean antibody titre/concentration calculated on all subjects.