Table 1. Number and percentage of subjects with a ≥4-fold increase in OprF/I-specific IgG antibody geometric mean titer from day 0 (first vaccination) to day 14 (7 d after second vaccination) (per-protocol-population).
Treatment group | Number of subjects with ratio day 14/day 0 ≥ 4 | % (95% CI)a | |
---|---|---|---|
IC43 100 µg | (n = 30) | 29 | 96.7% (83.3%, 99.4%) |
IC43 100 µg w/o | (n = 30) | 29 | 96.7% (83.3%, 99.4%) |
IC43 200 µg | (n = 30) | 29 | 96.7% (83.3%, 99.4%) |
IC43 50 µg | (n = 11) | 10 | 90.9% (62.3%, 98.4%) |
Placebo | (n = 32) | 0 | 0.0% (0.0%, 10.7%) |
a 95% Confidence intervals were calculated according to the Wilson method recommended by Altman.17 CI, confidence interval; IgG, immunoglobulin G; OprF/I, outer membrane protein OprF/I hybrid vaccine; w/o, without adjuvant.