Table 3.
Summary of ELISA GMCs for toxin A and toxin B on Days 0, 14, 30, and 60 (PP set).
|
C. difficile toxoid vaccine (N = 67) |
||||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Overall |
Seropositivea |
Seronegativea |
Placebo (N = 34) |
||||
| Visit | GMC | 95% CI | GMC | 95% CI | GMC | 95% CI | GMC | 95% CI |
| Toxin A IgG (EU/mL) | ||||||||
| Day 0 | 0.91 | 0.81;1.01 | 2.37 | 1.88;3.00 | 0.75 | NC | 0.90 | 0.76;1.06 |
| Day 14 | 15.53 | 8.73;27.63 | 600.22 | 226.41;1591.19 | 7.58 | 4.73;12.15 | 0.91 | 0.76;1.08 |
| Day 30 | 48.10 | 33.05;70.00 | 472.18 | 238.53;934.70 | 30.71 | 22.36;42.17 | 0.88 | 0.76;1.02 |
| Day 60 | 96.06 | 78.79;117.11 | 338.66 | 226.79;505.72 | 75.00 | 64.04;87.82 | 0.87 | 0.75;1.02 |
| Toxin B IgG (EU/mL) | ||||||||
| Day 0 | 1.36 | 0.97;1.93 | 4.19 | 2.90;6.07 | 0.40 | NC | 1.06 | 0.72;1.55 |
| Day 14 | 11.70 | 5.28;25.92 | 144.90 | 66.20;317.16 | 0.75 | 0.45;1.24 | 1.03 | 0.71;1.49 |
| Day 30 | 38.64 | 21.88;68.25 | 194.12 | 110.80;340.09 | 6.61 | 3.74;11.69 | 1.05 | 0.72;1.53 |
| Day 60 | 94.04 | 66.81;132.38 | 219.12 | 150.27;319.52 | 37.28 | 25.24;55.06 | 1.10 | 0.75;1.61 |
a
Participants who were seropositive by ELISA (N = 11 and 35 for toxins A and B, respectively) or seronegative by ELISA (N = 56 and 32 for toxins A and B, respectively) at baseline.
NC = not calculated.