TABLE 2.
Clinical and bacteriological responses of volunteers in vaccine and placebo groups to challenge with Vibrio cholerae 81 or 3008
| Parametera | Value for the indicated subjects challenged with:
|
|||
|---|---|---|---|---|
|
V. cholerae 81b
|
V. cholerae 3008c
|
|||
| Vaccine (n = 5) | Placebo (n = 5) | Vaccine (n = 12) | Placebo (n = 9) | |
| Subjects shedding the challenge strain | 2 (40) | 5 (100) | 3 (25) | 9 (100) |
| Median CFU per gram of feces(d) | 6 × 104 | 3 × 105 | 2.1 × 104 | 2.3 × 106 |
| Lower quartile (LQ) | 1 × 102 | 1 × 104 | 6.6 × 103 | 3.3 × 105 |
| Upper quartile (UQ) | 2 × 105 | 1 × 107 | 3.4 × 105 | 1.6 × 107 |
| Median duration (days) of shedding (LQ − UQd) | 2 (3-5) | 5 (5-5) | 0 (0-1) | 4 (4-5) |
| Subjects with any diarrhea | 0 | 3 (60) | 0 | 7 (78) |
| Subjects with severe or moderate diarrhea (≥3 kg) | 0 | 0 | 0 | 2 (22) |
a
Reported as number(percentage) unless otherwise indicated.
b
Attenuated challenge. P values were 0.166 for subjects shedding the challenge strain and subjects with any diarrhea.
c
Fully virulent challenge. P values were 0.001, 0.000, and 0.171 for subjects shedding the challenge strain subjects with any diarrhea, and subjects with severe or moderate diarrhea, respectively.
d
Values were determined only for subjects who shed the challenge agents.