TABLE 3.
Clinical tolerance of oral inactivated whole-cell vaccine plus adjuvant by study group
| Symptom | No. of subjects
|
||||||||
|---|---|---|---|---|---|---|---|---|---|
|
H. pylori uninfected (unblinded dose response at:)
|
H. pylori infected
|
||||||||
| Unblinded dose response at:
|
Randomized assignment at:
|
||||||||
| 106, 25 μg (n = 3)a | 108, 25 μg (n = 4) | 1010, 25 μg (n = 10) | 106, 25 μg (n = 3) | 108, 25 μg (n = 3) | 1010, 0 (n = 2) | 0, 25 μg (n = 3) | 0, 0 (n = 5) | 1010, 25 μg (n = 8) | |
| Nausea | 1 | 2 | 2 | 1 | 0 | 1 | 1 | 2 | 3 |
| Vomiting | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Anorexia | 1 | 2 | 1 | 1 | 0 | 0 | 1 | 1 | 1 |
| Malaise | 2 | 0 | 3 | 1 | 0 | 1 | 1 | 2 | 3 |
| Heartburn | 1 | 2 | 1 | 2 | 1 | 0 | 1 | 1 | 2 |
| Stomachache | 1 | 1 | 3 | 2 | 0 | 0 | 1 | 3 | 3 |
| Abdominal pain | 0 | 1 | 4 | 3 | 0 | 0 | 1 | 2 | 2 |
| Fever of >100°F | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 |
| Diarrheab | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 2 |
| Blood in stool | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
a
Each study design is presented as follows: HWC dose, LTR192G dose (n = number of subjects). The actual doses of HWC were 2.5 × 106, 2.5 × 108, or 2.5 × 1010.
b
Defined as three or more loose or watery stools within a 24-h period.