Table 3.

Clinical tolerance of oral inactivated whole-cell vaccine plus adjuvant by study group

SymptomNo. of subjects
H. pylori uninfected (unblinded dose response at:)H. pylori infected
Unblinded dose response at:Randomized assignment at:
106, 25 μg (n = 3)a108, 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)
Nausea122101123
Vomiting001000001
Anorexia121100111
Malaise203101123
Heartburn121210112
Stomachache113200133
Abdominal pain014300122
Fever of >100°F011100110
Diarrheab 003000102
Blood in stool000000011
  • 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.