Table 2.
Clinical Illness and Serologic Response in Subjects Challenged With CS17- and CS19-ETEC Strains
| Strain | CF type | Dose (cfu) | N | Subjects with diarrhea, % | Time to meeting definition of diarrhea in he | Diarrhea output (g)a |
Other gastrointestinal signs/symptoms, % |
Anti-CF antibody seroconversion, %b |
Anti-LT antibody seroconversion, % |
|||||
| Total | Max. 24 h | Abdominal cramps | Vomiting | Nausea | IgG | IgA | IgG | IgA | ||||||
| LSN03-016011/A | CS17 | 7×108 | 5 | 60 | 14 (7, 25) | 787 (384, 1139) | 556 (326, 845) | 80 | 40 | 40 | 60 | 100 | 80 | 80 |
| 6×109 | 8 | 88 | 14 (12, 15) | 1001 (517, 1429) | 508 (429, 717) | 75 | 37 | 25 | 75 | 75 | 100 | 100 | ||
| WS0115A | CS19 | 4×108 | 5 | 20 | 17 | 1186 | 1186 | 40 | 0 | 20 | 40 | 60 | 60 | 60 |
| 3×109 | 6 | 33 | 24 (23, 25) | 677 (402, 951) | 449 (402, 495) | 50 | 0 | 33 | 33 | 83 | 50 | 50 | ||
| 9×109 | 9 | 44 | 64 (26, 102) | 692 (461, 919) | 462 (407, 549) | 22 | 0 | 11 | 44 | 100 | 44 | 55 | ||
| DS26-1 | CS19 | 4×108 | 5 | 0 | n/a | 0 | 0 | 0 | 0 | 0 | 0 | 40 | 20 | 40 |
a
Median (interquartile range) calculated for subjects who met the study definition of diarrhea. “Total” is the total output of loose stools during the study period, and “max. 24 h” is the maximum output of loose stools in any 24-hour period.
b
% of subjects with ≥ 4-fold increase in anti-CS17 antibody among those challenged with LSN03-016011/A or anti-CS19 antibody among those challenged with WS0115A or DS26-1.