TABLE 1.
Clinical outcome | % of: |
||||
---|---|---|---|---|---|
Naïve subjects who receiveda: |
Veteransa |
||||
105 CFU (n = 5) | 107 CFU (n = 5) | 109 CFU (n = 36) | STV (n = 8) | LTV (n = 7) | |
Infectionb | 100 | 100 | 100 | 75 | 100 |
Campylobacteriosisc | |||||
Met primary endpoint | 60 | 40 | 92 | 0d | 57 |
Mild illness | 0 | 20 | 25 | 0 | 14 |
Moderate illness | 20 | 0 | 22 | 0 | 29 |
Severe illness | 40 | 20 | 45 | 0 | 14 |
Associated symptoms | |||||
Fever | 60 | 0 | 44 | 0 | 14 |
Abdominal cramps | 60 | 60 | 83 | 25 | 86 |
Nausea | 40 | 40 | 50 | 25 | 57 |
Vomiting | 20 | 0 | 14 | 0 | 14 |
Dysentery | 40 | 20 | 11 | 0 | 0 |
Hemoccult | 60 | 40 | 56 | 0 | 43 |
Fecal leukocytese | 75 | 67 | 31 | 25 | 14 |
Groups were defined based on exposure to C. jejuni 81-176, as follows: naïve subjects, one exposure to C. jejuni; and veterans (STV and LTV), two exposures to C. jejuni. The STV and LTV groups are described in Materials and Methods. For veterans the clinical outcomes after the initial exposure were as follows: for the STV group, one subject with mild campylobacteriosis, three subjects with moderate campylobacteriosis, and four subjects with severe campylobacteriosis; and for the LTV group, three subjects that did not meet the clinical endpoint (after the initial exposure, two subjects with moderate campylobacteriosis and one subject who was not ill) and four subjects with campylobacteriosis (after the initial exposure, one subject who was not ill and three subjects with severe campylobacteriosis).
Infection was defined as two consecutive stool cultures that were positive for C. jejuni at ≥24 h postinoculation.
The levels of campylobacteriosis were defined as follows (all required documentation of infection). Mild campylobacteriosis was defined as 3 to 9 loose or liquid stools per 24 h or ≥2 loose stools per 24 h consisting of ≥300 ml. Moderate campylobacteriosis was defined as two of the following: diarrhea, oral temperature of ≥38.1°C, and moderate or severe gastrointestinal signs or symptoms (abdominal cramps, nausea, vomiting, tenesmus, and gross blood in stools). Severe campylobacteriosis was defined as any two of the following plus infection: high fever (oral temperature, >38.6°C), diarrhea (>9 stools), >1 severe associated symptom, and dysenteric stools (gross blood in two specimens).
The campylobacteriosis attack rates were different for the veteran groups (P = 0.03, Fisher's exact test).
The numbers of subjects tested for fecal leukocytes were as follows: 4 subjects who received 105 CFU, 3 subjects who received 107 CFU, all naïve subjects who received 109 CFU, and all subjects in the veteran groups.