Campylobacter Jejuni Challenge Model Development: Assessment of Homologous Protection

This is an interventional prevention trial for Campylobacter Infections focused on measuring campylobacter, gastroenteritis, challenge models Read More

Inclusion Criteria:

• Male or female between 18 and 50 years of age, inclusive.
• General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator or principal investigator in consultation with the medical monitor and sponsor.
• Demonstrate comprehension of the protocol procedures and knowledge of Campylobacter illness by passing a written examination (pass grade ≥ 70%)
• Willing to participate after informed consent obtained.
• Available for all planned follow-up visits, and remain available for medical interview/physical exam and monitoring for 90 days post-challenge (last challenge received), and a final telephone interview 180 days post-challenge.
• Negative urine pregnancy test at screening and a negative urine pregnancy test on the day of admittance to the inpatient phase for all female subjects. In addition, female subjects will be advised of the need for an effective means of birth control during the entire study period.

Exclusion Criteria:

• Presence of a significant medical condition (e.g., psychiatric conditions; gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis, inflammatory bowel disease, irritable bowel syndrome; alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study.
• Immunosuppressive illness, IgA deficiency (below the normal limits), or H2 antihistamine use within 48 h of admission or during inpatient period.
• Positive serology results for HIV, HBsAg, or HCV antibodies.
• Significant abnormalities in screening lab hematology, serum chemistry, as determined by PI or PI in consultation with the medical monitor and sponsor.
• Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding receipt of the challenge inoculum or planned use during the active study period.
• Nursing mother on the day of admittance to the inpatient phase for all female subjects.
• Are not capable of fully informed consent (e.g., cannot read or write English)
• Personal or documented family history of an inflammatory arthritis such as reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, or Guillain-Barré syndrome (would not include osteoarthritis or vague history of arthritis in a relative late in adulthood).
• Evidence of neurologic abnormalities (specifically extremity weakness, abnormal deep tendon reflexes, symmetric sensory abnormalities - vibratory, light touch, and proprioception).
• Evidence of inflammatory arthritis on exam and/or HLA-B27 positive (flow cytometry).
• Allergy or prior intolerance to any of the following antibiotics: azithromycin, fluoroquinolones, or penicillin.
• Fewer than 3 stools per week or more than 3 stools per day as the usual frequency, loose or liquid stools other than on an occasional basis.
• Regular use of laxatives or any agent that increases gastric pH (regular defined as at least weekly).
• Have household contacts who are <2 years old or >80 years old or infirmed or immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease).
• Employment as either a health care worker with direct patient care, in a daycare center (for children or the elderly), or working directly with food.
• History of microbiologically confirmed Campylobacter infection
• Immunologic evidence of Campylobacter exposure
• Individuals who have traveled to countries with high Campylobacter rates within the past two years and who experienced an episode of diarrhea during or within 1 week of returning from their trip.
• And others