Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose

Inclusion Criteria

• Healthy adults between 18 and 50 years of age, inclusive, at the time of signing the informed consent.
• General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI.
• Negative pregnancy test at screening and prior to challenge for people of childbearing potential. People of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. People of childbearing potential unable to bear children must have this documented (e.g. tubal ligation or hysterectomy) or must have negative pregnancy tests at screening and prior to challenge.
• Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
• Completion of a training session and demonstrated comprehension of the protocol procedures and knowledge of ETEC associated illness by passing a written examination (70% pass score).
• Availability for the study duration, including planned follow-up visit/contact.

Exclusion Criteria

• Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study, including gastrointestinal disease (gastritis, irritable bowel disease as suggested by Rome III criteria or medical diagnosis, inflammatory bowel disease). Some medical conditions which are adequately treated and stable would not preclude entry into the study. These conditions might include stable asthma controlled with inhalers or mild hypertension stably controlled.
• Significant abnormalities in screening haematology, or serum chemistry as determined by PI.
• Presence in the serum of HIV antibody, HBsAg, or HCV antibody with confirmation of infection (e.g. by HCV PCR).
• Evidence of IgA deficiency (serum IgA two months in ETEC endemic countries during the last 10 years, OR planned travel to endemic countries prior to study day 180.
• Vaccination for or ingestion of ETEC, cholera, or LT toxin within 5 years prior to dosing.
• Use of antibiotics during the 14 days before challenge dosing or proton pump inhibitors, H2 blockers or antacids within 48 hours prior to challenge dosing.
• History of diarrhea in the 7 days prior to challenge (outpatient diarrhea is defined as ≥ 3 unformed (grade 3 or greater) loose stools in 24 hours).
• Known allergy to two of the three following antibiotics: ciprofloxacin, amoxicillin, and/or azithromycin.