Low-dose Challenge Model With Enterotoxigenic E Coli

This is an interventional prevention trial for Diarrhea focused on measuring diarrhea, vaccine, enterotoxigenic E coli, colonization factor antigen, volunteer study Read More

Inclusion Criteria:

1. Male or female between 18 and 45 years of age, inclusive.
2. General good health, as determined by physical exam, laboratory testing, and medical history.
3. Laboratory values within acceptable range for complete blood count (CBC), Alanine Aminotransferase (ALT), and serum creatinine as determined by PI.
4. Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade ≥ 70%)
5. Able and willing to sign an informed consent.
6. Available to participate for the length of the study.
7. Female only: Females of childbearing potential will use an effective method of contraception during the study, including abstinence, hormonal contraception, barrier, implantables or injectables.

Exclusion Criteria:

1. Presence of a clinically significant medical condition (including but not limited to any chronic illnesses, immunosuppressive illness, cancer, diabetes, gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease)
2. Evidence of immunoglobulin A (IgA) deficiency (serum IgA <5 or limit of detection of assay)
3. Evidence of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), by medical history or laboratory testing.
4. Symptoms consistent with Traveler's Diarrhea concurrent with travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to receipt of investigational agent, OR planned travel to endemic countries during the length of the trial.
5. History of significant psychiatric illness requiring hospitalization or any suicide attempts within the past 2 years.
6. History of significant drug or alcohol abuse requiring hospitalization or rehabilitation within the past 2 years.
7. Evidence of significant drug abuse, as determined by the Principal Investigator, on toxicity screening.
8. 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.
9. History of allergic reaction to fluoroquinolones, cotrimoxazole, or ampicillin/penicillin (excluded if allergic to two of three).
10. History of diarrhea in the 2 weeks prior to receipt of investigational agent.
11. Weekly use of laxatives or any agent that increases gastric pH.
12. Use of antibiotics during the 7 days prior to receipt of investigational agent.
13. Use of proton pump inhibitors, H2 blockers, or antacids within 48 hours of receipt of investigational agent.
14. History of vaccination for or ingestion of ETEC, cholera, or heat labile toxin (LT) toxin within 5 years.*
15. History of participation in prior ETEC H10407 research studies.*
16. Use of any other investigational product within 30 days preceding the receipt of investigational agent, or planned use during the active study period.
17. Use of any medication known to affect the immune function (e.g., corticosteroids) within 30 days preceding receipt of investigational agent or planned use during the active study period. (Topical and intra-articular steroids will not exclude subjects).
18. Any other condition, which in the opinion of the investigator, could affect subject safety or interfere with the trial.