Clinical trial NCT06290089: Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose
Official title: Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ETEC Diarrhea
Lead sponsor: Scandinavian Biopharma AB
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins Bloomberg School of Public Health
First posted: 2024-03-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open label study with the aim to estimate the incidence of moderate and severe diarrhea among participants challenged with an enterotoxigenic E. coli (ETEC) strain. This strain is planned to be used in a subsequent challenge study on the efficacy of an oral inactivated ETEC vaccine.

The study will be conducted at one site; the Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, United States.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults between 18 and 50 years of age, inclusive, at the time of signing the informed consent.
2. General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI.
3. 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.
4. Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
5. 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).
6. Availability for the study duration, including planned follow-up visit/contact.

Exclusion Criteria:

1. 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.
2. Significant abnormalities in screening haematology, or serum chemistry as determined by PI.
3. Presence in the serum of HIV antibody, HBsAg, or HCV antibody with confirmation of infection (e.g. by HCV PCR).
4. Evidence of IgA deficiency (serum IgA \< 7 mg/dl or limit of detection of assay).
5. Evidence of current alcohol or drug dependence.
6. Subjects whose Body Mass Index (BMI) is less than 19.0 or greater than 37.0 (kg/m2).
7. Recent vaccination or receipt of an investigational product (within 30 days before challenge) or intended vaccination or receipt of investigational products until 60 days after challenge, with the exception of licensed vaccine for influenza or SARS-CoV-2 vaccination that may be given up to 7 days prior to challenge.
8. Positive test for SARS-CoV-2 at arrival to the unit on the day of in-patient admission.
9. Intention to donate blood or blood products within one month following the completion of study participation (note: The Red Cross will not allow blood donations for 1 year following participation in an investigational research study).
10. Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study, or the results of the study.
11. Abnormal stool pattern (fewer than 3 per week or more than 3 per day).
12. Regular (≥ weekly) use of laxatives, antacids, or other agents to lower stomach acidity.
13. Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding the challenge or planned use during the active study period. Use of inhaled or topical steroids may be permitted per PI discretion.
14. History of microbiologically confirmed ETEC infection in the last 3 years.
15. Occupational handling of ETEC currently, or in the past 3 years.
16. Travel to countries where ETEC infection is endemic (most of the developing world) within two years prior to dosing OR visit for \> two months in ETEC endemic countries during the last 10 years, OR planned travel to endemic countries prior to study day 180.
17. Vaccination for or ingestion of ETEC, cholera, or LT toxin within 5 years prior to dosing.
18. 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.
19. 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).
20. Known allergy to two of the three following antibiotics: ciprofloxacin, amoxicillin, and/or azithromycin.

Primary outcomes:
measure: The incidence of moderate and severe diarrhea
timeFrame: 120 hours post-challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
References: