Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A

Completed · Not applicable

Conditions studied: Healthy Volunteer

In brief

The purpose of this study is to determine the safe and optimal dose and regimen (fasting duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain. Additionally, an assessment of homologous protection following rechallenge with B7A will be assessed.

Key facts

Study ID

NCT02773446

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

47

Starts

2016-04-01

Expected to finish

2016-12-01

Last updated by the study team

2018-07-06

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between 18 and 50 years of age, inclusive.
• General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of the PI.
• Completion of a training session and demonstration of comprehension of the protocol procedures and knowledge of ETEC-associated illness by passing a written examination.
• Willingness to participate after informed consent obtained.
• Availability for the study duration, including all planned follow-up visits.
• Negative pregnancy test with understanding to not become pregnant during the study or within three months following last scheduled study visit.

You may not qualify if…

• Presence of a significant medical condition which in the opinion of the investigator precludes participation in the study.
• Significant abnormalities in screening hematology or serum chemistry as determined by PI or PI in consultation with the research monitor and sponsor.
• Evidence of confirmed infection with HIV, Hepatitis B, or Hepatitis C.
• Evidence of Immunoglobulin A (IgA) deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay).
• Evidence of current excessive alcohol consumption or drug dependence (a targeted drug screen may be used to evaluate at the clinician's discretion).
• Evidence of impaired immune function.
• Recent vaccination or receipt of an investigational product (within 30 days before receipt of challenge).
• 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.
• History of microbiologically confirmed ETEC or cholera infection in last 3 years.
• Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years.
• Symptoms consistent with Travelers' Diarrhea concurrent with travel or planned travel to countries where ETEC infection is endemic.
• Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to dosing.
• Any prior experimental infection with ETEC strain B7A.
• Abnormal stool pattern.
• Regular use of laxatives, antacids, or other agents to lower stomach acidity.
• Use of any medication known to affect the immune function.
• Known allergy to two of the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and amoxicillin.

Where it is running

• Johns Hopkins Center for Immunization Research — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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