Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A (NCT02773446) | Clinical Trial Compass
CompletedNot Applicable
Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A
United States47 participantsStarted 2016-04
Plain-language summary
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.
Who can participate
Age range18 Years ā 50 Years
SexALL
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Inclusion criteria
ā. Male or female between 18 and 50 years of age, inclusive.
ā. General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of the PI.
ā. Completion of a training session and demonstration of comprehension of the protocol procedures and knowledge of ETEC-associated illness by passing a written examination.
ā. Willingness to participate after informed consent obtained.
ā. Availability for the study duration, including all planned follow-up visits.
ā. Negative pregnancy test with understanding to not become pregnant during the study or within three months following last scheduled study visit.
Exclusion criteria
ā. Presence of a significant medical condition which in the opinion of the investigator precludes participation in the study.
ā. Significant abnormalities in screening hematology or serum chemistry as determined by PI or PI in consultation with the research monitor and sponsor.
ā. Evidence of confirmed infection with HIV, Hepatitis B, or Hepatitis C.
ā. Evidence of Immunoglobulin A (IgA) deficiency (serum IgA \< 7 mg/dL or below the limit of detection of assay).
ā. Evidence of current excessive alcohol consumption or drug dependence (a targeted drug screen may be used to evaluate at the clinician's discretion).
What they're measuring
1
Number of Participants With Safety- Solicited Symptoms Related to Challenge Administration
Timeframe: 6 days post-challenge
2
Moderate-severe Diarrhea
Timeframe: 5 days post challenge (Cohort 1 and Cohort 2 group B) 7 days post challenge (Cohort 2 Group A)
3
Moderate-severe Diarrhea in Subjects Receiving Homologous Rechallenge
Timeframe: 7 days post-challenge
4
Number of Participants With Safety -Solicited Symptoms Unrelated to Challenge Administration
Timeframe: 6 days post-challenge
Trial details
NCT IDNCT02773446
SponsorJohns Hopkins Bloomberg School of Public Health
ā. Recent vaccination or receipt of an investigational product (within 30 days before receipt of challenge).
ā. 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.