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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.