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Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose

NCT06290089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-07-18

Study results available
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Summary

This was an open-label, single-site pre-study designed to evaluate the safety, tolerability, and infectivity of wild-type Enterotoxigenic Escherichia coli (ETEC) strain E24377A in healthy adults. The aim was to estimate the incidence of moderate and severe diarrhea following oral challenge with approximately 4 × 10⁹ colony forming units (cfu) of the strain.

A total of 23 participants were enrolled and monitored in an inpatient setting after receiving a single challenge dose. Clinical signs, symptoms, and stool output were assessed over 120 hours. This challenge model was developed to support a future controlled human infection study (CHIM) evaluating an oral inactivated ETEC vaccine.

Conditions

  • ETEC Diarrhea

Interventions

OTHER

Enterotoxigenic E. coli (ETEC) strain

Challenge strain

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • Scandinavian Biopharma AB

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2024-02-17
Completion
2024-09-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06290089 on ClinicalTrials.gov