MedTrace Logo

Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A

NCT02773446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2018-07-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy Volunteer

Interventions

BIOLOGICAL

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer

ETEC Bacteria

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • PATH

    collaborator OTHER

  • Naval Medical Research Center

    collaborator FED

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Kawsar R. Talaat, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02773446 on ClinicalTrials.gov