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Human Challenge Model With ST-only Enterotoxigenic Escherichia Coli

NCT02870751 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-09-11

No results posted yet for this study

Summary

Heat stable toxin (ST) producing ETEC strains are important causes of childhood diarrhea in many countries. Vaccine candidates targeting ST are in development. A human challenge model using an epidemiologically relevant enterotoxigenic E.coli (ETEC) strain expressing ST, but not other diarrhea inducing toxins like heat labile toxin (LT), is necessary to perform an early and efficient evaluation of an ST-toxoid based vaccine.

In this controlled human infection study the investigators will assess the safety of a ST-only producing ETEC strain and the dose needed to achieve an attack rate of 70% in healthy human volunteers.

Conditions

  • Diarrhea, Infantile

Interventions

BIOLOGICAL

TW11681 or TW10722

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • University of Bergen

    lead OTHER

Principal Investigators

  • Halvor Sommerfelt, MD, PhD · Centre for International Health, University of Bergen

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-12-31
Completion
2019-09-30

Countries

  • Norway

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 NCT02870751 on ClinicalTrials.gov