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Challenge Study of an ETEC Vaccine

NCT01922856 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-07-06

No results posted yet for this study

Summary

The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.

Conditions

  • Enteritis; Escherichia Coli, Enterotoxigenic

Interventions

BIOLOGICAL

LTR192G with dscCfaE

Recombinant fimbrial adhesin (dscCfaE) with Modified Escherichia coli (E coli) heat labile enterotoxin (LTR192G)

OTHER

No Intervention

Controls only receive challenge

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Kawsar Talaat, MD · Johns Hopkins Center for Immunization Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-19
Primary Completion
2016-02-06
Completion
2016-07-14

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 NCT01922856 on ClinicalTrials.gov