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Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea

NCT01644565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-02-12

Study results available
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Summary

The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.

Conditions

  • Escherichia Coli Infection

Interventions

BIOLOGICAL

Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5

BIOLOGICAL

Recombinant fimbrial adhesin dscCfaE

BIOLOGICAL

Modified E. coli heat labile enterotoxin LTR192G

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Ramiro L. Gutierrez, MD, MPH · Enteric Diseases Department, Naval Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-06-30
Completion
2015-06-30

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 NCT01644565 on ClinicalTrials.gov