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Safety Study of Recombinant Vaccine to Prevent ETEC Diarrhea

NCT01382095 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-27

No results posted yet for this study

Summary

The purpose of the study is to determine if immunization with a recombinant E. coli protein, dscCfaE, is safe and immunogenic when administered through the skin using a patch.

Conditions

  • Escherichia Coli Infection

Interventions

BIOLOGICAL

Recombinant fimbrial adhesin dscCfaE

10 ug on study days 0, 21 and 42

BIOLOGICAL

Recombinant fimbrial adhesin dscCfaE

50 ug on study days 0, 21 and 42

BIOLOGICAL

Recombinant fimbrial adhesin dscCfaE

250 ug on study days 0, 21 and 42

BIOLOGICAL

Modified E. coli heat labile enterotoxin LTR192G

50 ug on study days 0, 21 and 42

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Mark S. Riddle, MD, DrPH · 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
2011-07-31
Primary Completion
2012-08-31
Completion
2013-04-30

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 NCT01382095 on ClinicalTrials.gov