Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections

July 8, 2012 updated by: Hillel Yaffe Medical Center
The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study humoral and cellular immune parameters following natural infections with Shigella and ETEC, and to compare the level of pre-existing local, humoral and cellular immune parameters in cases of shigellosis and ETEC-associated diarrhea and in matched controls.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Emek Medical Center
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center
      • Haifa, Israel, 34362
        • Lady Davis Carmel Medical Center
      • Holon, Israel, 58100
        • Edith Wolfson Medical Center
      • Netanya, Israel, 42150
        • Sansz Medical Center - Laniado Hospital
      • Petach Tikva, Israel, 49202
        • Schneider Children's Medical Center
    • Elad
      • Petach Tikvah, Elad, Israel, 40800
        • Leumit Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lab-confirmed Shigella or ETEC
  • Individuals or patients without diarrheal disease

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diarrheal disease
Other: Laboratory Tests
Stool, blood, urine and saliva samples
Active Comparator: Control
Samples of stool, blood, urine saliva
Other: Laboratory Tests
Stool, blood, urine and saliva samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of cases of shigellosis and ETEC-associated diarrhea
Time Frame: Four years
Stool of patients examined in laboratory and identified as infected with the pathogens
Four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Collaborators

European Commission

Investigators

  • Study Director: Daniel Cohen, MPH, PhD, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

July 8, 2012

First Submitted That Met QC Criteria

July 8, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 8, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0105-11-HYMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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