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

NCT ID: NCT01638039

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dysentery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diarrheal disease

Group Type ACTIVE_COMPARATOR

Laboratory Tests

Intervention Type OTHER

Stool, blood, urine and saliva samples

Control

Samples of stool, blood, urine saliva

Group Type ACTIVE_COMPARATOR

Laboratory Tests

Intervention Type OTHER

Stool, blood, urine and saliva samples

Interventions

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Laboratory Tests

Stool, blood, urine and saliva samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* n/a
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Cohen, MPH, PhD

Role: STUDY_DIRECTOR

School of Public Health, Sackler Faculty of Medicine, Tel Aviv University

Locations

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Leumit Health Care System

Petach Tikvah, Elad, Israel

Site Status

Emek Medical Center

Afula, , Israel

Site Status

Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Lady Davis Carmel Medical Center

Haifa, , Israel

Site Status

Edith Wolfson Medical Center

Holon, , Israel

Site Status

Sansz Medical Center - Laniado Hospital

Netanya, , Israel

Site Status

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Amit Hochberg, MD

Role: primary

Moshe Efrat, MD

Role: primary

Uri Rubinstein, MD

Role: primary

Shai Ashkenazi, MD

Role: primary

Other Identifiers

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0105-11-HYMC

Identifier Type: -

Identifier Source: org_study_id