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

Not Applicable

• Conditions: Dysentery
• Interventions: Other: Laboratory Tests

• Registration Number: NCT01638039
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-08
• Study First Submitted QC: 2012-07-08
• Last Update Submitted: 2012-07-08
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

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

Exclusion Criteria

• n/a

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diarrheal disease	Laboratory Tests	-
Control	Laboratory Tests	Samples of stool, blood, urine saliva

Primary Outcome Measures

Name	Time	Method
Identification of cases of shigellosis and ETEC-associated diarrhea	Four years	Stool of patients examined in laboratory and identified as infected with the pathogens

Trial Locations

Locations (7)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel

Emek Medical Center; 🇮🇱 Afula, Israel

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel

Leumit Health Care System; 🇮🇱 Petach Tikvah, Elad, Israel

Lady Davis Carmel Medical Center; 🇮🇱 Haifa, Israel

Sansz Medical Center - Laniado Hospital; 🇮🇱 Netanya, Israel

Schneider Children's Medical Center; 🇮🇱 Petach Tikva, Israel