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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Dysentery

Treatments: Other: Laboratory Tests

Study type: Interventional

Funder types: Other

Identifiers

NCT01638039

0105-11-HYMC

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• n/a

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

Diarrheal disease

Active Comparator group

Treatment:

Other: Laboratory Tests

Control

Active Comparator group

Description:

Samples of stool, blood, urine saliva

Treatment:

Other: Laboratory Tests