Shigella WRSS1 Vaccine Trial in Bangladesh

Status Completed

Clinical Trial Summary

This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response. Shigella causes bloody and watery diarrhea, and infants and children living in developing countries experience the greatest consequences of this disease.

Clinical Trial Description

The WRSS1 vaccine in will be given to healthy toddlers (12-24 months old). The first vaccination was given to toddlers in the inpatient unit and the second and third doses will be administered on an outpatient basis. A safety evaluation was performed after the first dose before enrolling subjects in subsequent cohorts to receive a higher vaccine dose.

After the study was initiated, its funder, the Bill and Melinda Gates Foundation (BMGF) made significant changes to the PATH Enteric Vaccine Initiative (EVI) portfolio and decided not to support the three higher-dose cohorts (Cohort 1, 2, and 3) planned as part of this study. ;

Study Design

Related Conditions & MeSH terms

Diarrhea

Clinical Trial Details

NCT number	NCT02934178
Study type	Interventional
Source	PATH
Contact
Status	Completed
Phase	Phase 1
Start date	February 23, 2017
Completion date	January 10, 2018

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