NCT02934178

Shigella WRSS1 Vaccine Trial in Bangladesh

A Phase 1 Randomized, Double-Blinded, Placebo-controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Live Attenuated, Oral Shigella WRSS1 Vaccine in Bangladeshi Toddlers (12 to 24 Months Old)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Shigella sonnei Strain WRSS1 Vaccine	Live attenuated, oral Shigella WRSS1 vaccine
BIOLOGICAL	Placebo	Sterile saline solution

Timeline

• Start date: 2017-02-23
• Primary completion: 2018-01-10
• Completion: 2018-01-10
• First posted: 2016-10-14
• Last updated: 2020-03-31
• Results posted: 2020-03-31

Locations

1 site across 1 country: Bangladesh

Regulatory

• FDA-regulated drug study