NCT01524640

Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

A Randomized, Double-blind, Controlled Trial to Evaluate the Safety and Immunogenicity of Killed Bivalent (o1 and o139) Whole-cell Based Oral Cholera Vaccine (Shanchol®) in Healthy Individuals in Ethiopia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.

Detailed description

This study serves as a bridging trial to evaluate the safety and immunogenicity of a two dose regimen of the WC-OCV (Shanchol®) in Ethiopian population. In order to assess whether the bivalent killed oral cholera vaccine may be used safely among those who are most at risk for cholera, we need to determine the safety and immunogenicity of the killed oral cholera vaccine. The vaccine was evaluated in a large number of human subjects in India Vietnam, and Bangladesh, in which it has demonstrated safety, immunogenicity, and clinical protective efficacy. Though we do not expect the vaccine to act differently in the Ethiopian population, we aim to confirm our presumptive understanding that two doses of WC-OCV is safe and immunogenic in healthy volunteers at one year and above (exclusive of pregnant women). Findings from this study can pave the way for the possible use of the killed whole cell oral cholera vaccine in both endemic and outbreak settings at a larger scale.

Conditions

• Vibrio Cholerae
• Cholera

Interventions

Type	Name	Description
BIOLOGICAL	Killed Bivalent (O1 and O139) whole cell oral cholera vaccine	1.5 ml single dose oral administration on day 0 and day 14
BIOLOGICAL	Placebo	1.5 ml oral administration on day 0 and day 14

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-02-02
• Last updated: 2015-05-04

Locations

1 site across 1 country: Ethiopia