Immunogenicity of Cholera Vaccine in Children With IBD

May 19, 2020 updated by: Lukasz Dembinski, Medical University of Warsaw

Evaluation of Immunogenicity of Cholera Vaccine in Children With Inflammatory Bowel Disease

Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-091
        • Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
  • no vaccination against cholera in the past,
  • written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion Criteria:

  • serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) > 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) > 40 points for patients with Crohn's disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cholera vaccination
Two doses of the vaccine against cholera
Biological: Vaccination against cholera
Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achieving seroprotective antibody concentration
Time Frame: 4-6 weeks after the second dose
Serum antibody concentration indicating protection against cholera.
4-6 weeks after the second dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 3 days after each dose
Evaluation of adverse effects after vaccination.
3 days after each dose
Inflammatory bowel disease exacerbation occurrence.
Time Frame: 4-6 weeks after the second dose
Disease exacerbation assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease.
4-6 weeks after the second dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Medical University of Gdansk

Investigators

  • Study Director: Aleksandra Banaszkiewicz, MD, PhD, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2017

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dembinski2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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