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Immunogenicity of Cholera Vaccine in Children With IBD

Primary Purpose

Cholera, Inflammatory Bowel Diseases

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Vaccination against cholera
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholera

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Warsaw

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cholera vaccination

Arm Description

Two doses of the vaccine against cholera

Outcomes

Primary Outcome Measures

Achieving seroprotective antibody concentration
Serum antibody concentration indicating protection against cholera.

Secondary Outcome Measures

Adverse effects
Evaluation of adverse effects after vaccination.
Inflammatory bowel disease exacerbation occurrence.
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.

Full Information

First Posted
June 24, 2019
Last Updated
May 19, 2020
Sponsor
Medical University of Warsaw
Collaborators
Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT03998449
Brief Title
Immunogenicity of Cholera Vaccine in Children With IBD
Official Title
Evaluation of Immunogenicity of Cholera Vaccine in Children With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
Collaborators
Medical University of Gdansk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera, Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholera vaccination
Arm Type
Experimental
Arm Description
Two doses of the vaccine against cholera
Intervention Type
Biological
Intervention Name(s)
Vaccination against cholera
Intervention Description
Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.
Primary Outcome Measure Information:
Title
Achieving seroprotective antibody concentration
Description
Serum antibody concentration indicating protection against cholera.
Time Frame
4-6 weeks after the second dose
Secondary Outcome Measure Information:
Title
Adverse effects
Description
Evaluation of adverse effects after vaccination.
Time Frame
3 days after each dose
Title
Inflammatory bowel disease exacerbation occurrence.
Description
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.
Time Frame
4-6 weeks after the second dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Banaszkiewicz, MD, PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-091
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Immunogenicity of Cholera Vaccine in Children With IBD

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