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
About this trial
This is an interventional prevention trial for Cholera
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.
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
NCT ID
NCT03998449
First Posted
June 24, 2019
Last Updated
May 19, 2020
Sponsor
Medical University of Warsaw
Collaborators
Medical University of Gdansk
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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