Immunogenicity of Cholera Vaccine in Children With IBD

Medical University of Warsaw80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cholera Inflammatory Bowel Diseases

Interventions

Vaccination against choleraBIOLOGICAL

Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of Warsaw

Warsaw, Poland

Outcomes

Primary Outcomes

Achieving seroprotective antibody concentration

Serum antibody concentration indicating protection against cholera.

Time frame: 4-6 weeks after the second dose

Secondary Outcomes

Adverse effects

Evaluation of adverse effects after vaccination.

Time frame: 3 days after each dose

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.

Time frame: 4-6 weeks after the second dose

Data from ClinicalTrials.gov

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