Immunogenicity of Cholera Vaccine in Children With IBD

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Cholera
• Interventions: Biological: Vaccination against cholera

• Registration Number: NCT03998449
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-30
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Primary Completion: 2020-04-01
• Status Verified: 2020-05
• Study Completion: 2020-05-01
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cholera vaccination	Vaccination against cholera	Two doses of the vaccine against cholera

Primary Outcome Measures

Name	Time	Method
Achieving seroprotective antibody concentration	4-6 weeks after the second dose	Serum antibody concentration indicating protection against cholera.

Secondary Outcome Measures

Name	Time	Method
Inflammatory bowel disease exacerbation occurrence.	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.
Adverse effects	3 days after each dose	Evaluation of adverse effects after vaccination.

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Poland