Immunogenicity of Cholera Vaccine in Children With IBD

Medical University of Warsaw

Status: Completed

Conditions: Cholera; Inflammatory Bowel Diseases

Treatments: Biological: Vaccination against cholera

Study type: Interventional

Funder types: Other

Identifiers

NCT03998449

Dembinski2019

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Cholera vaccination

Experimental group

Description:

Two doses of the vaccine against cholera

Treatment:

Biological: Vaccination against cholera