Immunogenicity of Cholera Vaccine in Children With IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

Evaluation of Immunogenicity of Cholera Vaccine in Children With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998449
• Other study ID #: Dembinski2019
• Status: Completed
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholera
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Biological:
• Vaccination against cholera
Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieving seroprotective antibody concentration	Serum antibody concentration indicating protection against cholera.	4-6 weeks after the second dose
Secondary	Adverse effects	Evaluation of adverse effects after vaccination.	3 days after each dose
Secondary	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.	4-6 weeks after the second dose