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OpenTrials
Completed

NCT Number: NCT03998449

Immunogenicity of Cholera Vaccine in Children With IBD

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

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Key information

Conditions

Cholera Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Gram-Negative Bacterial Infections Infections Inflammatory Bowel Diseases Intestinal Diseases Vibrio Infections

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw

Warsaw, 02-091, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaccination against cholera

Biological

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

Primary outcomes

  1. Achieving seroprotective antibody concentration

    Time frame: 4-6 weeks after the second dose

    Serum antibody concentration indicating protection against cholera.

Secondary outcomes

  1. Adverse effects

    Time frame: 3 days after each dose

    Evaluation of adverse effects after vaccination.

  2. Inflammatory bowel disease exacerbation occurrence.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Medical University of Gdansk

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2019
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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