Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Diphtheria; Inflammatory Bowel Diseases
• Interventions: Biological: Diphtheria booster vaccination

• Registration Number: NCT03998215
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-01
• Primary Completion: 2015-01-01
• Study Completion: 2015-01-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Study First Posted: 2019-06-26
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
• vaccination, as a part of the basic vaccination course, with five doses of diphtheria, tetanus and whole-cell pertussis vaccine, without booster dose after the age of 6,
• 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
Diphtheria booster vaccination	Diphtheria booster vaccination	One booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis

Primary Outcome Measures

Name	Time	Method
Achieving seroprotective antibody concentration	after 4-8 weeks	Antibody concentrations ≥0.1 IU/ml indicated protection against diphtheria, while levels ≥1.0 IU/ml were considered to ensure long-term protection.

Secondary Outcome Measures

Name	Time	Method
Booster response	after 4-8 weeks	Booster response was defined as a post-vaccination antibody concentration ≥0.4 IU/mL in initially seronegative subjects or as a fourfold increase of antibody concentration in initially seropositive ones.
Adverse effects	3 days	Evaluation of adverse effects after vaccination.
Inflammatory bowel disease exacerbation occurrence.	after 4-8 weeks	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.