Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

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

Official Title
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Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease

Conditions
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Diphtheria, Inflammatory Bowel Diseases

Intervention / Treatment
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* Biological: Diphtheria booster vaccination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diphtheria booster vaccination<br>One booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis | Biological: Diphtheria booster vaccination<br>* Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Booster response | 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. | after 4-8 weeks | 
| Adverse effects | Evaluation of adverse effects after vaccination. | 3 days | 
| 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. | after 4-8 weeks |