Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

Medical University of Warsaw46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Diphtheria Inflammatory Bowel Diseases

Interventions

Diphtheria booster vaccinationBIOLOGICAL

Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: after 4-8 weeks

Secondary Outcomes

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.

Time frame: after 4-8 weeks

Adverse effects

Evaluation of adverse effects after vaccination.

Time frame: 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.

Time frame: after 4-8 weeks

Data from ClinicalTrials.gov

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