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Completed

NCT Number: NCT03998215

Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

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

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Corynebacterium Infections Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Inflammatory Bowel Diseases Intestinal Diseases

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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),
  • 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.

Treatment and study plan

Diphtheria booster vaccination

Biological

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

Primary outcomes

  1. Achieving seroprotective antibody concentration

    Time frame: 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 outcomes

  1. Booster response

    Time frame: 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.

  2. Adverse effects

    Time frame: 3 days

    Evaluation of adverse effects after vaccination.

  3. Inflammatory bowel disease exacerbation occurrence.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Medical University of Silesia
  • Poznan University of Medical Sciences
  • Wroclaw Medical University

Registry information

Official study title

Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2019
Registry last updated
Jun 26, 2019

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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