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Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

Primary Purpose

Diphtheria, Inflammatory Bowel Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diphtheria booster vaccination
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diphtheria booster vaccination

    Arm Description

    One booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Adverse effects
    Evaluation of adverse effects after vaccination.
    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.

    Full Information

    First Posted
    June 21, 2019
    Last Updated
    June 21, 2019
    Sponsor
    Medical University of Warsaw
    Collaborators
    Wroclaw Medical University, Poznan University of Medical Sciences, Medical University of Silesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03998215
    Brief Title
    Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease
    Official Title
    Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2012 (Actual)
    Primary Completion Date
    January 1, 2015 (Actual)
    Study Completion Date
    January 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Warsaw
    Collaborators
    Wroclaw Medical University, Poznan University of Medical Sciences, Medical University of Silesia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diphtheria, Inflammatory Bowel Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diphtheria booster vaccination
    Arm Type
    Experimental
    Arm Description
    One booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis
    Intervention Type
    Biological
    Intervention Name(s)
    Diphtheria booster vaccination
    Intervention Description
    Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis
    Primary Outcome Measure Information:
    Title
    Achieving seroprotective antibody concentration
    Description
    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 Outcome Measure Information:
    Title
    Booster response
    Description
    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
    Title
    Adverse effects
    Description
    Evaluation of adverse effects after vaccination.
    Time Frame
    3 days
    Title
    Inflammatory bowel disease exacerbation occurrence.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aleksandra Banaszkiewicz, MD, PhD
    Organizational Affiliation
    Medical University of Warsaw
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32032309
    Citation
    Dembinski L, Krzesiek E, Klincewicz B, Grzybowska-Chlebowczyk U, Demkow U, Banaszkiewicz A, Radzikowski A. Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease. Pediatr Infect Dis J. 2020 Mar;39(3):244-246. doi: 10.1097/INF.0000000000002547.
    Results Reference
    derived

    Learn more about this trial

    Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

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