Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998215
• Other study ID #: Dembinski2012
• Status: Completed
• Phase: N/A
• Start date: December 1, 2012
• Est. completion date: January 1, 2015

Study information

• Verified date: June 2019
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 1, 2015
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diphtheria
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Biological:
• Diphtheria booster vaccination
Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of Warsaw	Medical University of Silesia, Poznan University of Medical Sciences, Wroclaw Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse effects	Evaluation of adverse effects after vaccination.	3 days
Secondary	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