The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Completed
Phase
Early Phase 1
Locations
Hungary
Study Type
Interventional
Intervention
Influenza vaccine, Immune function
Sponsored by
About this trial
This is an interventional prevention trial for Juvenile Idiopathic Arthritis
Eligibility Criteria
Inclusion Criteria:
- JIA (oligoarticular, polyarticular) treated with MTX or MTX/adalimumab
- Healthy controls
Exclusion Criteria:
- Children with infection
- Children with active JIA disease
- JIA other than oligoarticular, polyarticular type
Sites / Locations
- University of Pécs, Medical School, Department of Paediatrics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
TNF-alpha inhibitor
Methotrexate
Healthy
Arm Description
Outcomes
Primary Outcome Measures
Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab)
Analysing T and B cells (%, /microL) by flow cytometry.
Immune response to influenza vaccine, the rate of seroconversion
Measuring seroconversion after influenza vaccine (IU)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03833271
Brief Title
The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary
Official Title
The Investigation of Immune Function and the Effectiveness of Influenza Vaccine in Children With Juvenile Idiopathic Arthritis Compared to Healthy Control
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 28, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pecs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of our study is to compare the immune function of patient treated with DMARD (methotrexate), or tumor necrosis factor (TNF)-alpha inhibitor (adalimumab) to healthy children. The study consists of three parts. In each part physical examination and routine laboratory tests are done.
At the first examination flow cytometry analysis is performed, after that the participants are immunized with influenza (3Fluart) vaccine. At part two and three further flow cytometry is carried out and seroconversion is measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TNF-alpha inhibitor
Arm Type
Active Comparator
Arm Title
Methotrexate
Arm Type
Active Comparator
Arm Title
Healthy
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine, Immune function
Intervention Description
Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.
Primary Outcome Measure Information:
Title
Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab)
Description
Analysing T and B cells (%, /microL) by flow cytometry.
Time Frame
12-14 weeks
Title
Immune response to influenza vaccine, the rate of seroconversion
Description
Measuring seroconversion after influenza vaccine (IU)
Time Frame
12-14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
JIA (oligoarticular, polyarticular) treated with MTX or MTX/adalimumab
Healthy controls
Exclusion Criteria:
Children with infection
Children with active JIA disease
JIA other than oligoarticular, polyarticular type
Facility Information:
Facility Name
University of Pécs, Medical School, Department of Paediatrics
City
Pécs
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
33363071
Citation
Nagy A, Mosdosi B, Simon D, Dergez T, Berki T. Peripheral Blood Lymphocyte Analysis in Oligo- and Polyarticular Juvenile Idiopathic Arthritis Patients Receiving Methotrexate or Adalimumab Therapy: A Cross-Sectional Study. Front Pediatr. 2020 Dec 10;8:614354. doi: 10.3389/fped.2020.614354. eCollection 2020.
Results Reference
derived
Learn more about this trial
The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary
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