The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary
Early Phase 1
Completed
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- Biological: Influenza vaccine, Immune function
- Registration Number
- NCT03833271
- Lead Sponsor
- University of Pecs
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TNF-alpha inhibitor Influenza vaccine, Immune function - Methotrexate Influenza vaccine, Immune function - Healthy Influenza vaccine, Immune function -
- Primary Outcome Measures
Name Time Method Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab) 12-14 weeks Analysing T and B cells (%, /microL) by flow cytometry.
Immune response to influenza vaccine, the rate of seroconversion 12-14 weeks Measuring seroconversion after influenza vaccine (IU)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pécs, Medical School, Department of Paediatrics
🇭🇺Pécs, Hungary