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

• 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

Study Timeline

• Study Start: 2018-10-28
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-17

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

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)

Trial Locations

Locations (1)

University of Pécs, Medical School, Department of Paediatrics; 🇭🇺 Pécs, Hungary