NCT02240888

Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.

Conditions

• RA
• SLE
• Vasculitis
• Scleroderma
• Sjögrens
• Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	0,5 mg Prevenar i.m.
BIOLOGICAL	0,5 mg seasonal influenza vaccine i.m.

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-12-31
• Completion: 2018-05-31
• First posted: 2014-09-16
• Last updated: 2018-10-03

Locations

1 site across 1 country: Sweden