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

Last updated: October 1, 2018
Sponsor: Region Skane
Overall Status: Completed

Phase

N/A

Condition

Scleroderma

Lupus

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT02240888
2011/341
Vaccimil
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs orbiological remedies are offered to participate in the study. The protocol permitsstratification for prednisolone usage, smoking habits and alcohol consumption.

Exclusion

Exclusion Criteria:

  • age <18 years;

  • pregnancy,

  • known intolerance of vaccine,

  • ongoing infection

Study Design

Total Participants: 300
Study Start date:
October 01, 2011
Estimated Completion Date:
May 31, 2018

Connect with a study center

  • Skåne University hospital, Dept of rheumatology

    Lund, SE-22185
    Sweden

    Site Not Available

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