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

NCT02240888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-10-03

No results posted yet for this 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.

Conditions

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

Interventions

BIOLOGICAL

0,5 mg Prevenar i.m.

BIOLOGICAL

0,5 mg seasonal influenza vaccine i.m.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Meliha C Kapetanovic, MD, PhD · Region Skåne

  • Jehns Martineus, MD · Skåne Universitets sjukhus, dept of rheumatology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-12-31
Completion
2018-05-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02240888 on ClinicalTrials.gov