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

Not Applicable

Completed

• Conditions: Syndrome; RA; SLE; Vasculitis; Scleroderma; Sjögrens
• Interventions: Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m.

• Registration Number: NCT02240888
• Lead Sponsor: Region Skane

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Primary Completion: 2017-12-31
• Study Completion: 2018-05-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• age <18 years;
• pregnancy,
• known intolerance of vaccine,
• ongoing infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
seasonal influenza vaccine	0,5 mg seasonal influenza vaccine i.m.	patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
vaccinated controls	0,5 mg Prevenar i.m.	healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
vaccinated controls	0,5 mg seasonal influenza vaccine i.m.	healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
vaccinated patients	0,5 mg Prevenar i.m.	patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
seasonal influenza vaccine	0,5 mg Prevenar i.m.	patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
non-vaccinated controls	0,5 mg Prevenar i.m.	healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
vaccinated patients	0,5 mg seasonal influenza vaccine i.m.	patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
non-vaccinated controls	0,5 mg seasonal influenza vaccine i.m.	healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.

Primary Outcome Measures

Name	Time	Method
antibody response following vaccination	4-6 weeks after pneumococcal and influenza vaccination	measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains

Secondary Outcome Measures

Name	Time	Method
long-term immunity following pneumococcal vaccination	3 years after pneumococcal vaccination	measurement of antibody levels against different pneumococcal capsular serotypes
long-term immunity after vaccination with pneumococcal conjugate vaccine	5 years after vaccination	measurement of antibody levels against different pneumococcal polysaccharide serotypes

Trial Locations

Locations (1)

Skåne University hospital, Dept of rheumatology; 🇸🇪 Lund, Sweden