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Completed

NCT Number: NCT02240888

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

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.

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Key information

Conditions

RA Cardiovascular Diseases Connective Tissue Diseases Disease Pathologic Processes Pathological Conditions, Signs and Symptoms SLE Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Sjögrens Skin Diseases Skin and Connective Tissue Diseases Syndrome Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University hospital, Dept of rheumatology

Lund, SE-22185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0,5 mg Prevenar i.m.

Biological

0,5 mg seasonal influenza vaccine i.m.

Biological

Primary outcomes

  1. antibody response following vaccination

    Time frame: 4-6 weeks after pneumococcal and influenza vaccination

    measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains

Secondary outcomes

  1. long-term immunity following pneumococcal vaccination

    Time frame: 3 years after pneumococcal vaccination

    measurement of antibody levels against different pneumococcal capsular serotypes

  2. long-term immunity after vaccination with pneumococcal conjugate vaccine

    Time frame: 5 years after vaccination

    measurement of antibody levels against different pneumococcal polysaccharide serotypes

Other outcomes

  1. The occurence of severe pneumococcal infections in immunized patients

    Time frame: within 5 years after pneumococcal vaccination

    Analysis of the occurence of severe pneumococcal infections in immunized patients compared to matched not-immunized controls

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: Vaccimil

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Sep 16, 2014
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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