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

October 1, 2018 updated by: meliha crnkic kapetanovic, Region Skane
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, SE-22185
        • Skåne University hospital, Dept of rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vaccinated patients
patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
Biological: 0,5 mg Prevenar i.m.
Biological: 0,5 mg seasonal influenza vaccine i.m.
Active Comparator: vaccinated controls
healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
Biological: 0,5 mg Prevenar i.m.
Biological: 0,5 mg seasonal influenza vaccine i.m.
Active Comparator: seasonal influenza vaccine
patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
Biological: 0,5 mg Prevenar i.m.
Biological: 0,5 mg seasonal influenza vaccine i.m.
Active Comparator: non-vaccinated controls
healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
Biological: 0,5 mg Prevenar i.m.
Biological: 0,5 mg seasonal influenza vaccine i.m.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-6 weeks after pneumococcal and influenza vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term immunity following pneumococcal vaccination
Time Frame: 3 years after pneumococcal vaccination
measurement of antibody levels against different pneumococcal capsular serotypes
3 years after pneumococcal vaccination
long-term immunity after vaccination with pneumococcal conjugate vaccine
Time Frame: 5 years after vaccination
measurement of antibody levels against different pneumococcal polysaccharide serotypes
5 years after vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 5 years after pneumococcal vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Director: Jehns Martineus, MD, Skåne Universitets sjukhus, dept of rheumatology
  • Principal Investigator: Meliha C Kapetanovic, MD, PhD, Region Skane

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/341
  • Vaccimil (Other Identifier: Vaccimil)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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