We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02240888
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
meliha crnkic kapetanovic, Region Skane

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
RA SLE Vasculitis Scleroderma Sjögrens Syndrome Biological: 0,5 mg Prevenar i.m. Biological: 0,5 mg seasonal influenza vaccine i.m. Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot Vaccines

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240888


Locations
Layout table for location information
Sweden
Skåne University hospital, Dept of rheumatology
Lund, Sweden, SE-22185
Sponsors and Collaborators
Region Skane
Investigators
Layout table for investigator information
Principal Investigator: Meliha C Kapetanovic, MD, PhD Region Skåne
Study Director: Jehns Martineus, MD Skåne Universitets sjukhus, dept of rheumatology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: meliha crnkic kapetanovic, MD, PhD, associate professor, Region Skane
ClinicalTrials.gov Identifier: NCT02240888    
Other Study ID Numbers: 2011/341
Vaccimil ( Other Identifier: Vaccimil )
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Keywords provided by meliha crnkic kapetanovic, Region Skane:
pneumococcal
vaccination
antibody
response
immunosuppressive
 treatment
inflammatory
rheumatic
disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Vasculitis
Vascular Diseases
Cardiovascular Diseases
 Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs