Back to resultsVaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response (Vaccimil)
Primary Purpose
RA, SLE, Vasculitis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
0,5 mg Prevenar i.m.
0,5 mg seasonal influenza vaccine i.m.
Sponsored by
About this trial
This is an interventional treatment trial for RA focused on measuring pneumococcal, vaccination, antibody, response, immunosuppressive, treatment, inflammatory, rheumatic, disease
Eligibility 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
Sites / Locations
- Skåne University hospital, Dept of rheumatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
vaccinated patients
vaccinated controls
seasonal influenza vaccine
non-vaccinated controls
Arm Description
patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
Outcomes
Primary Outcome Measures
antibody response following vaccination
measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains
Secondary Outcome Measures
long-term immunity following pneumococcal vaccination
measurement of antibody levels against different pneumococcal capsular serotypes
long-term immunity after vaccination with pneumococcal conjugate vaccine
measurement of antibody levels against different pneumococcal polysaccharide serotypes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02240888
Brief Title
Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response
Acronym
Vaccimil
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RA, SLE, Vasculitis, Scleroderma, Sjögrens, Syndrome
Keywords
pneumococcal, vaccination, antibody, response, immunosuppressive, treatment, inflammatory, rheumatic, disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vaccinated patients
Arm Type
Active Comparator
Arm Description
patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
Arm Title
vaccinated controls
Arm Type
Active Comparator
Arm Description
healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
Arm Title
seasonal influenza vaccine
Arm Type
Active Comparator
Arm Description
patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
Arm Title
non-vaccinated controls
Arm Type
Active Comparator
Arm Description
healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
Intervention Type
Biological
Intervention Name(s)
0,5 mg Prevenar i.m.
Intervention Type
Biological
Intervention Name(s)
0,5 mg seasonal influenza vaccine i.m.
Primary Outcome Measure Information:
Title
antibody response following vaccination
Description
measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains
Time Frame
4-6 weeks after pneumococcal and influenza vaccination
Secondary Outcome Measure Information:
Title
long-term immunity following pneumococcal vaccination
Description
measurement of antibody levels against different pneumococcal capsular serotypes
Time Frame
3 years after pneumococcal vaccination
Title
long-term immunity after vaccination with pneumococcal conjugate vaccine
Description
measurement of antibody levels against different pneumococcal polysaccharide serotypes
Time Frame
5 years after vaccination
Other Pre-specified Outcome Measures:
Title
The occurence of severe pneumococcal infections in immunized patients
Description
Analysis of the occurence of severe pneumococcal infections in immunized patients compared to matched not-immunized controls
Time Frame
within 5 years after pneumococcal vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meliha C Kapetanovic, MD, PhD
Organizational Affiliation
Region Skåne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jehns Martineus, MD
Organizational Affiliation
Skåne Universitets sjukhus, dept of rheumatology
Official's Role
Study Director
Facility Information:
Facility Name
Skåne University hospital, Dept of rheumatology
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
30886963
Citation
Nived P, Saxne T, Geborek P, Mandl T, Skattum L, Kapetanovic MC. Antibody response to 13-valent pneumococcal conjugate vaccine is not impaired in patients with rheumatoid arthritis or primary Sjogren's syndrome without disease modifying treatment. BMC Rheumatol. 2018 Apr 5;2:12. doi: 10.1186/s41927-018-0019-6. eCollection 2018.
Results Reference
derived
PubMed Identifier
29325173
Citation
Hesselstrand R, Nagel J, Saxne T, Geborek P, Skattum L, Kapetanovic MC. Immunogenicity and safety of pneumococcal vaccination in patients with systemic sclerosis. Rheumatology (Oxford). 2018 Apr 1;57(4):625-630. doi: 10.1093/rheumatology/kex471. Erratum In: Rheumatology (Oxford). 2018 Apr 1;57(4):769.
Results Reference
derived
PubMed Identifier
28552512
Citation
Nived P, Nagel J, Saxne T, Geborek P, Jonsson G, Skattum L, Kapetanovic MC. Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy. Vaccine. 2017 Jun 22;35(29):3639-3646. doi: 10.1016/j.vaccine.2017.05.044. Epub 2017 May 25.
Results Reference
derived
PubMed Identifier
28081972
Citation
Kapetanovic MC, Nagel J, Nordstrom I, Saxne T, Geborek P, Rudin A. Methotrexate reduces vaccine-specific immunoglobulin levels but not numbers of circulating antibody-producing B cells in rheumatoid arthritis after vaccination with a conjugate pneumococcal vaccine. Vaccine. 2017 Feb 7;35(6):903-908. doi: 10.1016/j.vaccine.2016.12.068. Epub 2017 Jan 9.
Results Reference
derived
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Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response
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