Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response
NCT ID: NCT02240888
Last Updated: 2018-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2011-10-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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vaccinated patients
patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
0,5 mg Prevenar i.m.
0,5 mg seasonal influenza vaccine i.m.
vaccinated controls
healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
0,5 mg Prevenar i.m.
0,5 mg seasonal influenza vaccine i.m.
seasonal influenza vaccine
patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
0,5 mg Prevenar i.m.
0,5 mg seasonal influenza vaccine i.m.
non-vaccinated controls
healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
0,5 mg Prevenar i.m.
0,5 mg seasonal influenza vaccine i.m.
Interventions
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0,5 mg Prevenar i.m.
0,5 mg seasonal influenza vaccine i.m.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnancy,
* known intolerance of vaccine,
* ongoing infection
18 Years
ALL
Yes
Sponsors
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Region Skane
OTHER
Responsible Party
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meliha crnkic kapetanovic
MD, PhD, associate professor
Principal Investigators
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Meliha C Kapetanovic, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Skåne
Jehns Martineus, MD
Role: STUDY_DIRECTOR
Skåne Universitets sjukhus, dept of rheumatology
Locations
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Skåne University hospital, Dept of rheumatology
Lund, , Sweden
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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Vaccimil
Identifier Type: OTHER
Identifier Source: secondary_id
2011/341
Identifier Type: -
Identifier Source: org_study_id
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