Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease
NCT ID: NCT03762824
Last Updated: 2023-03-29
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
PHASE4
300 participants
INTERVENTIONAL
2016-06-14
2020-12-21
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
PREVENTION
NONE
Study Groups
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PCV13+PPV23 vaccinated patients
Patients with different inflammatory rheumatic diseases are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
PCV13+PPV23 vaccinated controls
Healthy controls are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
PPV23-booster to previous PCV-vaccinated patients
Patients with different inflammatory rheumatic disease previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.
23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
PCV13 to previous PPV23-vaccinated patients
Patients with different inflammatory rheumatic disease previously immunized with one dose PPV23 within another study (see VACCIMIL), are immunized with one dose PCV13 0.5 ml i.m.
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
PPV23-booster to previous PCV-vaccinated controls
Healthy controls previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.
23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
Interventions
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13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnancy
* active infection
18 Years
ALL
Yes
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Jehns Martineus, MD
Role: STUDY_DIRECTOR
Skåne Universitets sjukhus, dept of rheumatology
References
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Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002 Sep;46(9):2287-93. doi: 10.1002/art.10524.
Kapetanovic MC, Saxne T, Sjoholm A, Truedsson L, Jonsson G, Geborek P. Influence of methotrexate, TNF blockers and prednisolone on antibody responses to pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis. Rheumatology (Oxford). 2006 Jan;45(1):106-11. doi: 10.1093/rheumatology/kei193. Epub 2005 Nov 15.
Kapetanovic MC, Roseman C, Jonsson G, Truedsson L, Saxne T, Geborek P. Antibody response is reduced following vaccination with 7-valent conjugate pneumococcal vaccine in adult methotrexate-treated patients with established arthritis, but not those treated with tumor necrosis factor inhibitors. Arthritis Rheum. 2011 Dec;63(12):3723-32. doi: 10.1002/art.30580.
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.
Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012 Oct 12;61(40):816-9.
Nived P, Jonsson G, Settergren B, Einarsson J, Olofsson T, Jorgensen CS, Skattum L, Kapetanovic MC. Prime-boost vaccination strategy enhances immunogenicity compared to single pneumococcal conjugate vaccination in patients receiving conventional DMARDs, to some extent in abatacept but not in rituximab-treated patients. Arthritis Res Ther. 2020 Feb 22;22(1):36. doi: 10.1186/s13075-020-2124-3.
Other Identifiers
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IPS-BOOSTER
Identifier Type: -
Identifier Source: org_study_id
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