A Phase 4 interventional study of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in Rheumatoid Arthritis, Systemic Lupus and Sjögren Syndrome, sponsored by Region Skane. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Region Skane · Phase 4, Interventional, and Prevention
The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. 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 and efficacy in preventing invasive pneumococcal disease. 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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 300 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
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.
Biological: 13-valent pneumococcal conjugate vaccine · Biological: 23-valent pneumococcal polysaccharide vaccine
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.
Biological: 13-valent pneumococcal conjugate vaccine · Biological: 23-valent pneumococcal polysaccharide vaccine
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.
Biological: 23-valent pneumococcal polysaccharide vaccine
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.
Biological: 13-valent pneumococcal conjugate vaccine
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.
Biological: 23-valent pneumococcal polysaccharide vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
Also known as: Prevenar 13, PCV13
Pneumococcal polysaccharide vaccination during antirheumatic treatment
Also known as: Pneumovax, PPV23
2-fold rise in pneumococcal serotype-specific antibody concentration
Pneumococcal serotype-specific antibody concentration (12-valent)
Time frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
Functional antibody response
Opsonophagocytosis activity assay
Time frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
Long-term serotype-specific immunity to pneumococcal disease
Pneumococcal serotype-specific antibody concentration
Time frame: 3 years after vaccination
No study locations are listed for this record.
Plan to share: Undecided — If requested we will consider sharing unidentified individual patient data
Ran from Jun 2016 to primary completion in Sep 2018, 26 months.
Of 79 non-industry phase 4 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 92. This study's 26 months is below that.
Counting every sponsor, half of 104 studies reached it within 42 months; a quarter within 25 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: 13-valent pneumococcal vaccine · 23-valent pneumococcal capsular polysaccharide vaccine