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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Pneumococcal conjugate vaccination during antirheumatic treatment
Pneumococcal polysaccharide vaccination during antirheumatic treatment
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
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