Rheumatoid Arthritis, Systemic Lupus, Sjögren Syndrome, Systemic Vasculitis, Spondyloarthritis
Conditions
Keywords
Pneumococcal Conjugate Vaccine, Pneumococcal Disease, Immune Response, Inflammatory Rheumatic Disease, Pneumococcal Polysaccharide Vaccine, Immunosuppression
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 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.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
Pneumococcal polysaccharide vaccination during antirheumatic treatment
Sponsors
Region Skane
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
* known allergy/intolerance of pneumococcal vaccine * pregnancy * active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-fold rise in pneumococcal serotype-specific antibody concentration | 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination | Pneumococcal serotype-specific antibody concentration (12-valent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional antibody response | 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination | Opsonophagocytosis activity assay |
| Long-term serotype-specific immunity to pneumococcal disease | 3 years after vaccination | Pneumococcal serotype-specific antibody concentration |
Outcome results
None listed