Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

Study Overview
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Brief Summary
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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.

Official Title
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Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.

Conditions
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Rheumatoid Arthritis, Systemic Lupus, Sjögren Syndrome, Systemic Vasculitis, Spondyloarthritis

Intervention / Treatment
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* Biological: 13-valent pneumococcal conjugate vaccine
* Biological: 23-valent pneumococcal polysaccharide vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCV13+PPV23 vaccinated patients<br>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<br>* Pneumococcal conjugate vaccination during antirheumatic treatment<br>* Other names: PCV13;Biological: 23-valent pneumococcal polysaccharide vaccine<br>* Pneumococcal polysaccharide vaccination during antirheumatic treatment<br>* Other names: PPV23;|
| Active Comparator: PCV13+PPV23 vaccinated controls<br>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<br>* Pneumococcal conjugate vaccination during antirheumatic treatment<br>* Other names: PCV13;Biological: 23-valent pneumococcal polysaccharide vaccine<br>* Pneumococcal polysaccharide vaccination during antirheumatic treatment<br>* Other names: PPV23;|
| Active Comparator: PPV23-booster to previous PCV-vaccinated patients<br>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<br>* Pneumococcal polysaccharide vaccination during antirheumatic treatment<br>* Other names: PPV23;|
| Active Comparator: PCV13 to previous PPV23-vaccinated patients<br>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<br>* Pneumococcal conjugate vaccination during antirheumatic treatment<br>* Other names: PCV13;|
| Active Comparator: PPV23-booster to previous PCV-vaccinated controls<br>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<br>* Pneumococcal polysaccharide vaccination during antirheumatic treatment<br>* Other names: PPV23;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-fold rise in pneumococcal serotype-specific antibody concentration | Pneumococcal serotype-specific antibody concentration (12-valent) | 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional antibody response | Opsonophagocytosis activity assay | 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 | 3 years after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal Conjugate Vaccine, Pneumococcal Disease, Immune Response, Inflammatory Rheumatic Disease, Pneumococcal Polysaccharide Vaccine, Immunosuppression