Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response

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 immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. 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, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. 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.

Conditions
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RA, SLE, Vasculitis, Scleroderma, Sjögrens, Syndrome

Intervention / Treatment
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* Biological: 0,5 mg Prevenar i.m.
* Biological: 0,5 mg seasonal influenza vaccine i.m.


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, smoking habits and alcohol consumption. Exclusion Criteria: age <18 years; pregnancy, known intolerance of vaccine, ongoing 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vaccinated patients<br>patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m. | Biological: 0,5 mg Prevenar i.m.<br> <br> Biological: 0,5 mg seasonal influenza vaccine i.m.<br> <br> |
| Active Comparator: vaccinated controls<br>healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m. | Biological: 0,5 mg Prevenar i.m.<br> <br> Biological: 0,5 mg seasonal influenza vaccine i.m.<br> <br> |
| Active Comparator: seasonal influenza vaccine<br>patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m. | Biological: 0,5 mg Prevenar i.m.<br> <br> Biological: 0,5 mg seasonal influenza vaccine i.m.<br> <br> |
| Active Comparator: non-vaccinated controls<br>healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m. | Biological: 0,5 mg Prevenar i.m.<br> <br> Biological: 0,5 mg seasonal influenza vaccine i.m.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibody response following vaccination | measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains | 4-6 weeks after pneumococcal and influenza vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term immunity following pneumococcal vaccination | measurement of antibody levels against different pneumococcal capsular serotypes | 3 years after pneumococcal vaccination | 
| long-term immunity after vaccination with pneumococcal conjugate vaccine | measurement of antibody levels against different pneumococcal polysaccharide serotypes | 5 years after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunosuppressive, pneumococcal, vaccination, antibody, response, treatment, inflammatory, rheumatic, disease