COVID-19 Vaccination in Rheumatic Disease Patients

Study Overview
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Brief Summary
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The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.

Detailed Description
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Because patients treated with immunosuppressive agents have been excluded from initial clinical trials, and most patients with rheumatic diseases are taking immunosuppressants, the immune responses towards the mRNA COVID19 vaccines in these patients remains unknown. The goal is to study the immune response to COVID-19 vaccination in patients with rheumatic diseases. Blood samples collected before and longitudinally after mRNA-based COVID-19 vaccination (i.e., Pfizer and Moderna vaccines) will enable detailed immunological investigation of the interaction between COVID-19 vaccination and rheumatic diseases. These efforts will provide novel insights into the COVID-19 vaccine response in patients with rheumatic diseases, and eventually would inform clinical management to improve patient care.

Official Title
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Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases

Conditions
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Systemic Lupus Erythematosus, Sjogren's Syndrome, Inflammatory Myositis, Psoriatic Arthritis, Gout, Ankylosing Spondylitis, Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis), Osteoarthritis

Intervention / Treatment
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* Biological: mRNA COVD19 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rheumatologist confirmed diagnosis of one of the following diagnoses: Systemic lupus erythematosus; Sjogren syndrome; Inflammatory myositis; Psoriatic arthritis; Osteoarthritis; Gout; Ankylosing spondylitis; IBD-related arthritis. Exclusion Criteria: Active infection or untreated malignancy (other than skin cancer) at enrollment. Pregnancy

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: mRNA COVID19 vaccines<br>mRNA-based COVID19 vaccines | Biological: mRNA COVD19 vaccine<br>* Subjects will receive two doses of mRNA based COVID19 vaccines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral responses towards mRNA COVID-19 vaccines | We aim to examine SARS-Cov2 specific antibody, and autoantibody generation | 2 weeks to 6 months after second dose of vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular immune responses towards mRNA COVID-19 vaccines | measurement of immune cell distributions, type I interferon activity, and SARS-Cov2 specific T cell responses | 2 weeks to 6 months after second dose of vaccine |