COVID-19 Vaccination in Rheumatic Disease Patients

Early Phase 1TerminatedNCT04839315

Mayo Clinic58 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

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

Interventions

mRNA COVD19 vaccineBIOLOGICAL

Subjects will receive two doses of mRNA based COVID19 vaccines.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Humoral responses towards mRNA COVID-19 vaccines

We aim to examine SARS-Cov2 specific antibody, and autoantibody generation

Time frame: 2 weeks to 6 months after second dose of vaccine

Secondary Outcomes

Cellular immune responses towards mRNA COVID-19 vaccines

measurement of immune cell distributions, type I interferon activity, and SARS-Cov2 specific T cell responses

Time frame: 2 weeks to 6 months after second dose of vaccine

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.