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NCT04839315 Clinical Trial

COVID-19 Vaccination in Rheumatic Disease Patients

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04839315
Other study ID # 21-000501
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
Start date February 15, 2021
Est. completion date February 9, 2022

Study information
Verified date May 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 58
Est. completion date February 9, 2022
Est. primary completion date February 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• mRNA COVD19 vaccine
Subjects will receive two doses of mRNA based COVID19 vaccines.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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