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COVID-19 Vaccination in Rheumatic Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04839315
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Information provided by (Responsible Party):
Hu Zeng, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Sjogren's Syndrome Inflammatory Myositis Psoriatic Arthritis Gout Ankylosing Spondylitis Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis) Osteoarthritis Biological: mRNA COVD19 vaccine Early Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
mRNA COVID19 vaccines
mRNA-based COVID19 vaccines
Biological: mRNA COVD19 vaccine
Subjects will receive two doses of mRNA based COVID19 vaccines.

Primary Outcome Measures :
  1. Humoral responses towards mRNA COVID-19 vaccines [ Time Frame: 2 weeks to 6 months after second dose of vaccine ]
    We aim to examine SARS-Cov2 specific antibody, and autoantibody generation

Secondary Outcome Measures :
  1. Cellular immune responses towards mRNA COVID-19 vaccines [ Time Frame: 2 weeks to 6 months after second dose of vaccine ]
    measurement of immune cell distributions, type I interferon activity, and SARS-Cov2 specific T cell responses

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04839315

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jane M Jaquith    507-284-4502   
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Hu Zeng, PhD Mayo Clinic
Additional Information:
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Responsible Party: Hu Zeng, Principal Investigator, Mayo Clinic Identifier: NCT04839315    
Other Study ID Numbers: 21-000501
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis, Psoriatic
Spondylitis, Ankylosing
Rheumatic Diseases
Sjogren's Syndrome
Inflammatory Bowel Diseases
Lupus Erythematosus, Systemic
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Arthritis, Rheumatoid