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COVID-19 Vaccination in Rheumatic Disease Patients

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ClinicalTrials.gov Identifier: NCT04839315
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
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



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

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 ClinicalTrials.gov identifier (NCT number): NCT04839315


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jane M Jaquith    507-284-4502    jaquith.jane@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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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
ClinicalTrials.gov 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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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Rheumatic Diseases
Sjogren's Syndrome
Myositis
Inflammatory Bowel Diseases
Lupus Erythematosus, Systemic
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis
Arthritis, Rheumatoid