Back to resultsCOVID-19 Vaccination in Rheumatic Disease Patients
Primary Purpose
Systemic Lupus Erythematosus, Sjogren's Syndrome, Inflammatory Myositis
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA COVD19 vaccine
Sponsored by
About this trial
This is an interventional health services research trial for Systemic Lupus Erythematosus
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
mRNA COVID19 vaccines
Arm Description
mRNA-based COVID19 vaccines
Outcomes
Primary Outcome Measures
Humoral responses towards mRNA COVID-19 vaccines
We aim to examine SARS-Cov2 specific antibody, and autoantibody generation
Secondary Outcome Measures
Cellular immune responses towards mRNA COVID-19 vaccines
measurement of immune cell distributions, type I interferon activity, and SARS-Cov2 specific T cell responses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04839315
Brief Title
COVID-19 Vaccination in Rheumatic Disease Patients
Official Title
Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with enrollment
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Sjogren's Syndrome, Inflammatory Myositis, Psoriatic Arthritis, Gout, Ankylosing Spondylitis, Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis), Osteoarthritis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mRNA COVID19 vaccines
Arm Type
Other
Arm Description
mRNA-based COVID19 vaccines
Intervention Type
Biological
Intervention Name(s)
mRNA COVD19 vaccine
Intervention Description
Subjects will receive two doses of mRNA based COVID19 vaccines.
Primary Outcome Measure Information:
Title
Humoral responses towards mRNA COVID-19 vaccines
Description
We aim to examine SARS-Cov2 specific antibody, and autoantibody generation
Time Frame
2 weeks to 6 months after second dose of vaccine
Secondary Outcome Measure Information:
Title
Cellular immune responses towards mRNA COVID-19 vaccines
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu Zeng, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
COVID-19 Vaccination in Rheumatic Disease Patients
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