Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Mayo Clinic
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Humoral responses towards mRNA COVID-19 vaccines
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Hu Zeng
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Rheumatologist confirmed diagnosis of one of the following diagnoses:
- •Systemic lupus erythematosus;
- •Sjogren syndrome;
- •Inflammatory myositis;
- •Psoriatic arthritis;
- •Osteoarthritis;
- •Ankylosing spondylitis;
- •IBD-related arthritis.
Exclusion Criteria
- •Active infection or untreated malignancy (other than skin cancer) at enrollment.
- •Pregnancy
Outcomes
Primary Outcomes
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 Outcomes
- Cellular immune responses towards mRNA COVID-19 vaccines(2 weeks to 6 months after second dose of vaccine)