COVID-19 Vaccination in Rheumatic Disease Patients

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

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04839315

Enrollment

Registered

2021-04-09

Start date

2021-02-15

Completion date

2022-02-09

Last updated

2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis), Gout, Inflammatory Myositis, Osteoarthritis, Psoriatic Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus

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.

Interventions

BIOLOGICALmRNA COVD19 vaccine

Subjects will receive two doses of mRNA based COVID19 vaccines.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Humoral responses towards mRNA COVID-19 vaccines	2 weeks to 6 months after second dose of vaccine	We aim to examine SARS-Cov2 specific antibody, and autoantibody generation

Secondary

Measure	Time frame	Description
Cellular immune responses towards mRNA COVID-19 vaccines	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026