COVID-19 Vaccination in Rheumatic Disease Patients

May 31, 2022 updated by: Hu Zeng, Mayo Clinic

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: mRNA COVID19 vaccines
mRNA-based COVID19 vaccines
Biological: mRNA COVD19 vaccine
Subjects will receive two doses of mRNA based COVID19 vaccines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks to 6 months after second dose of vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks to 6 months after second dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Hu Zeng, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

February 9, 2022

Study Completion (Actual)

February 9, 2022

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-000501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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