Safety and Immunogenicity of Sars-cov-2 Vaccine in Patients With Rheumatic Diseases

NCT ID: NCT05191368

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-12

Study Completion Date

2022-06-01

Brief Summary

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The purpose of this study was to preliminarily evaluate the immunogenicity of sars-cov-2 vaccine in patients with rheumatic diseases. The clinical information collection and blood sample testing of 100 healthy people and 200 patients with rheumatic diseases will be completed in Yunnan Traditional Chinese medicine hospital.

Research methods and procedures: clinical information collection and blood sample detection were carried out in healthy people and patients with rheumatic diseases, including systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic sclerosis (SSC), idiopathic inflammatory myopathy (IIM), systemic vasculitis and spinal arthritis

Detailed Description

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Rheumatic diseases (RDS) are a large class of systemic diseases caused by genetic background, environment and physics, infection, metabolism, endocrine, immune response and other reasons, mainly involving joints and surrounding tissues. The diseases covered include systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), rheumatoid arthritis (RA) Sjogren's syndrome (SS), systemic sclerosis (SSC), idiopathic inflammatory myopathy (IIM), systemic vasculitis, spinal arthritis, etc. Patients with rheumatic diseases have an increased risk of infection due to autoimmune dysfunction and long-term use of hormones and immunosuppressants.

The incidence rate of coronary heart disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2) in 2019 has resulted in high incidence and mortality worldwide. Although the epidemic prevention measures such as keeping distance and quarantine isolation have effectively improved and limited the epidemic scope and the number of infected people, the groups with low immunity are still the susceptible groups of sars-cov-2.

Vaccination is very important to suppress the epidemic and reduce the overall mortality. It can protect people from sars-cov-2 infection and the deterioration of covid-192, and has good safety. However, there are not enough reports on the safety and immunogenicity of sars-cov-2 vaccine in patients with rheumatic diseases. Studies have reported that the immunogenicity of sars-cov-2 vaccine is reduced in immunocompromised patients, including the use of immunosuppressive drugs.

Conditions

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Rheumatic Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Normal group

Healthy people who received two doses of COVID-19 vaccine

No intervention

Intervention Type OTHER

No intervention

RA Patients injected with 2 doses of vaccine

RA Patients who received two doses of COVID-19 vaccine

No intervention

Intervention Type OTHER

No intervention

Unvaccinated RA patients

RA Patients who received zero doses of COVID-19 vaccine

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Meet the diagnostic criteria of rheumatic diseases in western medicine;

* 18-70 years old, male or female;

* The patient voluntarily participated in this clinical study, has been informed of relevant matters, and signed the informed consent form

Exclusion Criteria

It does not meet the diagnostic criteria of rheumatic diseases in western medicine
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yunnan University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ting Zhao

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fanying Meng

Role: STUDY_DIRECTOR

Yunnan University of Chinese Medicine

Locations

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Yunnan University of traditional Chinese Medicine

Kunming, Kunming, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Zhao

Role: CONTACT

18468146375

Fanying Meng

Role: CONTACT

18211951157

Facility Contacts

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Ting Zhao, Resident

Role: primary

18468146375

Other Identifiers

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Yunnan University of CM

Identifier Type: -

Identifier Source: org_study_id

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