Safety and Immunogenicity of Sars-cov-2 Vaccine in Patients With Rheumatic Diseases
NCT ID: NCT05191368
Last Updated: 2022-01-28
Study Results
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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UNKNOWN
500 participants
OBSERVATIONAL
2022-01-12
2022-06-01
Brief Summary
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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
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Detailed Description
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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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Study Design
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OTHER
OTHER
Study Groups
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Normal group
Healthy people who received two doses of COVID-19 vaccine
No intervention
No intervention
RA Patients injected with 2 doses of vaccine
RA Patients who received two doses of COVID-19 vaccine
No intervention
No intervention
Unvaccinated RA patients
RA Patients who received zero doses of COVID-19 vaccine
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Yunnan University of Chinese Medicine
OTHER
Responsible Party
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Ting Zhao
doctor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Yunnan University of CM
Identifier Type: -
Identifier Source: org_study_id
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