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

Yunnan University of Traditional Chinese Medicine

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05191368
Enrollment
500
Registered
2022-01-13
Start date
2022-01-12
Completion date
2022-06-01
Last updated
2022-01-28

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

Conditions

Rheumatic Disease

Brief summary

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

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Yunnan University of Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sars-cov-2 neutralizing antibody2022.01.01Inhibition rate of sars-cov-2 neutralizing antibody

Countries

China

Contacts

Primary ContactTing Zhao
420922691@qq.com18468146375
Backup ContactFanying Meng
1026792964@qq.com18211951157

Outcome results

None listed

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