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

Rheumatic Disease Clinical Trial

Official title:

Yunnan University of Traditional Chinese Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191368
• Other study ID #: Yunnan University of CM
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2022
• Source: Yunnan University of Chinese Medicine
• Contact: Ting Zhao
• Phone: 18468146375
• Email: 420922691[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Disease
• Rheumatic Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Yunnan University of traditional Chinese Medicine	Kunming	Kunming

Sponsors (1)

Lead Sponsor	Collaborator
Yunnan University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sars-cov-2 neutralizing antibody	Inhibition rate of sars-cov-2 neutralizing antibody	2022.01.01