Clinical trial NCT05191368: Safety and Immunogenicity of Sars-cov-2 Vaccine in Patients With Rheumatic Diseases
Official title: Yunnan University of Traditional Chinese Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic Disease
Lead sponsor: Yunnan University of Chinese Medicine
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: ① Meet the diagnostic criteria of rheumatic diseases in western medicine;

② 18-70 years old, male or female;

③ The patient voluntarily participated in this clinical study, has been informed of relevant matters, and signed the informed consent form

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sars-cov-2 neutralizing antibody
timeFrame: 2022.01.01
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan University of traditional Chinese Medicine
state: Kunming
Study officials:
affiliation: Yunnan University of Chinese Medicine
name: Fanying Meng
role: STUDY_DIRECTOR
References: