Clinical trial NCT05831826: Effectiveness and Safety of the Inactivated COVID-19 Vaccine in Thousands of Patients With Autoimmune Diseases in China
Official title: Multicenter Clinical and Basic Research on the Prevention and Treatment of 2019-nCoV by Integrated Traditional Chinese and Western Medicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Vaccines
Autoimmune Diseases
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
First posted: 2023-04-26
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ADs (≥18 years old) were recruited into the study according to the following inclusion criteria: rheumatoid arthritis (RA) / American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 classification criteria; ankylosing spondylitis (AS) / the 1984 modified New York criteria; systemic lupus erythematosus (SLE) / 2019 EULAR/ACR classification criteria; Sjögren's Syndrome (SS) / 2016 ACR/EULAR Classification Criteria; systemic vasculitis. Patients were instructed to continue taking all drugs during the vaccination period, except for biotherapy that was delayed after the vaccination by physician's suggestion. The HC were healthy volunteers who did not receive immunosuppressive therapy.

Brief summary: According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling disease activity, and can play a positive role in the whole process of epidemic prevention and treatment. Now the investigators plan to conduct multi-center clinical and basic research to observe the preventive effect and safety of the vaccine on COVID-19, as well as the preventive effect of the combination of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence and provide scientific basis for the clinical value of the drug.

Detailed description: Autoimmune diseases are disorders of the body's immune function, involving multiple organs and tissues of the whole body, and characterized by a variety of specific or non-specific autoantibodies and inflammatory factors overexpression. However, during the global COVID-19 pandemic, patients with autoimmune diseases, especially those receiving immunosuppressive therapy, face a high burden of novel coronavirus pneumonia (COVID-19) and are at higher risk for severe infection and disease progression. At present, patients with autoimmune diseases should give priority to the prevention and treatment strategy of COVID-19, among which the vaccination of novel coronavirus vaccine is the most important means to actively build herd immunity and control the epidemic of novel coronavirus pneumonia, and the combination of traditional Chinese and western medicine is an essential and effective way to prevent and treat COVID-19 infection. According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling disease activity, and can play a positive role in the whole process of epidemic prevention and treatment. Now the investigators plan to conduct multi-center clinical and basic research to observe the preventive effect and safety of the vaccine on COVID-19, as well as the preventive effect of the combination of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence and provide scientific basis for the clinical value of the drug.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* The ADs group were diagnosed with autoimmune diseases according to the following inclusion criteria: rheumatoid arthritis (RA) / American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 classification criteria; ankylosing spondylitis (AS) / the 1984 modified New York criteria; systemic lupus erythematosus (SLE) / 2019 EULAR/ACR classification criteria; Sjögren's Syndrome (SS) / 2016 ACR/EULAR Classification Criteria; systemic vasculitis / Chapel Hill Consensus Conference definitions; idiopathic inflammatory myositis (IIM) / 2017 EULAR/ACR classification criteria; psoriatic arthritis (PsA) / 2006 Classification Criteria for PsA; systemic sclerosis (SSc) / 2013 ACR/EULAR collaborative initiative; polymyalgia rheumatica (PMR) / 2012 provisional classification criteria.
* The HC group were volunteers who did not have history of autoimmune diseases and did not receive immunosuppressive therapy.

Exclusion Criteria:

* history of COVID-19 infection
* history of vaccination allergy
* history of mental disabilities
* pregnancy
* unwillingness to sign informed consent.

Primary outcomes:
measure: Incidence of local and systemic adverse events
timeFrame: 3 years
measure: Concentration of anti-SARS-CoV-2 spike protein
timeFrame: 3 years
measure: Infection rate of COVID-19
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Affiliated Hospital of Zhejiang Chinese Medicine University
state: Zhejiang
Study officials:
affiliation: Zhejiang Chinese Medical University
name: Wumeng Jin
role: PRINCIPAL_INVESTIGATOR
References: