Evaluating the inactivated COVID-19 vaccine's effectiveness and safety in patients with autoimmune diseases in China

Multicenter Clinical and Basic Research on the Prevention and Treatment of 2019-nCoV by Integrated Traditional Chinese and Western Medicine

This study is testing how well and safely the inactivated COVID-19 vaccine works for people with autoimmune diseases in China, especially those on immunosuppressive therapy, and if combining it with traditional Chinese medicine can improve results.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Zhejiang Chinese Medical University (other gov)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05831826 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and safety of the inactivated COVID-19 vaccine among patients with autoimmune diseases in China. It will involve a multi-center approach to observe the vaccine's preventive effects and safety, particularly in patients undergoing immunosuppressive therapy. The study also explores the combined use of traditional Chinese medicine with the vaccine to enhance treatment outcomes. By gathering high-quality evidence, the research seeks to provide a scientific basis for the clinical value of the vaccine in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with specific autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, and others as defined by established criteria.

Not a fit: Patients without autoimmune diseases or those who have not received immunosuppressive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve vaccination strategies and health outcomes for patients with autoimmune diseases during the COVID-19 pandemic.

How similar studies have performed: Other studies have indicated the importance of vaccination in immunocompromised populations, but this specific combination of traditional and western medicine approaches is relatively novel.

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.

Where this trial is running

Hangzhou, Zhejiang

• The Affiliated Hospital of Zhejiang Chinese Medicine University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Wumeng Jin — Zhejiang Chinese Medical University
• Study coordinator: Wumeng Jin

Conditions: COVID-19 Vaccines, Autoimmune Diseases