Effectiveness and Safety of the Inactivated COVID-19 Vaccine in Thousands of Patients With Autoimmune Diseases in China

Launched by ZHEJIANG CHINESE MEDICAL UNIVERSITY · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of an inactivated COVID-19 vaccine for patients with autoimmune diseases. The goal is to see how well the vaccine works in preventing COVID-19 and to understand its safety when combined with traditional Chinese medicine. Researchers believe that this approach can help improve symptoms of COVID-19 in patients with autoimmune conditions, shorten the time they are sick, and help control their disease activity.

To participate in the trial, individuals must be at least 18 years old and have a diagnosed autoimmune disease, such as rheumatoid arthritis or lupus. There are also opportunities for healthy volunteers who do not have autoimmune diseases. Participants will receive the vaccine and be monitored for any side effects or improvements in their health. It's important to note that people with a history of COVID-19 infection, allergies to vaccines, or certain other health issues will not be eligible. This study is currently recruiting participants, and the findings will help provide valuable information about the vaccine's role in protecting those with autoimmune diseases.

Gender

ALL

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.