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

NCT05831826 | Unknown

• 1 other identifier: ZhejiangCMU 2020-KL-0601-1
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Vaccines; Autoimmune Diseases

Outcome Measures

Primary Outcomes (3)

• Incidence of local and systemic adverse events

  One of the primary end point was the safety of the inactivated COVID-19 vaccine in adult patients with ADs compared with controls.

  3 years

• Concentration of anti-SARS-CoV-2 spike protein

  One of the primary end point was the immunogenicity of the inactivated COVID-19 vaccine in adult patients with ADs compared with controls.

  3 years

• Infection rate of COVID-19

  One of the primary end point was the efficacy of the inactivated COVID-19 vaccine in adult patients with ADs.

  3 years

Study Arms (3)

healthy controls

Healthy controls are ≥18 years old, no previous history of SARS-CoV-2 infection, and no previous history of autoimmune diseases. All the HC group were injected with 2 or 3 doses of inactivated SARS-CoV-2 vaccines.

Biological: the inactivated COVID-19 vaccines

the vaccinated patients with ADs

The vaccinated patients with ADs are ≥18 years old, no previous history of SARS-CoV-2 infection, and diagnosed with autoimmune diseases. All the group were injected with the inactivated SARS-CoV-2 vaccines.

Biological: the inactivated COVID-19 vaccines

the unvaccinated patients with ADs

The vaccinated patients with ADs are ≥18 years old, no previous history of SARS-CoV-2 infection, and diagnosed with autoimmune diseases. All the group were not injected with the inactivated SARS-CoV-2 vaccines.

Interventions

the inactivated COVID-19 vaccines BIOLOGICAL

receive the doses of inactivated COVID-19 vaccines

healthy controls; the vaccinated patients with ADs

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥18 years old
• The HC group were volunteers who did not have history of autoimmune diseases and did not receive immunosuppressive therapy.

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead

Study Sites (1)

The Affiliated Hospital of Zhejiang Chinese Medicine University

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples and urine samples

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Wumeng Jin

  Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wumeng Jin

CONTACT

+8615824198956; jwm8956@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: April 26, 2023
• Study Start: June 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

CN (1)