Safety and Immunogenicity of COVID-19 Vaccine Booster in Patients With Liver Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-10

Study Completion Date

2022-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Previous studies should that patients with chronic liver diseases, cirrhosis, hepatocellular carcinoma and post-liver-trasplant status had lower immunological response to SARS-CoV-2 vaccines than healthy population. Along with the waning of antibody and emerging SARS-CoV-2 variants, a third dose SARS-CoV-2 booster vaccination is now considered as an effective strategy. Previous studies showed good safety and immunogenicity of the SARS-CoV-2 booster vaccination in healthy population. However, the relevant information in patients with liver diseases need further research. This study (NMCID-CHESS 2201) aimed to investigate the safety and immunogenicity of the SARS-CoV-2 booster vaccination in population with chronic liver diseases

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

COVID-19 Vaccines in Patients With Chronic Liver Disease

NCT05017805

Liver Disease Chronic

UNKNOWN NA

Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases

NCT05007665

Liver Diseases Covid19 Adverse Reaction to Vaccine

UNKNOWN

Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C：An Open-label Control Study in China

NCT02898922

Hepatitis B Vaccines

COMPLETED PHASE4

"Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu

NCT03097952

Hepatitis B， Chronic

RECRUITING

Antibody Response to COVID-19 Vaccines in Liver Disease Patients

NCT04775069

Chronic Liver Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Vaccine Reaction Liver Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Previously vaccinated with two doses of SARS-CoV-2 vaccines and planning to get booster vaccination.
* Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver diseases, cirrhosis, liver cancer, liver transplant subjects, etc.
* Understanding and willing to comply with the study procedures and provides written informed consent.

Exclusion Criteria

* Pregnancy or lactation.
* Active or known history of SARS-CoV-2 infection.
* Diseases causing immunosuppressive or immunodeficient status or autoimmune diseases.
* A history of discontinuing anti-HBV agents in recent three months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wen-hong Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.