Safety and Immunogenicity of COVID-19 Vaccine Booster in Patients With Liver Diseases (NMCIDCHESS2201)

Fudan University

Status: Unknown

Conditions: COVID-19; Vaccine Reaction; Liver Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT05204602

CLD-BOOST

Details and patient eligibility

About

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.