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

Study Overview
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Brief Summary
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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

Official Title
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Safety and Immunogenicity of Third Dose SARS-CoV-2 Vaccine Booster in Patients With Liver Diseases Following Two Doses of Inactivated Vaccines (NMCID-CHESS 2201): a Multicenter Cohort Study

Conditions
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COVID-19, Vaccine Reaction, Liver Diseases

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of neutralizing antibody serological conversion after the booster vaccination | Neutralizing antibody serological conversion is defined as a change from seronegative at baseline to seropositive or a four-fold titre increase if the participant was seropositive at baseline. | Fourteen to 90 days after the booster vaccine | 
| Number and rate of all solicited and non-solicited adverse events | First 7 days after the booster dose, participants will be required to record and be interviewed for adverse events; from day 8 to day 28 after booster dose, safety data were collected by spontaneous report. | Up to 28 days after booster vaccine injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and rate of abnormal laboratory testing results after the booster vaccination | Abnormal laboratory testing results will be record and grade for severity. | Up to 28 days after after booster vaccine injection | 
| Concentration and titre of neutralizing antibody after booster vaccination | The results will be generated from competitive binding immuoenzymatic capture chemiluminescence immunoassays | Baseline and 14 days, 28 days, 90 days, and 180 days after the booster vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2 vaccine booster, liver diseases, safety, immunogenicity