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

Study Overview
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Brief Summary
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On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with chronic liver diseases, and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.

Detailed Description
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Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as autoimmune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 / influenza vaccine can effectively prevent COVID-19 / influenza virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 / influenza vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, liver function, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and patients with chronic liver disease before and after vaccination ( 1, 3, 6, 12 months after vaccination). The adverse reactions related to the vaccine were recorded.

Official Title
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Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver （CQMU）

Conditions
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Liver Diseases, Covid19, Adverse Reaction to Vaccine

Intervention / Treatment
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* Biological: SARS-COV-2 VACCINE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy group were as follows: no history of hepatitis, no history of liver cirrhosis, no history of liver cancer and receiving the whole-course COVID-19 vaccination. Patients with chronic liver disease diagnosed clinically or pathologically and receiving the whole-course COVID-19 vaccination. Exclusion Criteria: Patients previously diagnosed or with a history of contact with confirmed cases Patients with contraindications for vaccination.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Liver Diseases Patients/Healthy People<br>Chronic hepatitis (B OR C) , autoimmune hepatitis, liver cirrhosis, primary hepatocellular carcinoma | Biological: SARS-COV-2 VACCINE<br>* the antibody titer and adverse reactions were observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events after injection. | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 4 weeks after vaccination | 
| Number of participants with adverse events after injection. | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 12 weeks after vaccination | 
| Number of participants with adverse events after injection. | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 24 weeks after vaccination | 
| Number of participants with adverse events after injection. | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 48 weeks after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 4 weeks | 4 weeks after vaccination | 
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 12 weeks | 12 weeks after vaccination | 
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 24 weeks | 24 weeks after vaccination | 
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 48 weeks after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with chronic liver disease. | 48 weeks after vaccination |