Clinical Study of SARS-CoV-2 Vaccine in Metabolism-related Fatty Liver Disease

Study Overview
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Brief Summary
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The coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 causes high morbidity and mortality worldwide. SARS-CoV-2 vaccination is currently the most effective means of reducing morbidity, severe illness and mortality risk. This study aimed to establish a metabolic associated fatty liver disease (MAFLD) cohort of sequential booster SARS-CoV-2 vaccination, and to identify the dynamic changes of immune response induced by sequential booster SARS-CoV-2 vaccination in MAFLD population. To investigate the effects of blood routine, liver function biochemistry and coagulation function at 28 days, 57 days and 180 days after inoculation of SARS-CoV-2 vaccination.

Detailed Description
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The coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 causes high morbidity and mortality worldwide. SARS-CoV-2 vaccination is currently the most effective means of reducing morbidity, severe illness and mortality risk. Metabolic associated fatty liver disease (MAFLD) has a prevalence rate of 29.63% in China, which is the most common chronic liver disease in China. This study aimed to establish a metabolic associated fatty liver disease (MAFLD) cohort of sequential booster SARS-CoV-2 vaccination, and to identify the dynamic changes of immune response induced by sequential booster SARS-CoV-2 vaccination in MAFLD population. To investigate the effects of blood routine, liver function biochemistry and coagulation function at 28 days, 57 days and 180 days after inoculation of SARS-CoV-2 vaccination. Safety and adverse events were assessed using an electronic questionnaire at days 1, 3, 5, and 7 after enrollment. Serum and peripheral blood PBMC were collected at baseline and 28, 57, and 180 days after vaccination. Blood routine, liver function biochemistry, coagulation function, antibodies, peripheral blood cell subtypes and serum, and PBMC proteomics were tested to evaluate the antibody and immune response induced by SARS-CoV-2 vaccination.

Official Title
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Clinical Study of SARS-CoV-2 Vaccine Sequentially Enhancing Immune Response in Metabolism-related Fatty Liver Disease Based on Deep Machine Learning

Conditions
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Metabolic Associated Fatty Liver Disease

Intervention / Treatment
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* Biological: Recombinant protein vaccine and adenovirus vector vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Strengthened by the third dose of SARS-CoV-2 vaccination in MAFDL population. Age ≥18 years old, gender unlimited. Persons who agree to participate in this clinical trial and sign informed consent voluntarily. Exclusion Criteria: Persons who failed to complete SARS-CoV-2 vaccination. Start vaccination but do not strictly follow the vaccination schedule.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recombinant protein vaccine<br> | Biological: Recombinant protein vaccine and adenovirus vector vaccine<br>* Administer recombinant protein vaccine and adenovirus vector vaccine<br>|
| Adenovirus vector vaccine<br> | Biological: Recombinant protein vaccine and adenovirus vector vaccine<br>* Administer recombinant protein vaccine and adenovirus vector vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic monitoring of neutralizing antibody titers | Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination | 28 days | 
| Dynamic monitoring of neutralizing antibody titers | Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination | 57 days | 
| Dynamic monitoring of neutralizing antibody titers | Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) | Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) against different spike protein antigens of SARS-CoV-2 vaccination | 28 days | 
| Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) | Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) against different spike protein antigens of SARS-CoV-2 vaccination | 57 days | 
| Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) | Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) against different spike protein antigens of SARS-CoV-2 vaccination | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, vaccination, immune response