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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant protein vaccine |
| ||
| Adenovirus vector vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant protein vaccine and adenovirus vector vaccine | Biological | Administer recombinant protein vaccine and adenovirus vector vaccine |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins | Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins induced by SARS-CoV-2 vaccination | 28 days |
| Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins |
Inclusion Criteria:
Exclusion Criteria:
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A total of 100 patients with MAFLD who had completed full inactivated vaccine for more than 6 months were given different sequential booster immunization regimens, including 50 patients receiving recombinant protein vaccine and 50 patients receiving adenovirus vector vaccine
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Li, M.D., Ph.D | Contact | 86-15863787910 | lijier@sina.com | |
| Jian Wang | Contact | 86-13063335263 | 13063335263@163.com |
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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 |
Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins induced by SARS-CoV-2 vaccination |
| 57 days |
| Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins | Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins induced by SARS-CoV-2 vaccination | 180 days |