Metabolic Associated Fatty Liver Disease
Conditions
Keywords
SARS-CoV-2, vaccination, immune response
Brief summary
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
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.
Interventions
BIOLOGICALRecombinant protein vaccine and adenovirus vector vaccine
Administer recombinant protein vaccine and adenovirus vector vaccine
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Strengthened by the third dose of SARS-CoV-2 vaccination in MAFDL population. 2. Age ≥18 years old, gender unlimited. 3. Persons who agree to participate in this clinical trial and sign informed consent voluntarily.
Exclusion criteria
1. Persons who failed to complete SARS-CoV-2 vaccination. 2. Start vaccination but do not strictly follow the vaccination schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic monitoring of neutralizing antibody titers | 28 days | Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) | 28 days | Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) against different spike protein antigens of SARS-CoV-2 vaccination |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins | 28 days | Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins induced by SARS-CoV-2 vaccination |
Contacts
Primary ContactJie Li, M.D., Ph.D
Backup ContactJian Wang
Outcome results
None listed