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

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

Not yet recruiting
Metabolic Associated Fatty Liver Disease

Biological: Recombinant protein vaccine and adenovirus vector vaccine

Administer recombinant protein vaccine and adenovirus vector vaccine

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Locations

Not Provided

Contacts

Jie Li, M.D., Ph.D
86-15863787910
lijier@sina.com

Jian Wang
86-13063335263
13063335263@163.com

Not Provided

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT Number
Keywords
SARS-CoV-2
Vaccination
immune response
MeSH Terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Vaccines