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

Nanjing University

Status: Not yet enrolling

Conditions: Metabolic Associated Fatty Liver Disease

Treatments: Biological: Recombinant protein vaccine and adenovirus vector vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05738707

2023-128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Recombinant protein vaccine

Treatment:

Biological: Recombinant protein vaccine and adenovirus vector vaccine

Adenovirus vector vaccine

Treatment:

Biological: Recombinant protein vaccine and adenovirus vector vaccine