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

Not yet recruiting

• Conditions: Metabolic Associated Fatty Liver Disease
• Interventions: Biological: Recombinant protein vaccine and adenovirus vector vaccine

• Registration Number: NCT05738707
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study First Submitted: 2023-01-28
• Status Verified: 2023-02
• Study Start: 2023-02
• Study First Submitted QC: 2023-02-12
• Last Update Submitted: 2023-02-12
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Primary Completion: 2026-01
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recombinant protein vaccine	Recombinant protein vaccine and adenovirus vector vaccine	-
Adenovirus vector vaccine	Recombinant protein vaccine and adenovirus vector vaccine	-

Primary Outcome Measures

Name	Time	Method
Dynamic monitoring of neutralizing antibody titers	180 days	Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination

Secondary Outcome Measures

Name	Time	Method
Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)	180 days	Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) against different spike protein antigens of SARS-CoV-2 vaccination