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

Metabolic Associated Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05738707
• Other study ID #: 2023-128
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: February 2026

Study information

• Verified date: February 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Jie Li, M.D., Ph.D
• Phone: 86-15863787910
• Email: lijier[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Associated Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Biological:
• Recombinant protein vaccine and adenovirus vector vaccine
Administer recombinant protein vaccine and adenovirus vector vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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	57 days
Other	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
Primary	Dynamic monitoring of neutralizing antibody titers	Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination	28 days
Primary	Dynamic monitoring of neutralizing antibody titers	Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination	57 days
Primary	Dynamic monitoring of neutralizing antibody titers	Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination	180 days
Secondary	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
Secondary	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	57 days
Secondary	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