Clinical trial NCT05738707: Clinical Study of SARS-CoV-2 Vaccine in Metabolism-related Fatty Liver Disease
Official title: Clinical Study of SARS-CoV-2 Vaccine Sequentially Enhancing Immune Response in Metabolism-related Fatty Liver Disease Based on Deep Machine Learning
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metabolic Associated Fatty Liver Disease
Keywords: SARS-CoV-2
vaccination
immune response
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 100 patients with MAFLD who had completed full inactivated vaccine for more than 6 months were given different sequential booster immunization regimens, including 50 patients receiving recombinant protein vaccine and 50 patients receiving adenovirus vector vaccine

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.

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.

Primary outcomes:
measure: Dynamic monitoring of neutralizing antibody titers
timeFrame: 28 days
measure: Dynamic monitoring of neutralizing antibody titers
timeFrame: 57 days
measure: Dynamic monitoring of neutralizing antibody titers
timeFrame: 180 days
Secondary outcomes:
measure: Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)
timeFrame: 28 days
measure: Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)
timeFrame: 57 days
measure: Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)
timeFrame: 180 days
Other outcomes:
measure: Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins
timeFrame: 28 days
measure: Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins
timeFrame: 57 days
measure: Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins
timeFrame: 180 days
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