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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-28

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Prospective Cohort Study of Metabolic Associated Fatty Liver Disease in China

NCT04573283

Metabolic Associated Fatty Liver Disease

RECRUITING

Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

NCT05560997

Non-Alcoholic Fatty Liver Disease Machine Learning

UNKNOWN

Fatty Liver Disease Collaborative Research in China

NCT02391168

Fatty Liver Fatty Liver, Alcoholic Non-alcoholic Fatty Liver Disease

UNKNOWN

The Potential Value and Impact of Diagnostic Biomarkers for MAFLD Using Machine Learning Methods

NCT06061640

Metabolic Dysfunction-associated Fatty Liver Disease

UNKNOWN

Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study

NCT03534908

NAFLD Cardiovascular Diseases

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Associated Fatty Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Recombinant protein vaccine

Recombinant protein vaccine and adenovirus vector vaccine

Intervention Type BIOLOGICAL

Administer recombinant protein vaccine and adenovirus vector vaccine

Adenovirus vector vaccine

Recombinant protein vaccine and adenovirus vector vaccine

Intervention Type BIOLOGICAL

Administer recombinant protein vaccine and adenovirus vector vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recombinant protein vaccine and adenovirus vector vaccine

Administer recombinant protein vaccine and adenovirus vector vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.