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

February 12, 2023 updated by: Jie Li, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jie Li, M.D., Ph.D
  • Phone Number: 86-15863787910
  • Email: lijier@sina.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recombinant protein vaccine
Biological: Recombinant protein vaccine and adenovirus vector vaccine
Administer recombinant protein vaccine and adenovirus vector vaccine
Adenovirus vector vaccine
Biological: Recombinant protein vaccine and adenovirus vector vaccine
Administer recombinant protein vaccine and adenovirus vector vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic monitoring of neutralizing antibody titers
Time Frame: 28 days
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
28 days
Dynamic monitoring of neutralizing antibody titers
Time Frame: 57 days
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
57 days
Dynamic monitoring of neutralizing antibody titers
Time Frame: 180 days
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)
Time Frame: 28 days
Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) against different spike protein antigens of SARS-CoV-2 vaccination
28 days
Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)
Time Frame: 57 days
Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) against different spike protein antigens of SARS-CoV-2 vaccination
57 days
Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)
Time Frame: 180 days
Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD) against different spike protein antigens of SARS-CoV-2 vaccination
180 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins
Time Frame: 28 days
Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins induced by SARS-CoV-2 vaccination
28 days
Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins
Time Frame: 57 days
Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins induced by SARS-CoV-2 vaccination
57 days
Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins
Time Frame: 180 days
Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins induced by SARS-CoV-2 vaccination
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

February 1, 2026

Study Registration Dates

First Submitted

January 28, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Estimate)

February 22, 2023

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-128

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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