Metabolic Associated Fatty Liver DiseaseNCT05738707
Clinical Study of SARS-CoV-2 Vaccine in Metabolism-related Fatty Liver Disease
An observational study of Metabolic Associated Fatty Liver Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Associated Fatty Liver Disease
- What is being tested?
- Recombinant protein vaccine and adenovirus vector vaccine
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Strengthened by the third dose of SARS-CoV-2 vaccination in MAFDL population.
- Age ≥18 years old, gender unlimited.
- Persons who agree to participate in this clinical trial and sign informed consent voluntarily.
Who cannot join
- Persons who failed to complete SARS-CoV-2 vaccination.
- Start vaccination but do not strictly follow the vaccination schedule.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Associated Fatty Liver Disease
- Being tested
- Recombinant protein vaccine and adenovirus vector vaccine
- Keywords
- SARS-CoV-2, vaccination, immune response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant protein vaccine and adenovirus vector vaccineBiological
Administer recombinant protein vaccine and adenovirus vector vaccine
| Study group | Role | What they receive |
|---|---|---|
| Recombinant protein vaccine | Not described Receives: Biological: Recombinant protein vaccine and adenovirus vector vaccine | |
| Adenovirus vector vaccine | Not described Receives: Biological: Recombinant protein vaccine and adenovirus vector vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic monitoring of neutralizing antibody titers
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
Measured: 28 days
Dynamic monitoring of neutralizing antibody titers
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
Measured: 57 days
Dynamic monitoring of neutralizing antibody titers
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
Measured: 180 days
Secondary outcomes (3)
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
Measured: 28 days
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
Measured: 57 days
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
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Li, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738707
- Sponsor's protocol ID
- 2023-128
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of SARS-CoV-2 Vaccine Sequentially Enhancing Immune Response in Metabolism-related Fatty Liver Disease Based on Deep Machine Learning
- ClinicalTrials.gov ID
- NCT05738707
- Acronym / sponsor ID
- 2023-128
- Conditions
- Metabolic Associated Fatty Liver Disease
- Keywords
- SARS-CoV-2, vaccination, immune response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant protein vaccine | – | Biological: Recombinant protein vaccine and adenovirus vector vaccine |
| Adenovirus vector vaccine | – | Biological: Recombinant protein vaccine and adenovirus vector vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Strengthened by the third dose of SARS-CoV-2 vaccination in MAFDL population.
- Age ≥18 years old, gender unlimited.
- Persons who agree to participate in this clinical trial and sign informed consent voluntarily.
Key exclusion criteria (2 listed)
- Persons who failed to complete SARS-CoV-2 vaccination.
- Start vaccination but do not strictly follow the vaccination schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant protein vaccine and adenovirus vector vaccineAdminister recombinant protein vaccine and adenovirus vector vaccine | Biological | Adenovirus vector vaccine, Recombinant protein vaccine |
Primary outcome
Dynamic monitoring of neutralizing antibody titers
Time frame: 28 days
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
Dynamic monitoring of neutralizing antibody titers
Time frame: 57 days
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
Dynamic monitoring of neutralizing antibody titers
Time frame: 180 days
Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination
3 secondary outcomes
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)
Time frame: 57 days
Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Associated Fatty Liver Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, M.D., Ph.D (86-15863787910, lijier@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic monitoring of neutralizing antibody titers (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.