NCT05738707

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

January 28, 2023

Last Update Submit

February 12, 2023

Conditions

Metabolic Associated Fatty Liver Disease

Keywords

SARS-CoV-2vaccinationimmune response

Outcome Measures

Primary Outcomes (3)

  • Dynamic monitoring of neutralizing antibody titers

    Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination

    28 days

  • Dynamic monitoring of neutralizing antibody titers

    Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination

    57 days

  • Dynamic monitoring of neutralizing antibody titers

    Dynamic monitoring of neutralizing antibody titers induced by SARS-CoV-2 vaccination

    180 days

Secondary Outcomes (3)

  • Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)

    28 days

  • Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)

    57 days

  • Dynamic monitoring of titers of antibodies (RBD, S1, S2 and ECD)

    180 days

Other Outcomes (3)

  • Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins

    28 days

  • Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins

    57 days

  • Dynamic monitoring of CD4+ and CD8+T cell responses to S, N, M, and E proteins

    180 days

Study Arms (2)

Recombinant protein vaccine

Biological: Recombinant protein vaccine and adenovirus vector vaccine

Adenovirus vector vaccine

Biological: Recombinant protein vaccine and adenovirus vector vaccine

Interventions

Recombinant protein vaccine and adenovirus vector vaccineBIOLOGICAL

Administer recombinant protein vaccine and adenovirus vector vaccine

Adenovirus vector vaccineRecombinant protein vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • Persons who failed to complete SARS-CoV-2 vaccination.
  • Start vaccination but do not strictly follow the vaccination schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jie Li, M.D., Ph.D

CONTACT

86-15863787910lijier@sina.com

Jian Wang

CONTACT

86-1306333526313063335263@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 22, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

February 22, 2023

Record last verified: 2023-02