Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases (SIMPLE)

August 12, 2021 updated by: The Second Affiliated Hospital of Chongqing Medical University

Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver （CQMU）

On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with chronic liver diseases, and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as autoimmune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 / influenza vaccine can effectively prevent COVID-19 / influenza virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 / influenza vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, liver function, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and patients with chronic liver disease before and after vaccination ( 1, 3, 6, 12 months after vaccination). The adverse reactions related to the vaccine were recorded.

Study Type

Observational

Enrollment (Anticipated)

2000

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

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Contact:

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic liver disease vaccinated with SARS-Cov-2 vaccine.

Description

Inclusion Criteria:

  1. Healthy group were as follows: no history of hepatitis, no history of liver cirrhosis, no history of liver cancer and receiving the whole-course COVID-19 vaccination.
  2. Patients with chronic liver disease diagnosed clinically or pathologically and receiving the whole-course COVID-19 vaccination.

Exclusion Criteria:

  1. Patients previously diagnosed or with a history of contact with confirmed cases
  2. Patients with contraindications for vaccination.

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
Chronic Liver Diseases Patients/Healthy People
Chronic hepatitis (B OR C) , autoimmune hepatitis, liver cirrhosis, primary hepatocellular carcinoma
Biological: SARS-COV-2 VACCINE
the antibody titer and adverse reactions were observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events after injection.
Time Frame: 4 weeks after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
4 weeks after vaccination
Number of participants with adverse events after injection.
Time Frame: 12 weeks after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
12 weeks after vaccination
Number of participants with adverse events after injection.
Time Frame: 24 weeks after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
24 weeks after vaccination
Number of participants with adverse events after injection.
Time Frame: 48 weeks after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
48 weeks after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Titer and duration of COVID-19 antibody production after vaccination
Time Frame: 4 weeks after vaccination
The titer and duration of COVID-19 antibody were produced at 4 weeks
4 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
Time Frame: 12 weeks after vaccination
The titer and duration of COVID-19 antibody were produced at 12 weeks
12 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
Time Frame: 24 weeks after vaccination
The titer and duration of COVID-19 antibody were produced at 24 weeks
24 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
Time Frame: 48 weeks after vaccination
The titer and duration of COVID-19 antibody were produced at 48 weeks after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with chronic liver disease.
48 weeks after vaccination

Collaborators and Investigators

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

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

July 1, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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