Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101)

April 23, 2023 updated by: Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101): a Multicenter Cohort Study

COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver disease are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. Therefore, early inoculation of SARS-CoV-2 vaccine in patients with liver disease is an important protective measure. However, information on the effectiveness and safety of the COVID-19 vaccine for liver disease remains to be determined. This muilticentre study (CHESS2101) aims to study the effectiveness and safety of the COVID-19 vaccination for patients with liver disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Patients with liver disease, especially liver cirrhosis, hepatobiliary malignancies, candidates for liver transplantation, and individuals who are immunosuppressed after liver transplantation, have an increased risk of COVID-19 infection and increased mortality. Therefore, early inoculation of SARS-CoV-2 vaccine in liver disease patients is an important protective measure. A small number of SARS-CoV-2 vaccines have been tested in clinical trials in healthy individuals and have evidence of short-term safety, immunogenicity and efficacy. However, information on the effectiveness and safety of the COVID-19 vaccine for patients with liver disease remains to be determined. This muilticentre study (CHESS2101) aims to study the effectiveness and safety of the COVID-19 vaccination for patients with liver disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China
        • Beijing You'an Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China
        • Chongqing Fuling Central Hospital
    • Fujian
      • Xiamen, Fujian, China
        • The First Affiliated Hospital of Xiamen University
    • Gansu
      • Jinchang, Gansu, China
        • Jinchang Central Hospital
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
      • Qingyang, Gansu, China
        • Qingyang People's Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • The third affiliated hospital of Sun Yat-Sen University
    • Hebei
      • Xingtai, Hebei, China
        • Xingtai People's Hospital
    • Heibei
      • Baoding, Heibei, China
        • Baoding People's Hospital
    • Henan
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, China
        • WuHan Jinyintan Hospital
    • Jiangsu
      • Taicang, Jiangsu, China
        • The First People's Hospital of Taicang
      • Wuxi, Jiangsu, China
        • Wuxi Fifth People's Hospital
      • Zhenjiang, Jiangsu, China
        • The Affiliated Third Hospital of Jiangsu University
    • Liaoning
      • Jinzhou, Liaoning, China
        • Jinzhou Central Hospital
      • Shenyang, Liaoning, China
        • Sixth People's Hospital of Shenyang
    • Ningxia Hui Autonomous Region
      • Yinchuan, Ningxia Hui Autonomous Region, China
        • People's Hospital of Ningxia Hui Autonomous Region
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Hospital
      • Qingdao, Shandong, China
        • Qingdao Sixth People's Hospital
      • Yantai, Shandong, China
        • Qishan Hospital of Yantai City
    • Shanghai
      • Shanghai, Shanghai, China
        • Huashan Hospital Affiliated to Fudan University
    • Shanxi
      • Jincheng, Shanxi, China
        • Jincheng People's Hospital
      • Linfen, Shanxi, China
        • The Third People's Hospital of Linfen City
      • Taiyuan, Shanxi, China
        • Shanxi Bethune Hospital
      • Taiyuan, Shanxi, China
        • Taiyuan Third People's Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
      • Yibin, Sichuan, China
        • Yibin First People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Second People's Hospital
      • Tianjin, Tianjin, China
        • Tianjin Third Central Hospital
    • Tibet
      • Lasa, Tibet, China
        • The Third People's Hospital of Tibet Autonomous Region
    • Yunnan
      • Kunming, Yunnan, China
        • The First People's Hospital of Yunnan Province
      • Kunming, Yunnan, China
        • Affiliated Hospital of Yunnan University
    • Zhejiang
      • Lishui, Zhejiang, China
        • The Central Hospital of Lishui City
      • Ningbo, Zhejiang, China
        • Beilun Hospital of Traditional Chinese Medicine
      • Yiwu, Zhejiang, China
        • the Fourth Affiliated Hospital of Zhejiang University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Populations With Liver Disease who Complete the whole-course COVID-19 vaccination

Description

Inclusion Criteria:

  1. Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver disease, cirrhosis, liver cancer, liver transplant subjects, etc.;
  2. Receiving the whole-course COVID-19 vaccination for 14 days or more;
  3. Volunteer to participate in this study.

Exclusion Criteria:

  1. Younger than 18 years old;
  2. Women during pregnancy or lactation;
  3. Research on other situations deemed unsuitable for selection.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with adverse events within 7 days after each injection
Time Frame: up to 7 days after each injection
up to 7 days after each injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0
Time Frame: up to 28 days after each injection
up to 28 days after each injection
Antibody serological conversion rate in populations with liver disease after COVID-19 vaccination
Time Frame: the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
Neutralizing antibody titers in blood samples after vaccination
Time Frame: the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
Antibody IgM titers in blood samples after vaccination
Time Frame: the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
Antibody IgG titers in blood samples after vaccination
Time Frame: the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hepatopancreatobiliary Surgery Institute of Gansu Province

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Anhui Medical University
LanZhou University
Beijing YouAn Hospital
Huashan Hospital
Shandong Provincial Hospital
Henan Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Tianjin Third Central Hospital
The Central Hospital of Lishui City
First Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Xiamen University
The First People's Hospital of Yunnan
The First People's Hospital of Taicang
Tianjin Second People's Hospital
People's Hospital of Ningxia Hui Autonomous Region
The Third People's Hospital of Taiyuan
The Third People's Hospital of Linfen City
Shanxi Bethune Hospital
Jingzhou Central Hospital
Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
Jincheng People's Hospital
Fuling Central Hospital of Chongqing City
Baoding People's Hospital
The Third People's Hospital of Tibet Autonomous Region
The Sixth People's Hospital of Shenyang City
Xingtai City People's Hospital
Jinchang Central Hospital
The Third People's Hospital of Zhenjiang City
Wuhan Jinyintan Hospital
Yibin First People's Hospital
Wuxi Fifth People's Hospital
Qingyang People's Hospital
Beilun Hospital of Traditional Chinese Medicine
Qingdao Sixth People's Hospital
Qishan Hospital of Yantai City
Affiliated Hospital of Yunnan University
The Fourth Affiliated Hospital of Zhejiang 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHESS2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings