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NCT Number: NCT04883177

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of participants with adverse events within 7 days after each injection

    Time frame: up to 7 days after each injection

Secondary outcomes

  1. Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0

    Time frame: up to 28 days after each injection

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Collaborators

  • Affiliated Hospital of Yunnan University
  • Baoding People's Hospital
  • Beijing YouAn Hospital
  • Beilun Hospital of Traditional Chinese Medicine
  • First Affiliated Hospital of Chongqing Medical University
  • Fuling Central Hospital of Chongqing City
  • Henan Provincial People's Hospital
  • Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
  • Huashan Hospital
  • Jinchang Central Hospital
  • Jincheng People's Hospital
  • Jingzhou Central Hospital
  • LanZhou University
  • People's Hospital of Ningxia Hui Autonomous Region
  • Qingdao Sixth People's Hospital
  • Qingyang People's Hospital
  • Qishan Hospital of Yantai City
  • Shandong Provincial Hospital
  • Shanxi Bethune Hospital
  • Shenyang Sixth People's Hospital
  • The Central Hospital of Lishui City
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Xiamen University
  • The First People's Hospital of Taicang
  • The First People's Hospital of Yunnan
  • The Fourth Affiliated Hospital of Zhejiang University
  • The Third People's Hospital of Linfen City
  • The Third People's Hospital of Taiyuan
  • The Third People's Hospital of Tibet Autonomous Region
  • The Third People's Hospital of Zhenjiang City
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Tianjin Second People's Hospital
  • Tianjin Third Central Hospital
  • Wuhan Jinyintan Hospital
  • Wuxi Fifth People's Hospital
  • Xingtai People's Hospital
  • Yibin First People's Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 12, 2021
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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