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

Completed

• Conditions: Liver Disease; COVID-19; Vaccine Reaction

• Registration Number: NCT04883177
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-04-29
• Study Start: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-12
• Primary Completion: 2022-01-01
• Study Completion: 2022-05-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events within 7 days after each injection	up to 7 days after each injection

Secondary Outcome Measures

Name	Time	Method
Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0	up to 28 days after each injection
Neutralizing antibody titers in blood samples after 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	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 serological conversion rate in populations with liver disease after COVID-19 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	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

Trial Locations

Locations (37)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing You'an Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing Fuling Central Hospital; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Jinchang Central Hospital; 🇨🇳 Jinchang, Gansu, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Qingyang People's Hospital; 🇨🇳 Qingyang, Gansu, China

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Xingtai People's Hospital; 🇨🇳 Xingtai, Hebei, China

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