Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101)
- Conditions
- Liver DiseaseCOVID-19Vaccine 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- 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.
- Younger than 18 years old;
- Women during pregnancy or lactation;
- 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 Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Wuhan Jinyintan Hospital
🇨🇳Wuhan, Hubei, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Affiliated Hospital of Yunnan University
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Beijing You'an Hospital
🇨🇳Beijing, Beijing, China
Chongqing Fuling Central Hospital
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Jinchang Central Hospital
🇨🇳Jinchang, Gansu, China
Qingyang People's Hospital
🇨🇳Qingyang, Gansu, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
Baoding People's Hospital
🇨🇳Baoding, Heibei, China
Wuxi Fifth People's Hospital
🇨🇳Wuxi, Jiangsu, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The First People's Hospital of Taicang
🇨🇳Taicang, Jiangsu, China
The Affiliated Third Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
People's Hospital of Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia Hui Autonomous Region, China
Jinzhou Central Hospital
🇨🇳Jinzhou, Liaoning, China
Sixth People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Qingdao Sixth People's Hospital
🇨🇳Qingdao, Shandong, China
Qishan Hospital of Yantai City
🇨🇳Yantai, Shandong, China
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Jincheng People's Hospital
🇨🇳Jincheng, Shanxi, China
The Third People's Hospital of Linfen City
🇨🇳Linfen, Shanxi, China
Taiyuan Third People's Hospital
🇨🇳Taiyuan, Shanxi, China
Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
🇨🇳Chengdu, Sichuan, China
Yibin First People's Hospital
🇨🇳Yibin, Sichuan, China
Tianjin Second People's Hospital
🇨🇳Tianjin, Tianjin, China
The Third People's Hospital of Tibet Autonomous Region
🇨🇳Lasa, Tibet, China
Tianjin Third Central Hospital
🇨🇳Tianjin, Tianjin, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
Beilun Hospital of Traditional Chinese Medicine
🇨🇳Ningbo, Zhejiang, China
The Central Hospital of Lishui City
🇨🇳Lishui, Zhejiang, China
The Fourth Affiliated Hospital of Zhejiang University
🇨🇳Yiwu, Zhejiang, China