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.
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
OBSERVATIONAL
Enrollment
1,000
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing You'an Hospital
Beijing, Beijing Municipality, China
Chongqing Fuling Central Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Number of participants with adverse events within 7 days after each injection
Time frame: up to 7 days after each injection
Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0
Time frame: 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
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
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
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
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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
...and 27 more locations