COVID-19 Vaccines in Patients With Chronic Liver Disease

Study Overview
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Brief Summary
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.

Detailed Description
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This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Official Title
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Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study

Conditions
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Liver Disease Chronic

Intervention / Treatment
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* Biological: COVID-19 Vaccines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Serum ALT and AST are both ≤ 80 U/L. HIV and TPHA screening were negative. Body temperature ≤37.0℃. Exclusion Criteria: Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/B scan). Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy. Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months. Patients with cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs. Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.c. Patients with urticaria within a year. Patients with coagulation disorder. Faintng during acupuncture treatment . Patients who received other investigational drugs within one month. Be receiving anti-TB treatment. Other conditions determined by the researcher.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 doses of vaccine<br>Covid-19 vaccination on day 0, day 25±3, and 6 months after the second dose , respectively，and follow up one and half a year | Biological: COVID-19 Vaccines<br>* One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.<br>|
| Experimental: 1 dose of the third vaccination<br>One dose of COVID-19 vaccine and 1 year of follow-up | Biological: COVID-19 Vaccines<br>* One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of coronavirus vaccine | Rate of adverse effects after COVID-19 vaccination | Within 2 months after the first dose of COVID-19 vaccination | 
| Immunogenicity of coronavirus vaccine | Detected the dynamics and titers of anti-SARS-CoV-2 antibodies | Within 2 months after the first dose of COVID-19 vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of coronavirus vaccine | Rate of adverse effects after COVID-19 vaccination | Within 18 months after the first dose of COVID-19 vaccination | 
| Immunogenicity of coronavirus vaccine | Detected the dynamics and titers of anti-SARS-CoV-2 antibodies | Within 18 months after the first dose of COVID-19 vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Disease Chronic, COVID-19 vaccination