COVID-19 Vaccines in Patients With Chronic Liver Disease

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

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.

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.

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.