☆ 4.6 Article

Safety and immunogenicity of SARS-CoV-2 vaccines in Chinese patients with cirrhosis: a prospective multicenter study

HEPATOLOGY INTERNATIONAL (2022)

Journal

HEPATOLOGY INTERNATIONAL

Volume 16, Issue 3, Pages 691-701

Publisher

SPRINGER

DOI: 10.1007/s12072-022-10332-9

Keywords

Child-Pugh; Compensated cirrhosis; Coronavirus disease 2019; Decompensated cirrhosis; Hepatitis B virus; Immunogenicity; Safety; Severe acute respiratory syndrome coronavirus 2; Vaccine; Vaccination

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Abstract

This study examined the safety and immunogenicity of COVID-19 vaccination in patients with compensated and decompensated cirrhosis. The results showed that the vaccine was well tolerated with mostly mild and transient adverse events. Patients with Child-Pugh score of B and C levels had a weaker immune response to the vaccine.

Background Data on safety and immunogenicity of coronavirus disease 2019 (COVID-19) vaccination in patients with compensated (C-cirrhosis) and decompensated cirrhosis (D-cirrhosis) are limited. Methods In this prospective multicenter study, adult participants with C-cirrhosis and D-cirrhosis were enrolled and received two doses of inactivated whole-virion COVID-19 vaccines. Adverse events were recorded within 14 days after any dose of vaccination, and serum samples of enrolled patients were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. Risk factors for negative neutralizing antibody were analyzed. Results In total, 553 patients were enrolled from 15 centers in China, including 388 and 165 patients with C-cirrhosis and D-cirrhosis. The vaccines were well tolerated, most adverse reactions were mild and transient, and injection site pain (23/388 [5.9%] vs 9/165 [5.5%]) and fatigue (5/388 [1.3%] vs 3/165 [1.8%]) were the most frequently local and systemic adverse events in both the C-cirrhosis and D-cirrhosis groups. Overall, 4.4% (16/363) and 0.3% (1/363) of patients were reported Grades 2 and 3 alanine aminotransferase (ALT) elevations (defined as ALT > 2 upper limit of normal [ULN] but <= 5 ULN, and ALT > 5 ULN, respectively). The positive rates of COVID-19 neutralizing antibodies were 71.6% (278/388) and 66.1% (109/165) in C-cirrhosis and D-cirrhosis groups. Notably, Child-Pugh score of B and C levels was an independent risk factor of negative neutralizing antibody. Conclusions Inactivated COVID-19 vaccinations are safe with acceptable immunogenicity in cirrhotic patients, and Child-Pugh score of B and C levels is associated with hyporesponsive to COVID-19 vaccination.

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Coronavirus disease 2019 vaccines: landscape of global studies and potential risks

Hu-Da-Chuan Jiang, Yan-Yang Tao, Si-Yue Jia, Jing-Xin Li, Feng-Cai Zhu

Summary: With the outbreak of the COVID-19 pandemic, the importance of vaccines in epidemic prevention and public health has never been more apparent. Concerns have been raised over the effectiveness of current COVID-19 vaccines due to the emergence of multiple variants worldwide. This review discusses the characteristics and clinical trial results of COVID-19 vaccine candidates in different platforms, as well as future directions for research and development of the next generation of vaccines. Additionally, it summarizes serious adverse events reported recently after large-scale vaccination with current COVID-19 vaccines, including thromboembolism associated with the AstraZeneca and Johnson & Johnson vaccines.

CHINESE MEDICAL JOURNAL (2021)