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


ABSTRACT:

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.

SUBMITTER: Wang J 

PROVIDER: S-EPMC8995697 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Wang Jitao J   Zhang Qiran Q   Ai Jingwen J   Liu Dengxiang D   Liu Chuan C   Xiang Huiling H   Gu Ye Y   Guo Ying Y   Lv Jiaojian J   Huang Yifei Y   Liu Yanna Y   Xu Dan D   Chen Shubo S   Li Jinlong J   Li Qianqian Q   Liang Jing J   Bian Li L   Zhang Zhen Z   Guo Xiaoqing X   Feng Yinong Y   Liu Luxiang L   Zhang Xuying X   Zhang Yanliang Y   Xie Faren F   Jiang Shujun S   Qin Wei W   Wang Xiaodong X   Rao Wei W   Zhang Qun Q   Tian Qiuju Q   Zhu Ying Y   Cong Qingwei Q   Xu Juan J   Hou Zhiyun Z   Zhang Nina N   Zhang Aiguo A   Zu Hongmei H   Wang Yun Y   Yan Zhaolan Z   Du Xiufang X   Hou Aifang A   Yan Yan Y   Qiu Yuanwang Y   Wu Hangyuan H   Hu Shengjuan S   Deng Yanhong Y   Ji Jiansong J   Yang Jie J   Huang Jiansheng J   Zhao Zhongwei Z   Zou Shengqiang S   Ji Hailei H   Ge Guohong G   Zhong Li L   He Song S   Yan Xiaosong X   Yangzhen Bian Ba BB   Qu Ci C   Zhang Liting L   Yang Shiying S   Gao Xiaoqin X   Lv Muhan M   Zhu Qingliang Q   Xu Xinxin X   Zeng Qing-Lei QL   Qi Xiaolong X   Zhang Wenhong W  

Hepatology international 20220409 3


<h4>Background</h4>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.<h4>Methods</h4>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 pat  ...[more]

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