Safety and Immunogenicity of SARS-CoV-2 Vaccines in Patients With Chronic Liver Diseases (CHESS-NMCID 2101): A Multicenter Study

作者全名："Ai, Jingwen; Wang, Jitao; Liu, Dengxiang; Xiang, Huiling; Guo, Ying; Lv, Jiaojian; Zhang, Qiran; Li, Jinlong; Zhang, Xiaochong; Li, Qianqian; Liang, Jing; Guo, Xiaoqing; Feng, Yinong; Liu, Luxiang; Zhang, Xuying; Qin, Wei; Wang, Xiaodong; Rao, Wei; Zhang, Qun; Tian, Qiuju; Zhang, Yanliang; Xie, Faren; Jiang, Shujun; Yan, Yan; Qiu, Yuanwang; Wu, Hangyuan; Hou, Zhiyun; Zhang, Nina; Zhang, Aiguo; Ji, Jiansong; Yang, Jie; Huang, Jiansheng; Zhao, Zhongwei; Gu, Ye; Bian, Li; Zhang, Zhen; Zou, Shengqiang; Ji, Hailei; Ge, Guohong; Du, Xiufang; Hou, Aifang; Zhu, Ying; Cong, Qingwei; Xu, Juan; Zu, Hongmei; Wang, Yun; Yan, Zhaolan; Yan, Xiaosong; BianBa, Yangzhen; Ci, Qu; Zhang, Liting; Yang, Shiying; Gao, Xiaoqin; Zhong, Li; He, Song; Liu, Chuan; Huang, Yifei; Liu, Yanna; Xu, Dan; Zhu, Qingliang; Xu, Xinxin; Lv, Muhan; Zhang, Wenhong; Qi, Xiaolong"

作者地址："[Ai, Jingwen; Zhang, Qiran; Zhang, Wenhong] Fudan Univ, Huashan Hosp, Shanghai Med Coll,Dept Infect Dis, Natl Med Ctr Infect Dis,Shanghai Key Lab Infect D, Shanghai, Peoples R China; [Wang, Jitao; Liu, Chuan; Huang, Yifei; Xu, Dan; Qi, Xiaolong] First Hosp Lanzhou Univ, Xingtai Peoples Hosp, CHESS Ctr, Inst Portal Hypertens, Lanzhou, Gansu, Peoples R China; [Wang, Jitao; Liu, Dengxiang; Li, Jinlong; Zhang, Xiaochong] Xingtai Peoples Hosp, CHESS COVID 19 Grp, Xingtai, Heibei, Peoples R China; [Xiang, Huiling; Li, Qianqian; Liang, Jing] Third Cent Hosp Tianjin, Dept Hepatol & Gastroenterol, Tianjin, Peoples R China; [Guo, Ying; Guo, Xiaoqing; Feng, Yinong] Third Peoples Hosp Taiyuan, Dept Hepatol, Taiyuan, Shanxi, Peoples R China; [Lv, Jiaojian; Liu, Luxiang] Lishui Peoples Hosp, Dept Infect Dis, Lishui, Zhejiang, Peoples R China; [Zhang, Xuying] Lishui Peoples Hosp, Clinal Lab, Lishui, Zhejiang, Peoples R China; [Qin, Wei; Wang, Xiaodong] Baoding Peoples Hosp, Dept Gastroenterol, Baoding, Heibei, Peoples R China; [Rao, Wei; Zhang, Qun; Tian, Qiuju] Qingdao Univ, Liver Dis Ctr, Div Hepatol, Affiliated Hosp, Qingdao, Shandong, Peoples R China; [Zhang, Yanliang; Xie, Faren; Jiang, Shujun] Nanjing Univ Chinese Med, Dept Infect Dis, Nanjing Hosp Chinese Med, Nanjing, Jiangsu, Peoples R China; [Yan, Yan; Qiu, Yuanwang; Wu, Hangyuan] Jiangnan Univ, CHESS COVID 19 Grp, Peoples Hosp Wuxi Affiliated Hosp 5, Wuxi, Jiangsu, Peoples R China; [Hou, Zhiyun; Zhang, Nina; Zhang, Aiguo] Jincheng Peoples Hosp, Dept Hepatobiliary Surg, Jincheng, Shanxi, Peoples R China; [Ji, Jiansong; Yang, Jie; Huang, Jiansheng; Zhao, Zhongwei] Zhejiang Univ, Lishui Hosp, CHESS COVID 19 Grp, Lishui, Zhejiang, Peoples R China; [Gu, Ye; Bian, Li; Zhang, Zhen] Sixth Peoples Hosp Shenyang, CHESS COVID 19 Grp, Shenyang, Liaoning, Peoples R China; [Zou, Shengqiang; Ji, Hailei; Ge, Guohong] Jiangsu Univ, Dept Hepatol, Zhenjiang Hosp 3, Zhenjiang, Jiangsu, Peoples R China; [Du, Xiufang; Hou, Aifang] Third Peoples Hosp Linfen City, Dept Liver Dis, Linfen, Shanxi, Peoples R China; [Zhu, Ying; Cong, Qingwei; Xu, Juan] Dalian Med Univ, Liver Dis Ctr Integrated Tradit Chinese & Western, Dept Infect Dis, Affiliated Hosp 1, Dalian, Liaoning, Peoples R China; [Zu, Hongmei; Wang, Yun; Yan, Zhaolan] Fourth Peoples Hosp Qinghai Prov, Dept Gastroenterol, Xining, Qinghai, Peoples R China; [Yan, Xiaosong; BianBa, Yangzhen; Ci, Qu] Third Peoples Hosp Tibet Autonomous Reg, CHESS COVID 19 Grp, Lhasa, Tibet Autonomou, Peoples R China; [Zhang, Liting; Yang, Shiying; Gao, Xiaoqin] First Hosp Lanzhou Univ, Dept Infect Dis, Lanzhou, Gansu, Peoples R China; [Zhong, Li; He, Song] Chongqing Med Univ, Dept Gastroenterol, Affiliated Hosp 2, Chongqing, Peoples R China; [Liu, Yanna] Peking Univ, Dept Microbiol, Sch Basic Med Sci, Hlth Sci Ctr, Beijing, Peoples R China; [Liu, Yanna] Peking Univ, Infect Dis Ctr, Sch Basic Med Sci, Hlth Sci Ctr, Beijing, Peoples R China; [Zhu, Qingliang; Xu, Xinxin; Lv, Muhan] Southwest Med Univ, Dept Gastroenterol, Affiliated Hosp, Luzhou, Sichuan, Peoples R China"

通信作者："Qi, XL (通讯作者)，First Hosp Lanzhou Univ, Med, Lanzhou, Peoples R China.; Qi, XL (通讯作者)，First Hosp Lanzhou Univ, Portal Hypertens Alliance China CHESS, Lanzhou, Peoples R China.; Qi, XL (通讯作者)，First Hosp Lanzhou Univ, Inst Portal Hypertens, Lanzhou, Peoples R China.; Zhang, WH (通讯作者)，Fudan Univ, Med, Huashan Hosp, Shanghai, Peoples R China.; Zhang, WH (通讯作者)，Fudan Univ, Natl Med Ctr Infect Dis NMCID, Huashan Hosp, Shanghai, Peoples R China.; Zhang, WH (通讯作者)，Fudan Univ, Dept Infect Dis, Huashan Hosp, Shanghai, Peoples R China."

来源：CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000862693200024

JCR分区：Q1

影响因子：12.6

年份：2022

卷号：20

期号：7

开始页：1516

结束页：+

文献类型：Article

关键词：Chronic Liver Diseases; Cirrhosis; Immunogenicity; Safety; SARS-CoV-2 Vaccines

摘要："BACKGROUND & AIMS: We aimed to assess the safety and immunogenicity of inactivated whole-virion severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with chronic liver diseases (CLD) in this study. METHODS: This was a prospective, multi-center, open-label study. Participants aged over 18 years with confirmed CLD and healthy volunteers were enrolled. All participants received 2 doses of inactivated whole-virion SARS-CoV-2 vaccines. Adverse reactions were recorded within 14 days after any dose of SARS-CoV-2 vaccine, laboratory testing results were collected after the second dose, and serum samples of enrolled subjects were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. RESULTS: A total of 581 participants (437 patients with CLD and 144 healthy volunteers) were enrolled from 15 sites in China. Most adverse reactions were mild and transient, and injection site pain (n=36; 8.2%) was the most frequently reported adverse event. Three participants had grade 3 aminopherase elevation (defined as alanine aminopherase >5 upper limits of normal) after the second dose of inactivated whole-virion SARS-CoV-2 vaccination, and only 1 of them was judged as severe adverse event potentially related to SARS-CoV-2 vaccination. The positive rates of SARS-CoV-2 neutralizing antibodies were 76.8% in the noncirrhotic CLD group, 78.9% in the compensated cirrhotic group, 76.7% in the decompensated cirrhotic group (P=.894 among CLD subgroups), and 90.3% in healthy controls (P=.008 vs CLD group). CONCLUSION: Inactivated whole-virion SARS-CoV-2 vaccines are safe in patients with CLD. Patients with CLD had lower immunologic response to SARS-CoV-2 vaccines than healthy population. The immunogenicity is similarly low in noncirrhotic CLD, compensated cirrhosis, and decompensated cirrhosis."

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