Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study

JOURNAL OF HEPATOLOGY

卷:75

Article

Wang, Jitao^1,2,3  Hou, Zhiyun²  Liu, Jianxin⁴  Gu, Ye⁵  Wu, Yunhong⁶  Chen, Zhenhuai⁷  Ji, Jiansong⁸  Diao, Shiqi⁹  Qiu, Yuanwang¹⁰  Zou, Shengqiang¹¹  Zhang, Aiguo²  Zhang, Nina²  Wang, Fengxian⁴  Li, Xue⁴  Wang, Yan⁵  Liu, Xing⁵  Lv, Cheng³  Chen, Shubo³  Liu, Dengxiang³  Ji, Xiaolin³  Liu, Chao⁶  Ren, Tao⁶  Sun, Jingwei⁷  Zhao, Zhongwei⁸  Wu, Fazong⁸  Li, Fenxiang⁹  Wang, Ruixu⁹  Yan, Yan¹⁰  Zhang, Shiliang¹⁰  Ge, Guohong¹¹  Shao, Jiangbo¹¹  Yang, Shiying¹²  Liu, Chuan¹  Huang, Yifei¹  Xu, Dan¹  Li, Xiaoguo¹  Ai, Jingwen¹³  He, Qing¹⁴  Zheng, Ming-Hua¹⁵  Zhang, Liting¹²  Xie, Qing¹⁶  Rockey, Don C.¹⁷  Fallowfield, Jonathan A.¹⁸  Zhang, Wenhong¹³  Qi, Xiaolong¹ 

[1] Lanzhou Univ, Hosp 1, Inst Portal Hypertens, CHESS Ctr, Lanzhou, Peoples R China

[2] Jincheng Peoples Hosp, CHESS COVID 19 Grp, Jincheng, Peoples R China

[3] Xingtai Peoples Hosp, CHESS COVID 19 Grp, Xingtai, Peoples R China

[4] Jinzhou Cent Hosp, CHESS COVID 19 Grp, Jinzhou, Peoples R China

[5] Sixth Peoples Hosp Shenyang City, CHESS COVID 19 Grp, Shenyang, Peoples R China

[6] Peoples Govt Tibet Autonomous Reg, Hosp Chengdu Off, CHESS COVID 19 Grp, Chengdu, Peoples R China

[7] Baoding Peoples Hosp, CHESS COVID 19 Grp, Baoding, Peoples R China

[8] Lishui Cent Hosp, CHESS COVID 19 Grp, Lishui, Peoples R China

[9] Third Peoples Hosp Linfen City, CHESS COVID 19 Grp, Linfen, Shanxi, Peoples R China

[10] Jiangnan Univ, Peoples Hosp Wuxi 5, Affiliated Hosp, CHESS COVID 19 Grp, Wuxi, Jiangsu, Peoples R China

[11] Third Peoples Hosp Zhenjiang City, CHESS COVID 19 Grp, Zhenjiang, Jiangsu, Peoples R China

[12] Lanzhou Univ, Hosp 1, Dept Hepatol, Lanzhou, Peoples R China

[13] Fudan Univ, Huashan Hosp, Dept Infect Dis, Shanghai, Peoples R China

[14] Third Peoples Hosp Shenzhen, Natl Clin Res Ctr Infect Dis, Shenzhen, Peoples R China

[15] Wenzhou Med Univ, Affiliated Hosp 1, NAFLD Res Ctr, Dept Hepatol, Wenzhou, Peoples R China

[16] Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Infect Dis, Shanghai, Peoples R China

[17] Med Univ South Carolina, Digest Dis Res Ctr, Charleston, SC 29425 USA

[18] Univ Edinburgh, Ctr Inflammat Res, Edinburgh, Midlothian, Scotland

DOI  :  10.1016/j.jhep.2021.04.026

来源: Elsevier

【 摘 要 】

Background & Aims: The development of COVID-19 vaccines has progressed with encouraging safety and efficacy data. Concerns have been raised about SARS-CoV-2 vaccine responses in the large population of patients with non-alcoholic fatty liver disease (NAFLD). The study aimed to explore the safety and immunogenicity of COVID-19 vaccination in NAFLD. Methods: This multicenter study included patients with NAFLD without a history of SARS-CoV-2 infection. All patients were vaccinated with 2 doses of inactivated vaccine against SARS-CoV-2. The primary safety outcome was the incidence of adverse reactions within 7 days after each injection and overall incidence of adverse reactions within 28 days, and the primary immunogenicity outcome was neutralizing antibody response at least 14 days after the whole-course vaccination. Results: A total of 381 patients with pre-existing NAFLD were included from 11 designated centers in China. The median age was 39.0 years (IQR 33.0-48.0 years) and 179 (47.0%) were male. The median BMI was 26.1 kg/m(2) (IQR 23.8-28.1 kg/m(2)). The number of adverse reactions within 7 days after each injection and adverse reactions within 28 days totaled 95 (24.9%) and 112 (29.4%), respectively. The most common adverse reactions were injection site pain in 70 (18.4%), followed by muscle pain in 21 (5.5%), and headache in 20 (5.2%). All adverse reactions were mild and self-limiting, and no grade 3 adverse reactions were recorded. Notably, neutralizing antibodies against SARS-CoV-2 were detected in 364 (95.5%) patients with NAFLD. The median neutralizing antibody titer was 32 (IQR 864), and the neutralizing antibody titers were maintained. Conclusions: The inactivated COVID-19 vaccine appears to be safe with good immunogenicity in patients with NAFLD. Lay summary: The development of vaccines against coronavirus disease 2019 (COVID-19) has progressed rapidly, with encouraging safety and efficacy data. This study now shows that the inactivated COVID-19 vaccine appears to be safe with good immunogenicity in the large population of patients with nonalcoholic fatty liver disease. (C) 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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