Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study
Jitao Wang, Zhiyun Hou, Jianxin Liu, Ye Gu, Yunhong Wu, Zhenhuai Chen, Jiansong Ji, Shiqi Diao, Yuanwang Qiu, Shengqiang Zou, Aiguo Zhang, Nina Zhang, Fengxian Wang, Xue Li, Yan Wang, Xing Liu, Cheng Lv, Shubo Chen, Dengxiang Liu, Xiaolin Ji, Chao Liu, Tao Ren, Jingwei Sun, Zhongwei Zhao, Fazong Wu, Fenxiang Li, Ruixu Wang, Yan Yan, Shiliang Zhang, Guohong Ge, Jiangbo Shao, Shiying Yang, Chuan Liu, Yifei Huang, Dan Xu, Xiaoguo Li, Jingwen Ai, Qing He, Ming-Hua Zheng, Liting Zhang, Qing Xie, Don C Rockey, Jonathan A Fallowfield, Wenhong Zhang, Xiaolong Qi, Jitao Wang, Zhiyun Hou, Jianxin Liu, Ye Gu, Yunhong Wu, Zhenhuai Chen, Jiansong Ji, Shiqi Diao, Yuanwang Qiu, Shengqiang Zou, Aiguo Zhang, Nina Zhang, Fengxian Wang, Xue Li, Yan Wang, Xing Liu, Cheng Lv, Shubo Chen, Dengxiang Liu, Xiaolin Ji, Chao Liu, Tao Ren, Jingwei Sun, Zhongwei Zhao, Fazong Wu, Fenxiang Li, Ruixu Wang, Yan Yan, Shiliang Zhang, Guohong Ge, Jiangbo Shao, Shiying Yang, Chuan Liu, Yifei Huang, Dan Xu, Xiaoguo Li, Jingwen Ai, Qing He, Ming-Hua Zheng, Liting Zhang, Qing Xie, Don C Rockey, Jonathan A Fallowfield, Wenhong Zhang, Xiaolong Qi
Abstract
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/m2 (IQR 23.8-28.1 kg/m2). 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 8-64), 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 non-alcoholic fatty liver disease.
Conflict of interest statement
Conflicts of interest The authors have declared no conflict of interest related to the study. Please refer to the accompanying ICMJE disclosure forms for further details.
Copyright © 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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Source: PubMed