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

Autor:	Ai J; Department of Infectious Diseases, National Medical Center for Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, Shanghai, China., Wang J; CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, Gansu, China; CHESS-COVID-19 Group, Xingtai People's Hospital, Xingtai, Heibei, China., Liu D; CHESS-COVID-19 Group, Xingtai People's Hospital, Xingtai, Heibei, China., Xiang H; Department of Hepatology and Gastroenterology, The Third Central Hospital of Tianjin, Tianjin, China., Guo Y; Department of Hepatology, The Third People's Hospital of Taiyuan, Taiyuan, Shanxi, China., Lv J; Department of Infectious Diseases, Lishui People's Hospital, Lishui, Zhejiang, China., Zhang Q; Department of Infectious Diseases, National Medical Center for Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, Shanghai, China., Li J; CHESS-COVID-19 Group, Xingtai People's Hospital, Xingtai, Heibei, China., Zhang X; CHESS-COVID-19 Group, Xingtai People's Hospital, Xingtai, Heibei, China., Li Q; Department of Hepatology and Gastroenterology, The Third Central Hospital of Tianjin, Tianjin, China., Liang J; Department of Hepatology and Gastroenterology, The Third Central Hospital of Tianjin, Tianjin, China., Guo X; Department of Hepatology, The Third People's Hospital of Taiyuan, Taiyuan, Shanxi, China., Feng Y; Department of Hepatology, The Third People's Hospital of Taiyuan, Taiyuan, Shanxi, China., Liu L; Department of Infectious Diseases, Lishui People's Hospital, Lishui, Zhejiang, China., Zhang X; Clinal Laboratory, Lishui People's Hospital, Lishui, Zhejiang, China., Qin W; Department of Gastroenterology, Baoding People's Hospital, Baoding, Heibei, China., Wang X; Department of Gastroenterology, Baoding People's Hospital, Baoding, Heibei, China., Rao W; Division of Hepatology, Liver Disease Center, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, China., Zhang Q; Division of Hepatology, Liver Disease Center, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, China., Tian Q; Division of Hepatology, Liver Disease Center, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, China., Zhang Y; Department of Infectious Diseases, Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China., Xie F; Department of Infectious Diseases, Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China., Jiang S; Department of Infectious Diseases, Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China., Yan Y; CHESS-COVID-19 Group, The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China., Qiu Y; CHESS-COVID-19 Group, The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China., Wu H; CHESS-COVID-19 Group, The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China., Hou Z; Department of Hepatobiliary Surgery, Jincheng People's Hospital, Jincheng, Shanxi, China., Zhang N; Department of Hepatobiliary Surgery, Jincheng People's Hospital, Jincheng, Shanxi, China., Zhang A; Department of Hepatobiliary Surgery, Jincheng People's Hospital, Jincheng, Shanxi, China., Ji J; CHESS-COVID-19 Group, Lishui Hospital of Zhejiang University, Lishui, Zhejiang, China., Yang J; CHESS-COVID-19 Group, Lishui Hospital of Zhejiang University, Lishui, Zhejiang, China., Huang J; CHESS-COVID-19 Group, Lishui Hospital of Zhejiang University, Lishui, Zhejiang, China., Zhao Z; CHESS-COVID-19 Group, Lishui Hospital of Zhejiang University, Lishui, Zhejiang, China., Gu Y; CHESS-COVID-19 Group, The Sixth People's Hospital of Shenyang, Shenyang, Liaoning, China., Bian L; CHESS-COVID-19 Group, The Sixth People's Hospital of Shenyang, Shenyang, Liaoning, China., Zhang Z; CHESS-COVID-19 Group, The Sixth People's Hospital of Shenyang, Shenyang, Liaoning, China., Zou S; Department of Hepatology, Zhenjiang Third Hospital Affiliated to Jiangsu University, Zhenjiang, Jiangsu, China., Ji H; Department of Hepatology, Zhenjiang Third Hospital Affiliated to Jiangsu University, Zhenjiang, Jiangsu, China., Ge G; Department of Hepatology, Zhenjiang Third Hospital Affiliated to Jiangsu University, Zhenjiang, Jiangsu, China., Du X; Department of Liver Diseases, The Third People's Hospital of Linfen City, Linfen, Shanxi, China., Hou A; Department of Liver Diseases, The Third People's Hospital of Linfen City, Linfen, Shanxi, China., Zhu Y; Department of Infectious Diseases, Liver Disease Center of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China., Cong Q; Department of Infectious Diseases, Liver Disease Center of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China., Xu J; Department of Infectious Diseases, Liver Disease Center of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China., Zu H; Department of Gastroenterology, The Fourth People's Hospital of Qinghai Province, Xining, Qinghai, China., Wang Y; Department of Gastroenterology, The Fourth People's Hospital of Qinghai Province, Xining, Qinghai, China., Yan Z; Department of Gastroenterology, The Fourth People's Hospital of Qinghai Province, Xining, Qinghai, China., Yan X; CHESS-COVID-19 Group, The Third People's Hospital of Tibet Autonomous Region, Lhasa, Tibet Autonomous Region, China., BianBa Y; CHESS-COVID-19 Group, The Third People's Hospital of Tibet Autonomous Region, Lhasa, Tibet Autonomous Region, China., Ci Q; CHESS-COVID-19 Group, The Third People's Hospital of Tibet Autonomous Region, Lhasa, Tibet Autonomous Region, China., Zhang L; Department of Infectious Diseases, The First Hospital of Lanzhou University, Lanzhou, Gansu, China., Yang S; Department of Infectious Diseases, The First Hospital of Lanzhou University, Lanzhou, Gansu, China., Gao X; Department of Infectious Diseases, The First Hospital of Lanzhou University, Lanzhou, Gansu, China., Zhong L; Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China., He S; Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China., Liu C; CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, Gansu, China., Huang Y; CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, Gansu, China., Liu Y; Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China., Xu D; CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, Gansu, China., Zhu Q; Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China., Xu X; Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China., Lv M; Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China., Zhang W; Department of Infectious Diseases, National Medical Center for Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, Shanghai, China. Electronic address: zhangwenhong@fudan.edu.cn., Qi X; CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, Gansu, China. Electronic address: qixiaolong@vip.163.com.
Jazyk:	angličtina
Zdroj:	Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [Clin Gastroenterol Hepatol] 2022 Jul; Vol. 20 (7), pp. 1516-1524.e2. Date of Electronic Publication: 2021 Dec 20.
DOI:	10.1016/j.cgh.2021.12.022
Abstrakt:	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. (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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