tetano
Editor, Senior Moderator
Hepatol Int
. 2022 Apr 9.
doi: 10.1007/s12072-022-10332-9. Online ahead of print.
Safety and immunogenicity of SARS-CoV-2 vaccines in Chinese patients with cirrhosis: a prospective multicenter study
Jitao Wang[SUP] #[/SUP][SUP] 1 2 [/SUP], Qiran Zhang[SUP] #[/SUP][SUP] 3 [/SUP], Jingwen Ai[SUP] #[/SUP][SUP] 3 [/SUP], Dengxiang Liu[SUP] #[/SUP][SUP] 2 [/SUP], Chuan Liu[SUP] #[/SUP][SUP] 1 [/SUP], Huiling Xiang[SUP] #[/SUP][SUP] 4 [/SUP], Ye Gu[SUP] #[/SUP][SUP] 5 [/SUP], Ying Guo[SUP] 6 [/SUP], Jiaojian Lv[SUP] 7 [/SUP], Yifei Huang[SUP] 1 [/SUP], Yanna Liu[SUP] 8 [/SUP], Dan Xu[SUP] 1 [/SUP], Shubo Chen[SUP] 2 [/SUP], Jinlong Li[SUP] 2 [/SUP], Qianqian Li[SUP] 4 [/SUP], Jing Liang[SUP] 4 [/SUP], Li Bian[SUP] 5 [/SUP], Zhen Zhang[SUP] 5 [/SUP], Xiaoqing Guo[SUP] 6 [/SUP], Yinong Feng[SUP] 6 [/SUP], Luxiang Liu[SUP] 7 [/SUP], Xuying Zhang[SUP] 9 [/SUP], Yanliang Zhang[SUP] 10 [/SUP], Faren Xie[SUP] 10 [/SUP], Shujun Jiang[SUP] 10 [/SUP], Wei Qin[SUP] 11 [/SUP], Xiaodong Wang[SUP] 11 [/SUP], Wei Rao[SUP] 12 [/SUP], Qun Zhang[SUP] 12 [/SUP], Qiuju Tian[SUP] 12 [/SUP], Ying Zhu[SUP] 13 [/SUP], Qingwei Cong[SUP] 13 [/SUP], Juan Xu[SUP] 13 [/SUP], Zhiyun Hou[SUP] 14 [/SUP], Nina Zhang[SUP] 14 [/SUP], Aiguo Zhang[SUP] 14 [/SUP], Hongmei Zu[SUP] 15 [/SUP], Yun Wang[SUP] 15 [/SUP], Zhaolan Yan[SUP] 15 [/SUP], Xiufang Du[SUP] 16 [/SUP], Aifang Hou[SUP] 16 [/SUP], Yan Yan[SUP] 17 [/SUP], Yuanwang Qiu[SUP] 17 [/SUP], Hangyuan Wu[SUP] 17 [/SUP], Shengjuan Hu[SUP] 18 [/SUP], Yanhong Deng[SUP] 18 [/SUP], Jiansong Ji[SUP] 19 [/SUP], Jie Yang[SUP] 19 [/SUP], Jiansheng Huang[SUP] 19 [/SUP], Zhongwei Zhao[SUP] 19 [/SUP], Shengqiang Zou[SUP] 20 [/SUP], Hailei Ji[SUP] 20 [/SUP], Guohong Ge[SUP] 20 [/SUP], Li Zhong[SUP] 21 [/SUP], Song He[SUP] 21 [/SUP], Xiaosong Yan[SUP] 22 [/SUP], Bian Ba Yangzhen[SUP] 22 [/SUP], Ci Qu[SUP] 22 [/SUP], Liting Zhang[SUP] 23 [/SUP], Shiying Yang[SUP] 23 [/SUP], Xiaoqin Gao[SUP] 23 [/SUP], Muhan Lv[SUP] 24 [/SUP], Qingliang Zhu[SUP] 24 [/SUP], Xinxin Xu[SUP] 24 [/SUP], Qing-Lei Zeng[SUP] 25 [/SUP], Xiaolong Qi[SUP] 26 [/SUP], Wenhong Zhang[SUP] 27 [/SUP]
Affiliations
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.
Keywords: Child–Pugh; Compensated cirrhosis; Coronavirus disease 2019; Decompensated cirrhosis; Hepatitis B virus; Immunogenicity; Safety; Severe acute respiratory syndrome coronavirus 2; Vaccination; Vaccine.
. 2022 Apr 9.
doi: 10.1007/s12072-022-10332-9. Online ahead of print.
Safety and immunogenicity of SARS-CoV-2 vaccines in Chinese patients with cirrhosis: a prospective multicenter study
Jitao Wang[SUP] #[/SUP][SUP] 1 2 [/SUP], Qiran Zhang[SUP] #[/SUP][SUP] 3 [/SUP], Jingwen Ai[SUP] #[/SUP][SUP] 3 [/SUP], Dengxiang Liu[SUP] #[/SUP][SUP] 2 [/SUP], Chuan Liu[SUP] #[/SUP][SUP] 1 [/SUP], Huiling Xiang[SUP] #[/SUP][SUP] 4 [/SUP], Ye Gu[SUP] #[/SUP][SUP] 5 [/SUP], Ying Guo[SUP] 6 [/SUP], Jiaojian Lv[SUP] 7 [/SUP], Yifei Huang[SUP] 1 [/SUP], Yanna Liu[SUP] 8 [/SUP], Dan Xu[SUP] 1 [/SUP], Shubo Chen[SUP] 2 [/SUP], Jinlong Li[SUP] 2 [/SUP], Qianqian Li[SUP] 4 [/SUP], Jing Liang[SUP] 4 [/SUP], Li Bian[SUP] 5 [/SUP], Zhen Zhang[SUP] 5 [/SUP], Xiaoqing Guo[SUP] 6 [/SUP], Yinong Feng[SUP] 6 [/SUP], Luxiang Liu[SUP] 7 [/SUP], Xuying Zhang[SUP] 9 [/SUP], Yanliang Zhang[SUP] 10 [/SUP], Faren Xie[SUP] 10 [/SUP], Shujun Jiang[SUP] 10 [/SUP], Wei Qin[SUP] 11 [/SUP], Xiaodong Wang[SUP] 11 [/SUP], Wei Rao[SUP] 12 [/SUP], Qun Zhang[SUP] 12 [/SUP], Qiuju Tian[SUP] 12 [/SUP], Ying Zhu[SUP] 13 [/SUP], Qingwei Cong[SUP] 13 [/SUP], Juan Xu[SUP] 13 [/SUP], Zhiyun Hou[SUP] 14 [/SUP], Nina Zhang[SUP] 14 [/SUP], Aiguo Zhang[SUP] 14 [/SUP], Hongmei Zu[SUP] 15 [/SUP], Yun Wang[SUP] 15 [/SUP], Zhaolan Yan[SUP] 15 [/SUP], Xiufang Du[SUP] 16 [/SUP], Aifang Hou[SUP] 16 [/SUP], Yan Yan[SUP] 17 [/SUP], Yuanwang Qiu[SUP] 17 [/SUP], Hangyuan Wu[SUP] 17 [/SUP], Shengjuan Hu[SUP] 18 [/SUP], Yanhong Deng[SUP] 18 [/SUP], Jiansong Ji[SUP] 19 [/SUP], Jie Yang[SUP] 19 [/SUP], Jiansheng Huang[SUP] 19 [/SUP], Zhongwei Zhao[SUP] 19 [/SUP], Shengqiang Zou[SUP] 20 [/SUP], Hailei Ji[SUP] 20 [/SUP], Guohong Ge[SUP] 20 [/SUP], Li Zhong[SUP] 21 [/SUP], Song He[SUP] 21 [/SUP], Xiaosong Yan[SUP] 22 [/SUP], Bian Ba Yangzhen[SUP] 22 [/SUP], Ci Qu[SUP] 22 [/SUP], Liting Zhang[SUP] 23 [/SUP], Shiying Yang[SUP] 23 [/SUP], Xiaoqin Gao[SUP] 23 [/SUP], Muhan Lv[SUP] 24 [/SUP], Qingliang Zhu[SUP] 24 [/SUP], Xinxin Xu[SUP] 24 [/SUP], Qing-Lei Zeng[SUP] 25 [/SUP], Xiaolong Qi[SUP] 26 [/SUP], Wenhong Zhang[SUP] 27 [/SUP]
Affiliations
- PMID: 35403977
- DOI: 10.1007/s12072-022-10332-9
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.
Keywords: Child–Pugh; Compensated cirrhosis; Coronavirus disease 2019; Decompensated cirrhosis; Hepatitis B virus; Immunogenicity; Safety; Severe acute respiratory syndrome coronavirus 2; Vaccination; Vaccine.