key: cord-0861658-5k13r06q authors: 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 title: Safety and immunogenicity of SARS-CoV-2 vaccines in patients with chronic liver diseases (CHESS-NMCID 2101): A multicenter study date: 2021-12-20 journal: Clin Gastroenterol Hepatol DOI: 10.1016/j.cgh.2021.12.022 sha: e1590012c50364b4433ac1037d26b38dc32cccef doc_id: 861658 cord_uid: 5k13r06q Background and aims We aim to assess the safety and immunogenicity of inactivated whole-virion 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 (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 one 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 non-cirrhotic CLD group, 78.9% in compensated cirrhotic group, 76.7% in decompensated cirrhotic group (P=0.894 among CLD subgroups) and 90.3% in healthy controls (P=0.008 versus CLD group). Conclusion Inactivated whole-virion SARS-CoV-2 vaccines are safe in patients with CLD. Patients with CLD had lower immunological response to SARS-CoV-2 vaccines than healthy population. The immunogenicity is similarly low in non-cirrhotic CLD, compensated cirrhosis and decompensated cirrhosis. Background and aims: We aim to assess the safety and immunogenicity of inactivated 120 whole-virion SARS-CoV-2 vaccines in patients with chronic liver diseases (CLD) in 121 this study. Written informed consents were obtained before the enrollment. The study 221 protocol and informed consent form were approved by the involved Ethics Committees. This study is registered at ClinicalTrials.gov, NCT04883177. The demographic characteristics of participants in CLD groups were shown in Table 1 , 269 and healthy control group in Supplementary Table 1 Table 2) . Overall, the most common 293 injection site adverse reaction was pain, which was reported in 36/437 (8.2%) cases. The most commonly reported systematic adverse reaction was fever, which was 295 reported in 9/437 (2.1%) cases. Additionally, among 164 patients with available (Table 3) . 323 Male gender was suggested to be an independent risk factor for negative serological In conclusion, inactivated whole-virion SARS-CoV-2 vaccines are safe in patients 398 with CLD, including patients with compensated and decompensated cirrhosis, 399 supporting current recommendations for patients with CLD. Our findings raise a 400 concern regarding lower immunological response to SARS-CoV-2 vaccines in patients 401 with CLD, and might help make recommendations of strengthening strategies in future.  Patients with non-cirrhotic CLD, compensated cirrhosis and decompensated cirrhosis, all have lower immunological response to SARS-CoV-2 vaccines than healthy population.  The data in this study supported current recommendations for people with CLD to get SARS-CoV-2 vaccination.  In future, patients with CLD might need strengthening strategies, such as a boosting dose of SARS-CoV-2 vaccination, to get better response. WHO Coronavirus (COVID-19) Dashboard Available The first 12 months of COVID-19: a timeline of 415 immunological insights Global burden of NAFLD and NASH: trends, predictions, 417 risk factors and prevention Burden of liver diseases in the world hepatitis topics Available Changes in the Global Burden of Chronic Liver Diseases 422 From 2012 to 2017: The Growing Impact of NAFLD Outcomes following SARS-CoV-2 infection in patients with 424 chronic liver disease: An international registry study Pre-existing liver disease is associated with poor outcome 426 in patients with SARS CoV2 infection High rates of 30-day mortality in patients with cirrhosis 429 and COVID-19 Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine a randomised, double-blind CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 435 1/2 clinical trial Safety and immunogenicity of ChAdOx1 nCoV-437 19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, 438 randomised, controlled, phase 2/3 trial Safety and Immunogenicity of Two RNA-Based 440 Covid-19 Vaccine Candidates Safety, tolerability, and immunogenicity of a recombinant 442 adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-443 human trial Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients Low immunogenicity to SARS-CoV-2 vaccination 449 among liver transplant recipients Safety and immunogenicity of COVID-19 vaccination in patients with 451 non-alcoholic fatty liver disease (CHESS2101): A multicenter study Analysis of antibody responses after COVID-19 vaccination 453 in liver transplant recipients and those with chronic liver diseases Vaccination (First version) AST (U/L) Data are displayed as median (interquartile range) and n (%). CLD=Chronic liver diseases, BMI= Body mass index, NAFLD=Nonalcoholic fatty liver disease, 500ALD=Alcoholic liver disease, AIH=Autoimmune hepatitis, PBC=Primary biliary cholangitis, PSC=Primary sclerosing cholangitis, ALT=Alanine 501 aminotransferase, AST=Aspartate aminotransferase, GGT=γ-glutamyl transpeptidase, AKP=Alkaline phosphatase, TBIL=Total bilirubin, DBIL=Direct 502 bilirubin, ALB=Albumin, HTN= Hypertension, DM= Diabetes mellitus, CAD=Coronary artery disease, Arrhy=Arrhythmia. 503