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

Wang, Jitao; Hou, Zhiyun; Liu, Jianxin; Gu, Ye; Wu, Yunhong; Chen, Zhenhuai; Ji, Jiansong; Diao, Shiqi; Qiu, Yuanwang; Zou, Shengqiang; Zhang, Aiguo; Zhang, Nina; Wang, Fengxian; Li, Xue; Wang, Yan; Liu, Xing; Lv, Cheng; Chen, Shubo; Liu, Dengxiang; Ji, Xiaolin; Liu, Chao; Ren, Tao; Sun, Jingwei; Zhao, Zhongwei; Wu, Fazong; Li, Fenxiang; Wang, Ruixu; Yan, Yan; Zhang, Shiliang; Ge, Guohong; Shao, Jiangbo; Yang, Shiying; Liu, Chuan; Huang, Yifei; Xu, Dan; Li, Xiaoguo; Ai, Jingwen; He, Qing; Zheng, Ming-Hua; Zhang, Liting; Xie, Qing; Rockey, Don C.; Fallowfield, Jonathan A.; Zhang, Wenhong; Qi, Xiaolong

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 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.