Chinese chess study: novel coronavirus vaccine is safe and effective for nonalcoholic fatty liver disease

In April 2021, the international authoritative journal of Hepatology (top, sciif: 20.582) published the latest multi center study of China’s chess 2101 online, which proved the safety and effectiveness of novel coronavirus vaccine for non-alcoholic fatty liver disease for the first time

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This study was jointly initiated by Qi Xiaolong, head of chess and assistant president of the first hospital of Lanzhou University, and Zhang Wenhong, director of Department of infection, Huashan Hospital Affiliated to Fudan University

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Great progress has been made in the development and application of novel coronavirus vaccine, and a number of clinical trials have proved its good safety and effectiveness

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Although a large number of clinical studies have been carried out, only a small number of patients with liver diseases have been included

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Due to the lack of research data on new coronal vaccine for people with liver diseases, EASL and AASLD issued consensus opinions to recommend new coronal vaccine for people with liver diseases (Cornberg m, et al; FixOK,etal.Hepatology2021)。 Nonalcoholic fatty liver disease (NAFLD) has become one of the main causes of chronic liver disease in developed countries and China

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Previous studies have confirmed novel coronavirus pneumonia is a susceptible population of NAFLD patients, and is associated with the progression of novel coronavirus pneumonia (JiD, etal.JHepatol2020)

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MeijnikmanAS,etal.JHepatol2021)。 Novel coronavirus pneumonia history in 11 cooperative hospitals was retrospectively reviewed from October 4, 2020 to February 2021 in 26 CHESS2101, and the follow-up period was March 18, 2021

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The NAFLD population was reviewed in a multicenter study

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All participants have completed two doses of Xinguan inactivated vaccine (Beijing Institute of biological products)

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Blood samples were collected at least 14 days after vaccination, and the neutralizing antibodies were detected by the new coronavirus neutralizing antibody assay kit (Beijing rejing Biology) based on magnetic particle chemiluminescence immunoassay

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The main safety end point was the incidence of adverse reactions within 7 days and 28 days after each novel coronavirus vaccine injection

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The main immunogenicity end point was the neutralizing antibody response rate at least 14 days after the whole vaccination

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A total of 381 subjects with NAFLD were included in this study

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The median age was 39.0 years, 179 males (47.0%) and the median body mass index was 26.1kg/m ²、 348 cases (91.3%) were Han nationality

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There were 53 cases of previous complications (13.9%), including 42 cases of hypertension (11.0%), 14 cases of diabetes (3.7%), 4 cases of arrhythmia (1.0%) and 1 case of asthma (0.3%)

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The results showed that 95 cases (24.9%) and 112 cases (29.4%) had adverse reactions within 7 days and 28 days after each injection, respectively

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The most common adverse reactions were injection site pain in 70 cases (18.4%), followed by muscle pain in 21 cases (5.5%), headache in 20 cases (5.2%) and fatigue in 18 cases (4.7%)

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The above adverse reactions were mild self limiting reactions, and no grade 3 adverse reactions were observed

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The median interval from the completion of the whole immunization to neutralizing antibody detection was 39.0 days (interquartile range 35.0-50.0 days)

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Among them, 364 (95.5%) patients with NAFLD were detected NCV neutralizing antibody

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Previously, although the results of phase III clinical trials of a variety of novel coronavirus vaccines have been published, the sample size of patients with previous chronic liver disease is limited (polackfp, et al; BadenLR,etal.NEnglJMed2021)。 This study confirmed that the side effects of NAFLD population after vaccination with Chinese novel coronavirus vaccine were mild and self limited, and no serious adverse events were observed

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Compared with the phase II clinical trial using the same vaccine in this study (Xiaos, et al

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Jama2020), the positive rate of neutralizing antibody in NAFLD population is similar to that in general population

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However, this study has the following limitations: firstly, the retrospective study lacks the histopathological grading / staging of NAFLD, and the baseline liver function and neutralizing antibody information before the injection of novel coronavirus vaccine

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Second, whether neutralizing antibodies produced by vaccination can protect NAFLD population from NCV infection remains unclear

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Therefore, a larger prospective cohort study is needed to further evaluate the efficacy of neutralizing antibodies in NAFLD population (i.e., the protection against severe diseases and adverse outcomes)

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Novel coronavirus pneumonia (CHESS assistant director, assistant dean of First Hospital Affiliated to Lanzhou University), Zhang Wenhong (director of infectious diseases division, head of clinical treatment expert group of Shanghai anti novel coronavirus pneumonia), was co author of this study by CHESS researcher

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Wang Jitao (Xingtai people’s Hospital), Hou Zhiyun (Jincheng people’s Hospital), Liu Jianxin (Jinzhou Central Hospital), Gu Ye (Shenyang Sixth People’s Hospital), Wu Yunhong (Tibet Chengban hospital), Chen Zhenhuai (Baoding people’s Hospital), Ji Jiansong (Lishui Central Hospital) and Diao Shiqi (Linfen Third People’s Hospital) served as co first authors

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Qiu Yuanwang (the Fifth People’s Hospital of Wuxi City), Zou Shengqiang (the third people’s Hospital of Zhenjiang City), Zhang Liting (the first hospital of Lanzhou University), etc..

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