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Science China(Life Sciences) 2016年第11期59卷 1198-1201页

作者： Qinjian Zhao Ningshao Xia state key laboratory of molecular vaccinology and molecular diagnostics School of Public Health Xiamen University national institute of diagnostics and vaccine development in infectious diseases School of Life Sciences Xiamen University

The 2016 Lasker-DeBakey Clinical Medical Research Award was given to three scientists working on different stages of the translational sciences on bringing a high efficacious therapy against hepatitis C virus(HCV)infe... 详细信息

关键词： HCV Innovative hepatitis C virus replicons leading to drug development for hepatitis C cure The 2016 Lasker-DeBakey Clinical Medical Research Award

Replication, pathogenicity, and transmission of SARS-CoV-2 in minks

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national Science Review 2021年第3期8卷 21-28页

作者： Lei Shuai Gongxun Zhong Quan Yuan Zhiyuan Wen Chong Wang Xijun He Renqiang Liu Jinliang Wang Qinjian Zhao Yuxiu Liu Ningning Huo Junhua Deng Jingjing Bai Hongchao Wu Yuntao Guan Jianzhong Shi Kegong Tian Ningshao Xia Hualan Chen Zhigao Bu state key laboratory of Veterinary Biotechnology Harbin Veterinary Research Institute Chinese Academy of Agricultural Sciences national High Containment laboratory for Animal diseases Control and Prevention state key laboratory of molecular vaccinology and molecular diagnostics National Institute of Diagnostics and Vaccine Development in Infectious DiseasesSchool of Public Health Xiamen University national Research Center for Veterinary Medicine

Minks are raised in many countries and have transmitted severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) to ***,the biologic properties of SARS-CoV-2 in minks are largely ***,we investigated and found that SARS-CoV-2 replicates efficiently in both the upper and lower respiratory tracts,and transmits efficiently in minks via respiratory droplets;pulmonary lesions caused by SARS-CoV-2 in minks are similar to those seen in humans with *** further found that a spike protein-based subunit vaccine largely prevented SARS-CoV-2 replication and lung damage caused by SARS-CoV-2 infection in *** study indicates that minks are a useful animal model for evaluating the efficacy of drugs or vaccines against COVID-19 and that vaccination is a potential strategy to prevent minks from transmitting SARS-CoV-2.

关键词： SARS-CoV-2 mink replication pathogenicity transmission animal model

Progress in immunotherapy

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Science China(Life Sciences) 2023年第4期66卷 653-657页

作者： Bing Sun Ningshao Xia Xuan Zhang state key laboratory of Cell Biology Shanghai Institute of Biochemistry and Cell BiologyCenter for Excellence in Molecular Cell ScienceChinese Academy of SciencesUniversity of Chinese Academy of SciencesShanghai 200031China School of Life Science and Technology ShanghaiTech UniversityShanghai 201210China state key laboratory of molecular vaccinology and molecular diagnostics National Institute of Diagnostics and Vaccine Development in Infectious DiseasesSchool of Life Sciences&School of Public HealthXiamen UniversityXiamen 361102China Xiang An Biomedicine laboratory Xiamen 361102China Research Unit of Frontier Technology of Structural vaccinology Chinese Academy of Medical SciencesXiamen 361102China Department of Rheumatology Beijing HospitalNational Center of GerontologyInstitute of Geriatric MedicineClinical Immunology CenterChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100730China

Immunotherapy employs the immune system to combat diseases including cancer,autoimmune diseases,infectious diseases and degenerative diseases,for both treatment and prevention of the *** application of immunotherapies has a long history,with the milestone of identifying cow pox as the smallpox vaccine more than 200 years ago as an example(Cook,1996).After that,in 1890,Emil Behring and Kitasato Shibasaburōpublished the first paper on serum therapy which ushered an era of antibody *** progress on basic research of immunological principles and the boost of bioengineering facilitates the fast evolution of immunotherapy in recent *** has changed the landscape of healthcare and promoted some advanced concepts to control diseases in *** this issue,we selected the major topics on immunotherapy including antibody therapy,vaccine,and immune cell therapy for summarizing current progress in this field.

关键词： immunotherapy vaccine prevention

基于大肠杆菌表达的重组九价人乳头瘤病毒(HPV 6/11/16/18/31/33/45/52/58型)疫苗免疫原性和安全性的Ⅱ期临床试验

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Science Bulletin 2023年第20期68卷 2448-2455,M0006页

作者：胡月梅毕兆峰郑亚张黎郑凤珠储凯李亚飞陈祺全佳丽胡潇文黄兴成朱孔鑫王江雅慧姜汉民臧霞刘东林杨昌林潘红星张秋芬苏迎盈黄守杰孙光黄维金黄悦吴婷张军夏宁邵 Jiangsu Provincial Center for disease Control and Prevention Public Health Research Institute of Jiangsu ProvinceNanjing 210009China state key laboratory of vaccines for infectious diseases Xiang An Biomedicine LaboratorySchool of Public HealthXiamen UniversityXiamen 361102China national institute of diagnostics and vaccine development in infectious diseases State Key Laboratory of Molecular Vaccinology and Molecular DiagnosticsNational Innovation Platform for Industry-Education Integration in Vaccine ResearchNMPA Key Laboratory for Research and Evaluation of Infectious Disease Diagnostic TechnologyXiamen UniversityXiamen 361102China national institutes for Food and Drug Control Beijing 102629China Xiamen Innovax Biotech Company Xiamen 361027China Dongtai Center for disease Control and Prevention Yancheng 224200China

人乳头瘤病毒(HPV)16/18型双价疫苗(大肠埃希菌)已上市并通过世界卫生组织预认证.本研究通过一项随机双盲Ⅱ期临床试验评估其第二代HPV6/11/16/18/31/33/45/52/58型九价疫苗在18~45岁健康女性中的免疫原性和安全性.来自江苏省东台市的62... 详细信息

人乳头瘤病毒(HPV)16/18型双价疫苗(大肠埃希菌)已上市并通过世界卫生组织预认证.本研究通过一项随机双盲Ⅱ期临床试验评估其第二代HPV6/11/16/18/31/33/45/52/58型九价疫苗在18~45岁健康女性中的免疫原性和安全性.来自江苏省东台市的627名女性志愿者1:1随机分配至九价疫苗组(313人)或对照组(314人),并按照0、1、6月接种程序分别接种三剂1.0 mL(270μg)九价疫苗或空白佐剂,主要终点为第7月时血清抗体阳转率和抗体水平.结果显示,几乎所有疫苗组符合方案人群在第7月时出现针对9种HPV型别的血清中和抗体阳转,仅2人未发生HPV11型阳转,1人未发生HPV52型阳转.九价疫苗组和对照组的总体不良事件发生率分别为80.8%和72.9%,绝大多数不良事件症状轻微并很快恢复,未发生疫苗相关严重不良事件.该研究证明候选九价疫苗具有良好的安全性和免疫原性,支持在更大人群中进一步进行效力研究.

关键词： Ⅱ期临床试验免疫原性人乳头瘤病毒江苏省东台市双价疫苗大肠杆菌表达随机分配大肠埃希菌

Dexamethasone ameliorates severe pneumonia but slightly enhances viral replication in the lungs of SARS-CoV-2-infected Syrian hamsters

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Cellular & molecular Immunology 2022年第2期19卷 290-292页

作者： Lunzhi Yuan Ming Zhou Jian Ma Xuan Liu Peiwen Chen Huachen Zhu Qiyi Tang Tong Cheng Yi Guan Ningshao Xia state key laboratory of molecular vaccinology and molecular diagnostics National Institute of Diagnostics and Vaccine Development in Infectious DiseasesSchool of Life SciencesSchool of Public HealthXiamen UniversityXiamenFujianChina. state key laboratory of Emerging infectious diseases School of Public HealthLi Ka Shing Faculty of MedicineThe University of Hong KongHong KongSARChina. Guangdong-Hong Kong Joint laboratory of Emerging infectious diseases/Joint laboratory for International Collaboration in Virology and Emerging infectious diseases Joint Institute of Virology(STU/HKU)Shantou UniversityShantouGuangdongChina. EKIH Pathogen Research institute Futian DistrictShenzhenGuangdongChina. Department of Microbiology Howard University College of MedicineWashingtonDCUSA. Research Unit of Frontier Technology of Structural vaccinology Chinese Academy of Medical SciencesXiamenFujianChina.

The pandemic caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)has resulted in more than 230 million cases and over four million deaths ***,multiple emerging SARS-CoV-2 variants have shown enhanced infectivity,transmissibility,pathogenicity and ability to escape neutralization by vaccine-induced humoral immunity[1].The antibody resistance of SARS-CoV-2 variants constitutes a challenge for current vaccines and therapeutic *** specific antiviral is currently available for coronavirus in humans[2].Although remdesivir was approved by the FDA for the treatment of SARS-CoV-2 infection,the therapeutic effect is limited,particularly for critical cases with severe pneumonia.

关键词： immunity pneumonia vaccine

氮杂胞苷靶向SARS-CoV-2病毒RNA作为治疗COVID-19的潜在药物

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Science Bulletin 2022年第10期67卷 1022-1025,M0003页

作者：林显柯贤良蹇晓沁夏琳杨洋张田英熊华龙赵冰海刘文陈全姣唐冲 CAS key laboratory of Special Pathogens and Biosafety Wuhan Institute of VirologyChinese Academy of SciencesWuhan 430071China Fujian Provincial key laboratory of Innovative Drug Target Research School of Pharmaceutical SciencesXiamen UniversityXiamen 361102China Shenzhen key laboratory of Pathogen and Immunity National Clinical Research Center for Infectious DiseaseState Key Discipline of Infectious DiseaseShenzhen Third People’s HospitalShenzhen 518020China state key laboratory of molecular vaccinology and molecular diagnostics National Institute of Diagnostics and Vaccine Development in Infectious DiseasesSchool of Public HealthXiamen UniversityXiamen 361102China Department of Pathophysiology School of MedicineBeihua UniversityJilin 132011China

报道了一种美国食品药品监督管理局批准用于治疗骨髓发育异常综合征的药物:氮杂胞苷(Azacytidine),其具有显著的体外抑制新型冠状病毒增殖的能力.小鼠体内实验表明,氮杂胞苷能够显著改善新型冠状病毒感染引起的肺部损伤,提升小鼠在病毒... 详细信息

报道了一种美国食品药品监督管理局批准用于治疗骨髓发育异常综合征的药物:氮杂胞苷(Azacytidine),其具有显著的体外抑制新型冠状病毒增殖的能力.小鼠体内实验表明,氮杂胞苷能够显著改善新型冠状病毒感染引起的肺部损伤,提升小鼠在病毒感染后的存活率.进一步的研究发现,氮杂胞苷能够整合到病毒基因组RNA中.氮杂胞苷是胞苷类似物,能够通过与RNA甲基转移酶结合而抑制RNA中m^(5)C的甲基化,因此,氮杂胞苷可能抑制新型冠状病毒基因组RNA的m^(5)C甲基化修饰.本研究证明了新型冠状病毒基因组RNA能够发生m^(5)C甲基化修饰,并且氮杂胞苷可能通过影响新冠病毒基因组m^(5)C修饰的方式抑制病毒的增殖,提示氮杂胞苷具有潜在治疗新型冠状病毒肺炎(COVID-19)的作用.

关键词：美国食品药品监督管理局氮杂胞苷新型冠状病毒病毒基因组病毒RNA 冠状病毒感染体内实验甲基转移酶

molecular and functional analysis of monoclonal antibodies in support of biologics development

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Protein & Cell 2018年第1期9卷 74-85页

作者： Xin Wang Zhiqiang An Wenxin Luo Ningshao Xia Qinjian Zhao state key laboratory of molecular vaccinology and molecular diagnostics National Institute of Diagnostics and Vaccine Development in Infectious Diseases School of Public Health Xiamen University Xiamen 361105 China School of Life Sciences Xiamen University Xiamen 361105 China Texas Therapeutics institute The Brown Foundation Institute of Molecular Medicine The University of Texas Health Science Center at Houston Houston TX 77054 USA

Monoclonal antibody （mAb）-based therapeutics are playing an increasingly important role in the treatment or pre- vention of many important diseases such as cancers, autoimmune disorders, and infectious diseases. Multi- domain mAbs are far more complex than small molecule drugs with intrinsic heterogeneities. The critical quality attributes of a given mAb, including structure, post-trans- lational modifications, and functions at biomolecular and cellular levels, need to be defined and profiled in details during the developmental phases of a biologics. These critical quality attributes, outlined in this review, serve an important database for defining the drug properties during commercial production phase as well as post licensure life cycle managemenL Specially, the molecular characteriza- tion, functional assessment, and effector function analysis of mAbs, are reviewed with respect to the critical parame- ters and the methods used for obtaining them. The three groups of analytical methods are three essential and inte. gral facets making up the whole analytical package for a mAIPbased drug. Such a package is critically important for the licensure and the post-licensurs life cycle management of a therapeutic or prophylactic biologics. In addition, the basic principles on the evaluation of biosimilar mAbs were discussed briefly based on the recommendations by the World Health Organization.

关键词： monoclonal antibody molecularchar acterization ligand binding assay cell based assay,heterogeneity functional assessment

Liver chimeric mice with tupaia hepatocyte transplantation as an animal model for hepatitis B virus infection and antiviral therapy

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Biosafety and Health 2019年第2期1卷 76-83页

作者： Lunzhi Yuan Yao Chen Xuan Liu Yali Zhang Ming Zhou Kun Wu Quan Yuan Tong Cheng Ningshao Xia state key laboratory of molecular vaccinology and molecular diagnostics School of Public HealthXiamen UniversityXiamen 361102China national institute of diagnostics and vaccine development in infectious diseases School of Life SciencesXiamen UniversityXiamen 361102China

The human liver chimeric mouse is a milestone animal model for hepatitis B virus(HBV)*** mice with primary human hepatocyte(PHH)transplantation are adequate to support chronic HBV infection for several weeks and to evaluate antiviral ***,the drawbacks of PHHs include lack of available donors,poor expansion in vitro and ethical issues that limit the application of human liver chimeric mice,necessitating the search for ***,we transplanted primary tupaia hepatocytes(PTHs)into the livers of immunodeficient mice and achieved high liver chimerism within six *** tupaia liver chimeric mice are adequate to support chronic infection of the four common HBV genotypes A,B,C and D for 36 weeks,as well as evaluate of antiviral drugs,including hepatitis B immune globulin(HBIG),monoclonal antibody and nucleoside analogues(NAs),for preventative therapy and treatment post *** conclusion,the tupaia liver chimeric mouse model provides a convenient,efficient and stable animal model for chronic HBV infection and long-term drug evaluation.

关键词： Tupaia Hepatitis B Liver chimeric mice infectious animal model Antiviral therapy

Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs.3 doses in young women

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Science China(Life Sciences) 2020年第4期63卷 582-591页

作者： Yue-Mei Hu Meng Guo Chang-Gui Li Kai Chu Wen-Gang He Jing Zhang Jian-Xiang Gu Juan Li Hui Zhao Xiang-Hong Wu Bi-Zhen Lin Zhi-Jie Lin Xing-Mei Yao Ya-Fei Li Fei-Xue Wei Yue Huang Ying-Ying Su Feng-Cai Zhu Shou-Jie Huang Hui-Rong Pan Ting Wu Jun Zhang Ning-Shao Xia Jiangsu Provincial Center for disease Control and Prevention Nanjing 210009China The state key laboratory of molecular vaccinology and molecular diagnostics National Institute of Diagnostics and Vaccine Development in Infectious DiseasesCollaborative Innovation Center of Biologic ProductsSchool of Public HealthXiamen UniversityXiamen 361102China national institute for Food and Drug Control Beijing 102629China Sheyang Center for disease Control and Prevention Sheyang 244300China Xiamen Innovax Biotech Company Xiamen 361022China

A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women.A randomized,immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in *** aged 9–14 years were randomized to receive 2 doses at months 0 and 6(n=301)or 3 doses at months 0,1 and 6(n=304).Girls aged 15–17 years(n=149)and women aged 18–26 years(n=225)received 3 *** objectives included noninferiority analysis of the IgG geometric mean concentration(GMC)ratio(95%CI,lower bound>0.5)to HPV-16 and HPV-18 at month 7 in girls compared with *** the per-protocol set,the GMC ratio of IgG was noninferior for girls aged 9–17 years receiving 3 doses compared with women(1.76(95%CI,1.56,1.99)for HPV-16 and 1.93(95%CI,1.69,2.21)for HPV-18)and noninferior for girls aged 9–14 years receiving 2 doses compared with women(1.45(95%CI,1.25,1.62)for HPV-16 and 1.17(95%CI,1.02,1.33)for HPV-18).Noninferiority was also demonstrated for neutralizing *** immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.

关键词： immunobridging noninferiority human papillomavirus vaccine Escherichia coli girls

Contact pattern,current immune barrier,and pathogen virulence determines the optimal strategy of further vaccination

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infectious disease Modelling 2023年第1期8卷 192-202页

作者： Xiaohao Guo Ziyan Liu Shiting Yang Zeyu Zhao Yichao Guo Guzainuer Abudurusuli Shanlu Zhao Ge Zeng Shixiong Hu Kaiwei Luo Tianmu Chen state key laboratory of molecular vaccinology and molecular diagnostics School of Public HealthXiamen UniversityXiamen City361102Fujian ProvincePeople's Republic of China Hunan Provincial Center for disease Control and Prevention 405 Furong Middle Road Section OneKaifu DistrictChangsha City410001Hunan ProvincePeople's Republic of China

Background:The current outbreak of novel coronavirus disease 2019 has caused a seriousdisease burden *** are an important factor to sustain the *** with a relatively high-vaccination worldwide,the decay of vaccine efficacy andthe arising of new variants lead us to the challenge of maintaining a sufficient immunebarrier to protect the ***:A case-contact tracking data in Hunan,China,is used to estimate the contactpattern of cases for scenarios including school,workspace,etc,rather than ordinary susceptible *** on the estimated vaccine coverage and efficacy,a multi-groupvaccinated-exposed-presymptomatic-symptomatic-asymptomatic-removed model(VEFIAR)with 8 age groups,with each partitioned into 4 vaccination status groups *** optimal dose-wise vaccinating strategy is optimized based on the currentlyestimated immunity barrier of coverage and efficacy,using the greedy algorithm thatminimizes the cumulative cases,population size of hospitalization and fatality respectivelyin a certain future *** of Delta and Omicron variants are used respectivelyin the ***:The estimated contact matrices of cases showed a concentration on middle ages,and has compatible magnitudes compared to estimations from contact surveys in *** VEFIAR model is numerically *** optimal controled vaccination strategy requires immediate vaccination on the un-vaccinated high-contact population of age30e39 to reduce the cumulative cases,and is stable with different basic reproductionnumbers(R_(0)).As for minimizing hospitalization and fatality,the optimized strategy requires vaccination on the un-vaccinated of both aged 30e39 of high contact frequencyand the vulnerable ***:The objective of reducing transmission requires vaccination in age groups ofthe highest contact frequency,with more priority for un-vaccinated than un-fully or *** objective of reducing total ho

关键词： vaccine Allocation strategy SARS-CoV-2 Optimal control Immune barrier Contact pattern Greedy algorithm