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

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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） infection to a reality. An effective treatment of HCV chronic infection was developed, by a team led by Michael Sofia, using a prodrug approach and the drug PSI-7977 or Sofosbuvir was approved in 2013 less than 28 years after the initial discovery of HCV.

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

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

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基于红细胞的疫苗载体研究进展

临床输血与检验 2024年第3期26卷 404-411页

作者：甘丽易平赵勤俭张馨元四川大学华西口腔医院四川成都610041 重庆医科大学药学院重庆400016

红细胞在机体内含量丰富,主要功能是运输氧气。成熟哺乳动物红细胞无细胞核和细胞器,且比表面积大、易于修饰,是理想的递送载体,已被广泛用于药物递送。红细胞还具有免疫调节功能。红细胞能够结合循环中的病原体并与趋化因子相互作用参... 详细信息

红细胞在机体内含量丰富,主要功能是运输氧气。成熟哺乳动物红细胞无细胞核和细胞器,且比表面积大、易于修饰,是理想的递送载体,已被广泛用于药物递送。红细胞还具有免疫调节功能。红细胞能够结合循环中的病原体并与趋化因子相互作用参与固有免疫应答。衰老的红细胞通过调节膜表面分子的表达,与脾脏中的吞噬细胞相互作用,从而调节适应性免疫应答,使衰老红细胞最终以非炎症途径被清除。基于红细胞在递送和免疫调节方面的优势,红细胞载体开始用于新型疫苗中传统疫苗佐剂的替代。基于红细胞载体的合成方法多样,生物安全性良好且易于修饰,能够满足不同疫苗的需求。处于不同阶段的红细胞载体通过设计能够发挥不同的免疫调节功能。基于正常红细胞的载体能够诱导免疫激活,而基于衰老红细胞的载体可用于诱导免疫耐受,在肿瘤、传染病、自身免疫性疾病的预防和治疗中均有良好效果。本文从红细胞作为疫苗载体的生物学优势、基于红细胞的疫苗载体与抗原的作用形式及其免疫效果、红细胞载体的优化策略等方面进行综述,为新型疫苗的研发提供方向。

关键词：疫苗红细胞递送载体免疫激活免疫耐受

Capsid destabilization and epitope alterations of human papillomavirus 18 in the presence of thimerosal

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Journal of Pharmaceutical Analysis 2021年第5期11卷 617-627页

作者： Xiaofen Huang Yike Li Meifeng Nie Mingxi Yue Yufang Li Zhijie Lin Huirong Pan Mujin Fang Ting Wu Shaowei Li Jun Zhang Ningshao Xia qinjian zhao State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics National Institute of Diagnostics and Vaccine Development in Infectious DiseasesSchool of Public HealthXiamen UniversityXiamenFujian361102China School of Public Health Xiamen UniversityXiamenFujian361102China School of Life Science Xiamen UniversityXiamenFujian361102China Xiamen Innovax Biotech Company XiamenFujian361005China

Thimerosal has been widely used as a preservative in drug and vaccine products for *** to the strong propensity to modify thiols in proteins,conformational changes could occur due to covalent bond formation between ethylmercury(a degradant of thimerosal)and *** a conformational change could lead to partial or even complete loss of desirable protein *** study aims to investigate the effects of thimerosal on the capsid stability and antigenicity of recombinant human papillomavirus(HPV)18 virus-like particles(VLPs).Dramatic destabilization of the recombinant viral capsid upon thimerosal treatment was *** a negative effect on the thermal stability of VLPs preserved with thimerosal was shown to be dependent on the thimerosal *** highly neutralizing antibodies,13H12 and 3C3,were found to be the most sensitive to thimerosal *** kinetics of antigenicity loss,when monitored with 13H12 or 3C3 as probes,yielded two distinctly different sets of kinetic parameters,while the data from both monoclonal antibodies(mAbs)followed a biphasic exponential decay *** potential effect of thimerosal on protein function,particularly for thiolcontaining proteinaceous active components,needs to be comprehensively characterized during formulation development when a preservative is necessary.

关键词： Thiol-modifying agent Monoclonal antibody Antigenicity loss Epitope-specific Conformational stability

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

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苏州阳山下蜀粘土的改良及填筑试验

路基工程 2008年第1期 101-103页

作者：赵勤俭中铁二局股份有限公司四川成都610031

介绍苏州阳山下蜀粘土掺入生石灰改良作为路基填料,通过室内试验及填筑试验分析相关参数的选用,以验证其作为高速铁路路基下部填料的可行性。

关键词：下蜀粘土改良高速铁路路基填料

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磷酸钙纳米颗粒在疫苗佐剂中的研究进展

中华微生物学和免疫学杂志 2016年第1期36卷 66-71页

作者：林雅华王鑫赵勤俭厦门大学分子疫苗学与分子诊断学国家重点实验室厦门大学国家传染病诊断试剂与疫苗工程技术研究中心厦门大学公共卫生学院361102

佐剂作为疫苗的关键成分，能增强疫苗抗原特异的免疫原性、改变免疫应答类型、减少抗原用量从而以备疾病大流行之需，并降低疫苗价格。随着纳米技术的快速发展，纳米材料应用于开发有效、安全的疫苗佐剂方面的研究，也逐渐获得进展。磷... 详细信息

佐剂作为疫苗的关键成分，能增强疫苗抗原特异的免疫原性、改变免疫应答类型、减少抗原用量从而以备疾病大流行之需，并降低疫苗价格。随着纳米技术的快速发展，纳米材料应用于开发有效、安全的疫苗佐剂方面的研究，也逐渐获得进展。磷酸钙纳米颗粒凭借其良好的生物学性质：颗粒均一性和稳定性、生物相容性、生物可降解性、刺激机体产生体液免疫／细胞免疫等，并易于开展商业化规模制备，有潜力被开发成为疫苗佐剂。本文阐述了磷酸钙纳米颗粒作为一种新型佐剂在疫苗中的效应及其表面修饰的研究进展，为研发高效、安全的疫苗佐剂提供新的思路。

关键词：磷酸钙纳米颗粒佐剂活性疫苗佐剂免疫增强

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JC病毒检测方法研究进展及对比

中华微生物学和免疫学杂志 2016年第5期36卷 396-400页

作者：张彩黄小芬王鑫赵勤俭厦门大学生命科学学院分子疫苗学和分子诊断学国家重点实验室国家传染病诊断试剂与疫苗工程技术研究中心361102 厦门大学公共卫生学院分子疫苗学和分子诊断学国家重点实验室国家传染病诊断试剂与疫苗工程技术研究中心361102

JC病毒（John Cunningham virus, JCV）属于乳多空病毒科（Papovaviridae）多瘤病毒属（Orthopolyomavirus），1971年从进行性多灶性白质脑病（progressive multifocal leukoencephalopathy, PML）患者的脑中分离并以该患者名字命名，普通人群血清阳性检测率为40%～60%，因AIDS并发PML的患者致死率约为50%，对于免疫力缺陷和免疫力低下的既往感染者，还会引起多瘤病毒相关性肾病（polyomavirus-associated nephropathy, PVAN）、病毒血症等相关疾病，并与胃癌、肺癌、食管癌等癌症的发生密切相关，但其致病机理尚未阐明。由于目前无特异的预防和治疗方法，因此在病毒感染早期的准确检测对疾病的诊断和治疗十分关键，尤其在免疫低下的人群中实现高效、精准、及时的检测至关重要。本文对现有JC病毒的检测技术进行了分析与总结，一些新兴技术的涌现将为实现临床上快速、高效的检测提供参考。

关键词： JC病毒进行性多灶性白质脑病多瘤病毒肾病病毒检测方法

寨卡病毒病毒学特征及其引发异常免疫应答机制的研究进展

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中华微生物学和免疫学杂志 2016年第4期36卷 316-320页

作者：曹璐王鑫张志刚赵勤俭厦门大学分子疫苗学与分子诊断学国家重点实验室厦门大学国家传染病诊断试剂与疫苗工程技术研究中心厦门大学公共卫生学院361102

由寨卡病毒感染引起的寨卡病毒病是一种自限性急性传染病，主要通过伊蚊叮咬传播，也可以垂直传播，最近也有性传播的一些证据。随着寨卡病毒的暴发，对寨卡病毒的认识具有重要的意义。本文就寨卡病毒的传播与暴发史、病原学特征、诊断... 详细信息

由寨卡病毒感染引起的寨卡病毒病是一种自限性急性传染病，主要通过伊蚊叮咬传播，也可以垂直传播，最近也有性传播的一些证据。随着寨卡病毒的暴发，对寨卡病毒的认识具有重要的意义。本文就寨卡病毒的传播与暴发史、病原学特征、诊断与治疗、寨卡病毒感染与新生儿小头症的潜在相关性、引发细胞自噬等异常免疫应答的研究进展进行了综述。

关键词：寨卡病毒垂直传播新生儿小头症细胞自噬