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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 conditions.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 therapy.The progress on basic research of immunological principles and the boost of bioengineering facilitates the fast evolution of immunotherapy in recent years.Immunotherapy has changed the landscape of healthcare and promoted some advanced concepts to control diseases in medicine.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

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A review of the safety and efficacy of current COVID-19 vaccines

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Frontiers of Medicine 2022年第1期16卷 39-55页

作者： Zehong Huang Yingying Su Tianying Zhang Ningshao Xia State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics National Institute of Diagnostics and Vaccine Development in Infectious DiseasesStrait Collaborative Innovation Center of Biomedicine and PharmaceuticsSchool of Public HealthXiamen UniversityXiamen 361102China

Vaccination is the most effective and feasible way to contain the coronavirus disease 2019(COVID-19)pandemic.The rapid development of effective COVID-19 vaccines is an extraordinary achievement.This study reviewed the efficacy/effectiveness,immunogenicity,and safety profile of the 12 most progressed COVID-19 vaccines and discussed the challenges and prospects of the vaccine-based approaches in a global crisis.Overall,most of the current vaccines have shown safety and efficacy/effectiveness during actual clinical trials or in the real-world studies,indicating a development of pandemic control.However,many challenges are faced by pandemic control in terms of maximizing the effect of vaccines,such as rapid vaccine coverage,strategies to address variants with immune escape capability,and surveillance of vaccine safety in the medium-and long-terms.

关键词： COVID-19 SARS-CoV-2 vaccine safety efficacy effectiveness immunogenicity

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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

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

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Current progress in the development of prophylactic and therapeutic vaccines

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Science China(Life Sciences) 2023年第4期66卷 679-710页

作者： Tingting Li Ciying Qian Ying Gu Jun Zhang Shaowei Li Ningshao Xia State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics School of Life SciencesSchool of Public HealthXiamen UniversityXiamen 361102China National Institute of Diagnostics and Vaccine Development in Infectious Diseases Xiamen UniversityXiamen 361102China xiang An Biomedicine Laboratory Xiamen 361102China The Research Unit of Frontier Technology of Structural Vaccinology of Chinese Academy of Medical Sciences Xiamen 361102China

Vaccines are essential public health tools and play an important role in reducing the burden of infectious diseases in the population.Emerging infectious diseases and outbreaks pose new challenges for vaccine development,requiring the rapid design and production of safe and effective vaccines against diseases with limited resources.Here,we focus on the development of vaccines in broad fields ranging from conventional prophylactic vaccines against infectious diseases to therapeutic vaccines against chronic diseases and cancer,providing a comprehensive overview of recent advances in eight different vaccine forms(live attenuated vaccines,inactivated vaccines,polysaccharide and polysaccharide conjugate vaccines,recombinant subunit vaccines,virus-like particle and nanoparticle vaccines,polypeptide vaccines,DNA vaccines,and m RNA vaccines)and the therapeutic vaccines against five solid tumors(lung cancer,breast cancer,colorectal cancer,liver cancer and gastric cancer),three infectious diseases(human immunodeficiency virus,hepatitis B virus and human papillomavirus-induced diseases)and three common chronic diseases(hypertension,diabetes mellitus and dyslipidemia).We aim to provide new insights into vaccine technologies,platforms,applications and understanding of potential next-generation preventive and therapeutic vaccine technologies,paving the way for the vaccines design in the future.

关键词： prophylactic vaccine therapeutic vaccine immune response infectious diseases cancers chronic diseases

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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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Potential use of serum HBV RNA in antiviral therapy for chronic hepatitis B in the era of nucleos（t）ide analogs

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Frontiers of Medicine 2017年第4期11卷 502-508页

作者： Fengmin Lu Jie Wang xiangmei Chen Dongping Xu Ningshao Xia State Key Laboratory of Natural and Biomimetic Drugs Department of Microbiology & Infectious Disease Center School of Basic Medical Sciences Peking University Health Science Center Beijing 100191 China Institute of Infectious Diseases Beijing 302 Hospital Beijing 100039 China State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics School of Public Health Xiamen UniversityXiamen 361102 China

Although the efficacy of nucleos（t）ide analogue （NA） has been confirmed for treatment of chronic hepatitis B, long-term therapy has been recommended due to the high frequency of off-therapy viral DNA rebound and disease relapse. In this review, the RNA virion-like particles of hepatitis B virus （HBV） are integrated into the Hfe cycle of HBV replication, and the potential significance of serum HBV RNA is systematically described. The production of HBV RNA virion-like particles should not be blocked by NA; in this regard, serum HBV RNA is found to be a suitable surrogate marker for the activity of intrahepatic covalently closed circular DNA （cccDNA）, particularly among patients receiving NA therapy. Therefore, the concept of virological response is redefined as persistent loss of serum HBV DNA and HBV RNA. In contrast to hepatitis B surface antigen （HBsAg） that can originate from either the cccDNA or the integrated HBV DNA fragment, serum HBV RNA, with pregenomic RNA origination, can only be transcribed from cccDNA. Therefore, the loss of serum HBV RNA would likely be a promising predicator for safe drug discontinuation. The clinical status of consistent loss of serum HBV RNA accompanied with low serum HBsAg levels might be implicated as a ＂para-functional cure,＂ a status nearly close to the functional cure of chronic hepatitis B, to distinguish the ＂functional cure＂ characterized as serum HBsAg loss with or without anti-HBs seroconversion.

关键词： chronic hepatitis B serum HBV RNA nucleos（t）ide analogs virological response para-functional cure

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Current progress and challenges in the design and development of a successful COVID-19 vaccine

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Fundamental Research 2021年第2期1卷 139-150页

作者： Tingting Li Tianying Zhang Ying Gu Shaowei Li Ningshao Xia State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics School of Life SciencesSchool of Public HealthXiamen UniversityXiamen 361102China National institute of Diagnostics and Vaccine Devdopment in infecrious Disease xiamen UniversityXiamen 361102China

The coronavirus disease 2019(COVID-19)pandemic,caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2),is still a worldwide concern,with little to no sign of a decreasing trend.There is a general consensus that normal life will be hampered until a safe and effective vaccine strategy is available and globally administered.Numerous countries have accelerated the clinical trials process for the development of a successful COVID-19 treatment,with over 200 candidates presently available for testing against SARS-CoV-2.Here,we provide an overview of the COVID-19 vaccine candidates currently in development,discuss the scientific and practical challenges associated with COVID-19 vaccine design,and share the potential strategies that could be exploited for vaccine design success.

关键词： Coronavirus SARS-CoV-2 COVID-19 Vaccine Immunopathology Immune response

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SAMD4 family members suppress human hepatitis B virus by directly binding to the Smaug recognition region of viral RNA

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Cellular & Molecular Immunology 2021年第4期18卷 1032-1044页

作者： Yuze Wang Xinrui Fan Yunlong Song Yifei Liu Ruixin Liu Jianfeng Wu xiaoling Li Quan Yuan Guo Fu Ningshao Xia Jiahuai Han State Key Laboratory of Cellular Stress Biology Innovation Center for Cell Signaling NetworkSchool of Life SciencesXiamen UniversityXiamenFujian 361102China State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics National Institute of Diagnostics and Vaccine Development in Infectious DiseasesSchool of Public HealthXiamen UniversityXiamenFujian 361005China Cancer Research Center of xiamen University Xianmen Hospital of Xiamen UniversitySchool of MedicineXiamen UniversityXiamenFujian 361102China

HBV infection initiates hepatitis B and promotes liver cirrhosis and hepatocellular carcinoma.IFN-α is commonly used in hepatitis B therapy,but how it inhibits HBV is not fully understood.We screened 285 human interferon-stimulated genes(ISGs)for anti-HBV activity using a cell-based assay,which revealed several anti-HBV ISGs.Among these ISGs,SAMD4A was the strongest suppressor of HBV replication.We found the binding site of SAMD4A in HBV RNA,which was a previously unidentified Smaug recognition region(SRE)sequence conserved in HBV variants.SAMD4A binds to the SRE site in viral RNA to trigger its degradation.The SAM domain in SAMD4A is critical for RNA binding and the C-terminal domain of SAMD4A is required for SAMD4A anti-HBV function.Human SAMD4B is a homolog of human SAMD4A but is not an ISG,and the murine genome encodes SAMD4.All these SAMD4 proteins suppressed HBV replication when overexpressed in vitro and in vivo.We also showed that knocking out the Samd4 gene in hepatocytes led to a higher level of HBV replication in mice and AAV-delivered SAMD4A expression reduced the virus titer in HBVproducing transgenic mice.In addition,a database analysis revealed a negative correlation between the levels of SAMD4A/B and HBV in patients.Our data suggest that SAMD4A is an important anti-HBV ISG for use in IFN therapy of hepatitis B and that the levels of SAMD4A/B expression are related to HBV sensitivity in humans.

关键词： ISG Hepatitis B virus SAMD4 family proteins RNA degradation

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A novel therapeutic anti-HBV antibody with increased binding to human FcRn improves in vivo PK in mice and monkeys

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Protein & Cell 2018年第1期9卷 130-134页

作者： Ciming Kang Lin xia Yuanzhi Chen Tianying Zhang Yiwen Wang Bing Zhou Min You Quan Yuan Chi-Meng Tzeng Zhiqiang An Wenxin Luo ningshao xia Texas Therapeutics Institute The Brown Foundation Institute of Molecular Medicine University of Texas Health Science Center at Houston Houston USA

Antibody immunotherapy is a well-established therapeutic modality for cancer, acute viral infections （Marasco and Sui, 2007） and persistent viral infection such as HIV （Barouch et al., 2013） and HCMV （Freed et al., 2013）. To reduce immunogenicity of rodent antibodies （Abs）, approved anti-body drugs entering clinical trials are of human origin or are humanized versions of rodent antibodies （Reichert, 2008）.

关键词： HALF-LIFE HUMAN IGG1 MONOCLONAL-ANTIBODIES RECEPTOR

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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)infection.Such mice with primary human hepatocyte(PHH)transplantation are adequate to support chronic HBV infection for several weeks and to evaluate antiviral drugs.However,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 alternatives.Here,we transplanted primary tupaia hepatocytes(PTHs)into the livers of immunodeficient mice and achieved high liver chimerism within six weeks.These 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 infection.In 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

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