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Science Bulletin 2024年第4期69卷 512-525页

作者：王致萍王大宁陈洁高飞江雅楠杨澄宇钱兹英池鑫张姝玥许钰洁卢一涵沈璟佳张承宗李瑾瑾周立志李婷婷郑清炳俞海李少伟夏宁邵顾颖 State Key Laboratory of Vaccines for Infectious Diseases Xiang An Biomedicine LaboratorySchool of Life SciencesSchool of Public HealthXiamen UniversityXiamen 361102China National Institute of Diagnostics and Vaccine Development in Infectious Diseases State Key Laboratory of Molecular Vaccinology and Molecular DiagnosticsCollaborative Innovation Center of Biologic ProductsNational Innovation Platform for Industry-Education Integration in Vaccine ResearchXiamen UniversityXiamen 361102China Research Unit of Frontier Technology of Structural Vaccinology Chinese Academy of Medical SciencesXiamen 361102China xiamen innovax biotech Co. Ltd.Xiamen 361022China

In vaccine development,broadly or cross-type neutralizing antibodies(bnAbs or cnAbs)are frequently targeted to enhance *** immunodominant antibodies could help fine-tune vaccine immunogenicity and augment the precision of immunization ***,the methodologies to capitalize on the attributes of bnAbs in vaccine design have not been clearly *** this study,we discovered a cross-type neutralizing monoclonal antibody,13H5,against human papillomavirus 6(HPV6)and *** nAb exhibited a marked preference for HPV6,demonstrating superior binding activity to virus-like particles(VLPs)and significantly higher prevalence in anti-HPV6 human serum as compared to HPV11 antiserum(90%vs.31%).Through co-crystal structural analysis of the HPV6 L1 pentamer:13H5 complex,we delineated the epitope as spanning four segments of amino acids(Phe42-Ala47,Gly172-Asp173,Glu255-Val275,and Val337-Tyr351)on the L1 surface *** interaction analysis and site-directed mutagenesis revealed that the Ser341 residue in the HPV6 HI loop plays a critical role in the interaction between 13H5 and *** Ser341 with alanine,which is the residue type present in HPV11 L1,almost completely abolished binding activity to *** swapping amino acids in the HPV11 HI loop with corresponding residues in HPV6 L1(Ser341,Thr338,and Thr339),we engineered chimeric HPV11-6HI ***,the chimeric HPV11-6HI VLPs shifted the high immunodominance of 13H5 from HPV6 to the engineered VLPs and yielded comparable neutralization titers for both HPV6 and HPV11 in mice and non-human *** approach paves the way for the design of broadly protective vaccines from antibodies within the main immunization reservoir.

关键词： Human papillomavirus Cross-neutralization antibody Immunodominance shift Vaccine design

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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

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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

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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

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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（英文）

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Science Bulletin 2023年第20期 2448-2455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 Province 2. State Key Laboratory of Vaccines for Infectious Diseases Xiang An Biomedicine Laboratory School of Public Health Xiamen University 3. National Institute of Diagnostics and Vaccine Development in Infectious Diseases State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics National Innovation Platform for Industry-Education Integration in Vaccine Research NMPA Key Laboratory for Research and Evaluation of Infectious Disease Diagnostic Technology Xiamen University National Institutes for Food and Drug Control xiamen innovax biotech company 6. Dongtai Center for Disease Control and Prevention

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...

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.

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