更新于：2024-11-21

Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero cell)(Sinovac Life Sciences)

Sabin株脊髓灰质炎灭活疫苗(Vero细胞) (北京科兴)

更新于：2024-11-21

概要

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

Inactivated poliovirus vaccine - Intravacc/Sinovac/WHO、Poliovirus inactivated vaccine - Intravacc/Sinovac/WHO、Poliovirus vaccine inactivated - Intravacc/Sinovac/WHO

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靶点-

作用机制

免疫刺激剂

治疗领域

感染神经系统疾病其他疾病

在研适应症

脊髓灰质炎

非在研适应症-

原研机构

北京科兴中维生物技术有限公司

在研机构

北京科兴生物制品有限公司

北京科兴中维生物技术有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2021-07-12),

脊髓灰质炎

最高研发阶段(中国)批准上市

特殊审评-

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关联

项与 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) (北京科兴) 相关的临床试验

NCT06442449 / Not yet recruiting临床4期

Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of sIPV Co-administered With MMR and HepA-I.

This is an Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine (Vero cell) (sIPV) Co-administered with Measles, Mumps, Rubella (MMR) Combined Live Attenuated Vaccine and Inactivated Hepatitis A (Hep-A) Vaccine.

开始日期2024-07-10

申办/合作机构

北京科兴生物制品有限公司

NCT06346834 / Not yet recruiting临床4期

A Study to Evaluate the Immunogenicity and Safety of Sequential Vaccination Among Infants With Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains （Hereinafter as "sIPV") From Different Manufacturers.

To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.

开始日期2024-04-30

申办/合作机构

北京科兴生物制品有限公司

NCT05850364 / Recruiting临床3期

A Multi-country, Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sabin Strain Inactivated Poliovirus Vaccine Administered With or Without Routine Infant Vaccines

This study is designed to study the immunogenicity and safety of sIPV co-administered with other routine infant vaccines. According to the national immunization schedule of Bangladesh and Pakistan, sIPV was administered concomitantly with PCV10, DTP-HeB-Hib and other vaccines at 6, 10 and 14 weeks old. Thus, this study set up the concomitant vaccination schedule according to the real practice in study area. The primary hypothesis of this study is the seroconversion rate of polio vaccination when administered concomitantly with routine vaccines, is non-inferior to that when administered alone; the secondary hypothesis of this study is the seropositivity rate of diphtheria, tetanus, and pertussis when routine vaccines are administered concomitantly with sIPV, is non-inferior to that administered without sIPV.

开始日期2023-05-22

申办/合作机构

北京科兴生物制品有限公司

100 项与 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) (北京科兴) 相关的临床结果

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100 项与 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) (北京科兴) 相关的转化医学

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100 项与 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) (北京科兴) 相关的专利（医药）

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项与 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) (北京科兴) 相关的文献（医药）

2021-05-04·Human Vaccines & Immunotherapeutics3区 · 医学

Safety and immunogenicity of a new Sabin inactivated poliovirus vaccine candidate produced on the PER.C6® cell-line: a phase 1 randomized controlled trial in adults

3区 · 医学

Article

作者: Leroux-Roels, Geert ; de Rooij, Richard ; Leroux-Roels, Isabel ; van Zeeburg, Hester ; Struijs, Martin ; Jacquet, Jeanne-Marie ; Shukarev, Georgi ; Cahill, Conor ; Schuitemaker, Hanneke

This first-in-human study (NCT03032588), conducted in Belgium, evaluated a new inactivated poliovirus vaccines (IPV) candidate based on Sabin poliovirus strains grown on the high-yield PER.C6® cell line. Healthy adults (N = 32) were randomized (1:1) to receive a single dose of PER.C6-based Sabin-IPV (sIPV, 15:35:112.5 DU/dose) or conventional Salk-IPV (cIPV, 40:8:32 DU/dose). Reactogenicity was assessed up to 7 days after vaccination, immunogenicity 28 days after vaccination, and safety up to 6 months after vaccination.Solicited adverse events (AEs) were mild to moderate, no changes of concern in vital signs or safety laboratory values were observed, and no severe AEs (SAEs) or vaccine-related unsolicited AEs were reported after vaccination. A trend to more frequent solicited AEs after sIPV than after cIPV administration was observed. Most participants had preexisting neutralizing antibodies against poliovirus types (titer ≥8), which were strongly boosted by sIPV. Post-vaccination geometric mean titers were high (≥12,000) and similar across the two vaccination groups. Only participants with very high preexisting antibody levels did not show a vaccine-induced response, defined in seropositive participants as a 4-fold titer increase. The 10 initially seronegative (titer <8) participants (n = 5 in each study group) seroconverted and all participants had seroprotective antibody levels post-vaccination. The antibodies elicited by sIPV neutralized both Sabin and Salk poliovirus strains.In conclusion, the PER.C6®-based sIPV was well tolerated and highly immunogenic in adults with preexisting antibodies to poliovirus.

2021-05-01·Journal of Pharmaceutical Sciences3区 · 医学

Physicochemical Characterization of Sabin Inactivated Poliovirus Vaccine for Process Development

3区 · 医学

Article

作者: Shikama, Saori ; Maruno, Takahiro ; Torisu, Tetsuo ; Uchiyama, Susumu ; Nakamura, Kuniaki ; Mori, Asuka ; Enomoto, Kanta ; Satou, Tatsuki

Upscaling the production capacity of inactivated poliovirus vaccines (IPV) is urgently needed to eradicate polio worldwide. For the development of a robust manufacturing process for IPV, the impact of stresses on the properties of the poliovirus during manufacturing needs to be carefully evaluated. In this study, the physicochemical properties of Sabin poliovirus after low pH exposure were analyzed by asymmetrical flow field-flow fractionation coupled to multi-angle laser light scattering (AF4-MALS), sedimentation velocity analytical ultracentrifugation (SV-AUC), transmission electron microscopy (TEM), dynamic light scattering (DLS) and surface plasmon resonance (SPR). Low pH stress caused structural changes and aggregation of inactivated poliovirus virions, whereas degraded virion particles would not revert to native virions even after neutralization. Importantly, a complete loss of the D-antigenicity of IPV by low pH stress, followed by neutralization, was observed in SPR. These results suggest that the exposure of poliovirus particle to low pH stress would induce irreversible denaturation and aggregation of virus particles and lead to the loss of D-antigenicity; thus, low pH stress during the manufacturing of poliovirus vaccine should be minimized. The analytical methods above can be efficiently utilized in the development of high-integrity manufacturing processes and high-quality vaccines.

2021-04-01·Vaccine3区 · 医学

Immunogenicity and safety of sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine: An innovative application of different strain-IPVs replacement

3区 · 医学

Article

作者: Chen, Haiping ; Yang, Xiaoming ; Han, Shasha ; Gao, Zhigang ; Liu, Xiaoqin ; Sun, Hongmei ; Bai, Shuang ; Xiao, Yanhui ; Yu, Yinghong ; Liu, Fang

BACKGROUNDA domestic Sabin strain-based inactivated poliovirus vaccine (Sabin IPV) was approved by China Food and Drug Administration in 2017 as a replacement for the Salk strain-based inactivated poliovirus vaccine (Salk IPV) that has been in use in China for over 10 years. The present post-marketing trial was implemented in China to assess the immunogenicity and safety of replacing the Salk IPV with the Sabin IPV in the last two immunizations of the standard three-dose schedule.METHODSWe conducted a randomized, controlled clinical trial with two groups that received three doses of IPVs at the age of 2, 3, and 4 months: the Salk-Sabin-Sabin group and the Salk-Salk-Salk group. Blood samples were collected before vaccination and 30-40 days after the third dose of vaccination. The seroconversion rates and antibody geometric mean titers (GMTs) were calculated and analyzed to evaluate immunogenicity. The safety of both immunization schedules was also monitored and analyzed.RESULTSOf 360 recruited healthy infants, all three IPV doses were administered and blood collection was completed in 330 infants. All participants (100%) in both groups were seropositive for all three poliovirus types after the last vaccination. There were significant differences between the two groups (P < 0.001) in the GMTs for antibodies against poliovirus types 1 and 2, but no significant difference was observed for antibodies against type 3 (P = 0.009). A non-inferiority t-test showed that the post-immunization GMTs for all three types in the Salk-Sabin-Sabin group were not inferior to those in the Salk-Salk-Salk group (P < 0.001). Safety assessment indicated that there was no significant difference in the incidence of all adverse events between the two groups (P = 0.806).CONCLUSIONSThe Salk-Sabin-Sabin IPV immunization schedule is not inferior to the Salk-Salk-Salk IPV schedule in terms of both immunogenicity and safety. Clinical trial number: NCT04051736.

项与 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) (北京科兴) 相关的新闻（医药）

2024-11-17

·SINOVAC科兴

秘鲁一年内批准上市三款SINOVAC科兴疫苗

近日，SINOVAC科兴脊髓灰质炎灭活疫苗获得秘鲁药品、器械与药物理事会（General Directorate of Medicines, Supplies and Drugs ，DIGEMID）注册批准，这也是今年以来SINOVAC科兴第三款疫苗在该国获得注册批准。这体现了秘鲁对科兴疫苗的高度认可，将对推动中秘两国关系健康稳定发展发挥独特作用。 2024年8月，SINOVAC科兴甲型肝炎灭活疫苗（儿童剂型和成人剂型）及水痘减毒活疫苗陆续获得秘鲁药品、器械与药物理事会注册批准。迄今为止，SINOVAC科兴的多款疫苗已在拉美11个国家获得注册批准。今年10月至11月，SINOVAC科兴质量委员会主席、国际业务负责人孟伟宁，拉美业务拓展总监唐子健等带领团队先后走访了巴西、哥伦比亚、阿根廷、智利、多米尼加和秘鲁六国，围绕免疫规划和疫苗采购策略与各国政府机构及相关人士进行了充分交流，为进一步合作奠定坚实基础。国际化发展战略是SINOVAC科兴致力于可持续、高质量发展的战略方向，而拉美则是公司重要的发展区域。孟伟宁表示，公司将坚定不移地扎根拉美，加强团队人才建设，加大合作投入，为拉美地区提供高质量、可负担的疫苗，更好地助力拉美各国疾病防控，从而为包括中秘在内的中拉关系长期稳定发展添砖加瓦。

上市批准疫苗

2024-10-15

·微信

SINOVAC科兴一批脊灰疫苗运往泰国，助力当地脊灰防控

近日，一批由SINOVAC科兴旗下北京科兴生物制品有限公司生产的Sabin株脊髓灰质炎灭活疫苗（sIPV）运往泰国，助力当地脊灰防控。SINOVAC科兴sIPV于今年1月在泰国获得了注册批准，此后在泰国政府的疫苗招标项目中成功中标，以支持泰国根除脊灰项目。 SINOVAC科兴sIPV于2022年6月通过世卫组织（WHO）预认证，5人份sIPV也于今年9月通过了WHO预认证。今年参与泰国竞标是SINOVAC科兴sIPV首次参与国际政府采购项目，成功中标后，公司迅速安排疫苗的生产和运输，确保按时向泰国交付疫苗，及时助力当地脊灰防控工作。 2014年3月27日，世卫组织东南亚区域被认证为无脊灰地区，这意味着野生脊灰病毒的传播在该区域包括泰国在内的 11 个国家中已经得到阻断。为了巩固这一来之不易的公共卫生成就，泰国持续保持高水平的脊灰疫苗接种率。泰国现行的儿童免疫规划要求，婴儿在2月龄和4月龄时各接种1剂IPV，并在6月龄、18月龄和4岁时各口服1剂OPV。通过科学的疫苗接种计划，泰国有效预防了脊灰的卷土重来。

疫苗带量采购

2024-10-11

·SINOVAC科兴

以信为本，从共享走向共赢，实现更大价值创造——SINOVAC科兴财务共享中心成功上线

2024 年 10 月 11 日，SINOVAC 科兴财务共享中心上线启动仪式在大连举行。SINOVAC科兴董事长、总裁兼 CEO 尹卫东通过视频连线在启动仪式上致辞，公司副总裁兼首席财务官王楠，公司副总裁、北京科兴生物制品有限公司总经理李静及公司商务总经理田园等出席启动仪式。尹卫东董事长对共享中心成功上线表示祝贺我们进行共享的目的是为了实现共赢。SINOVAC科兴经过20多年的发展实现了价值创造，这不单单体现在创造股东价值上，更重要的是创造社会价值。目前共享中心的建设是企业集团化发展战略目标的重要一环，接下来各个环节都在此基础上，环环相扣，紧密相连。科兴人一直保持创业的心态，我们将在信用的基础上共享，在信心的基础上共创，在彼此信任的基础上共生，在“为人类消除疾病”的共同信仰的基础上创造更大的企业价值与社会价值，从而最终实现共赢。王楠总表示，虽然过去20多年来科兴进行了很好的价值创造，但是科兴人不会就此停下创造价值的脚步。目前，公司正在启动集团化管控项目，这将为公司在新的发展阶段进行新的价值创造提供坚实的保障，而财务共享中心的落地标志着公司在新时期向新的价值创造阶段迈出了坚实的第一步。李静总代表集团各子公司表态，财务共享是实现集团化管理非常重要的一步，各子公司都大力支持，并且已经着手梳理汇总各自数据来推进集团财务共享，相信这将进一步提高公司整体价值创造效率。财务共享是SINOVAC科兴推进集团一体化高质量发展的重要“先手棋”。财务共享中心的顺利启动将带动集团其他重要业务板块的管理创新和系列变革，推动集团一体化发展的历史性突破，创造更大的企业价值和社会价值，以共享为始最终实现共赢！关于SINOVAC科兴/产品介绍科兴控股生物技术有限公司（Sinovac Biotech Ltd.，SINOVAC科兴）是中国领先的生物高新技术企业，以“为人类消除疾病提供疫苗”为使命，致力于人用疫苗及其相关产品的研究、开发、生产和销售，为全球疾病预防控制提供服务。 SINOVAC科兴研制的疫苗主要包括针对病毒性肝炎、流感、肺炎、脊髓灰质炎、水痘、腮腺炎等常见传染病的疫苗以及针对SARS、甲型H5N1高致病性禽流感、甲型H1N1流感大流行、EV71相关手足口病、新型冠状病毒感染等新发、突发传染病的疫苗。公司现有4款疫苗通过世界卫生组织预认证（甲肝灭活疫苗、Sabin株脊髓灰质炎灭活疫苗、水痘减毒活疫苗）或列入紧急使用清单（新型冠状病毒灭活疫苗），疫苗质量管理体系获国际组织和多国药监部门认可。未来，SINOVAC科兴将继续聚焦于生物医药领域的科学创新，通过自主研发以及对外投资、合作等多种方式推动更多高品质生物医药产品更快地实现产业化落地，用于满足全球的疾病防治需求，助力提升全球健康福祉。

疫苗

100 项与 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) (北京科兴) 相关的药物交易

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