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翻译协作/结合疫苗--婴幼儿的保护伞

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    2018年2月2日,云南卫视发布了沃森生物国产首支13价肺炎球菌多糖结合疫苗新药生产获得国家食品药品管理监督总局受理的相关报道。报道指出;2018年2月1日,云南沃森生物技术股份有限公司自主研发的“13价肺炎球菌多糖结合疫苗”申请新药生产获得国家食品药品管理监督总局出具的受理通知书,这标志着疫苗已从临床研究阶段进入到最终的生产注册审评审批阶段,根据国家注册管理办法相关法规,疫苗申请新药生产获得受理后,还需经过技术审评、临床试验注册现场核查、生产现场检查等程序。在获得CFDA颁发的药品注册批件并通过GMP认证后,即能组织产品生产。产品获得批签发合格证后,即可上市销售。

    目前全国只有辉瑞一家生产该疫苗,沃森疫苗的有望上市,将会有希望打破美国的垄断。结合疫苗(以蛋白为载体的细菌多糖类)是指采用化学方法将多糖共价结合在蛋白载体上所制备成的多糖-蛋白结合疫苗,用于提高细菌疫苗多糖抗原的免疫原性。多糖与蛋白的结合技术是上世纪80年代以后发展起来的一项细菌性疫苗制造技术。它是细菌性疫苗发展史上的一次革命,开发了预防B型流感嗜血杆菌结合疫苗、脑膜炎双球菌、肺炎链球菌等细菌感染的一系列有效产品,对降低人群尤其是婴幼儿呼吸道传染病的发病率起到重要作用。

    2003年,由原兰州生物制品研究所研制的b型流感嗜血杆菌结合疫苗(商品名呵儿贝)获得批准,成为中国批准的首个国产结合疫苗品种。2006年,罗益生物制药有限公司研制的A群C群脑膜炎球菌结合疫苗获得批准。截至目前,中国批准的国产结合疫苗品种已有多项,如图所示。

    近几年上市的结合疫苗

    来源:药智网

    我们在欣喜中国科学家取得的傲人成绩的同时,也应该认识到国内研究的不足。在我国,目前肺炎多糖结合疫苗的接种人群还很大程度上依赖于国外产品,成本很高,接种完成要付出几千元的高额费用,使很多潜在患者望而却步,起不到全面预防的作用。现有结合疫苗的主要问题是制备过程复杂、成本价格高。未来对结合疫苗的进一步研究希望能解决以上问题。结合疫苗的研究需要我们更多的努力和心血。

    近期,我们平台特呼吁各位同行,朋友参与结合疫苗的翻译活动,以供大家更加深入的了解结合疫苗。只需要您花费一点儿宝贵的时间参与翻译,之后我们会进行总结,最终会将原文和译文全部呈现在平台上供大家学习交流。在此诚挚邀请业内各位精英,朋友积极参与,为结合疫苗的研究贡献自己的一份力量。请点击“阅读原文”,填写信息参与翻译协作!

    翻译目录
    一 肺炎球菌结合疫苗

    1.Clinical and microbiological characteristics of unusual manifestations of invasive pneumococcal disease.

    2.Serotype distribution of Streptococcus pneumoniae and potential impact of pneumococcal conjugate vaccines in China: A systematic review and meta-analysis.

    3..Effectiveness and practical uses of 23-valent pneumococcal polysaccharide vaccine in healthy and special populations.

    4.Review of vaccine effectiveness assumptions used in economic evaluations of infant pneumococcal conjugate vaccine.

    5.Pneumococcal Conjugate Vaccine and Pneumonia Prevention in Children with Congenital Heart Disease.

    6.Development of pneumococcal vaccines over the last 10 years.

    7.Pneumococcal Vaccination Among Medicare Beneficiaries Occurring After the Advisory Committee on Immunization Practices Recommendation for Routine Use Of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults Aged ≥65 Years.

    8.Pneumococcal conjugate vaccine implementation in middle-income countries.

    9.Impact of protein D-containing pneumococcal conjugate vaccines on non-typeable Haemophilus influenzae acute otitis media and carriage.

    10.Conjugation of PEG-hexadecane markedly increases the immunogenicity of pneumococcal polysaccharide conjugate vaccine.

    11.Comparative evaluation of a newly developed 13-valent pneumococcal conjugate vaccine in a mouse model.

    12.Immunogenicity of 13-Valent Conjugate Pneumococcal Vaccine in Patients 50 Years and Older with End-Stage Renal Disease and on Dialysis.

    13.Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study.

    14..A Review of Pneumococcal Vaccines: Current Polysaccharide Vaccine Recommendations and Future Protein Antigens

    二 脑膜炎球菌结合疫苗

    1. Serogroup B Meningococcus Outbreaks, Prevalence, and the Case for Standard Vaccination.

    2. The Establishment and Diversification of Epidemic-Associated Serogroup W Meningococcus in the African Meningitis Belt, 1994 to 2012.

    3. Serological Analysis of Immunogenic Properties of Recombinant Meningococcus IgA1 Protease-Based Proteins

    4. Bexsero, a novel vaccine against meningococcus

    5. How the Knowledge of Interactions between Meningococcus and the Human Immune System Has Been Used to Prepare Effective Neisseria meningitidis Vaccines.

    6. Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months

    7. Safety of Quadrivalent Meningococcal Conjugate Vaccine in Children 2-10 Years

    8. Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds.

    9. Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine.

    10. Technical Development of a New Meningococcal Conjugate Vaccine.

    11. A Licensed Combined Haemophilus influenzae Type b-Serogroups C and Y Meningococcal Conjugate Vaccine.

    12. Chemistry of a new investigational quadrivalent meningococcal conjugate vaccine that is immunogenic at all ages

    13. Update on prevention of meningococcal disease: focus on tetravalent meningococcal conjugate vaccine

    14. The new meningococcal conjugate vaccine. A profile of its safety, efficacy, and indications for use.

    15. Meningococcal conjugate vaccine in adolescents and children.

    三 b型流感病毒结合疫苗

    1.Haemophilus influenzae type b (Hib) seroprevalence and current epidemiology in England and Wales

    2.Comparing Haemophilus influenzae type b conjugate vaccine schedules: a systematic review and meta-analysis of vaccine trials

    3.Haemophilus influenzae type b (Hib) seroprevalence and current epidemiology in England and Wales.

    4.Impact of Haemophilus influenzae type b conjugate vaccination on hospitalization for invasive disease in children fifteen years after its introduction in Italy.

    5.Economic evaluations of Haemophilus influenzae type b (Hib) vaccine: a systematic review.

    7.Pediatric bacterial meningitis in Japan, 2013-2015 - 3-5 years after the wide use of Haemophilus influenzae type b and Streptococcus pneumoniae conjugated vaccines.

    四.伤寒结合疫苗

    1.First characterization of immunogenic conjugates of Vi negative Salmonella Typhi O-specific polysaccharides with rEPA protein for vaccine development.

    2.Preparation and testing of a Vi conjugate vaccine using pneumococcal surface protein A (PspA) from Streptococcus pneumoniae as the carrier protein.

    3.Working Group on quality, safety and efficacy of typhoid Vi capsular polysaccharide conjugate, vaccines, Jeju, Republic of Korea, 5-7 September 2012.

    4.Some information regarding the historical development of typhoid fever in Chile

    5.Vaccine, Typhoid

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