肺炎球菌结合疫苗研发策略

The strategy in development of pneumococcal conjugate vaccine

安全有效的肺炎球菌结合疫苗(pneumococcal conjugate vaccine,PCV)已成为预防婴幼儿肺炎球菌感染的主要手段。目前Prevenar7~■、Synflorix~■和Prevenar13~■的先后上市,仍不能满足全球婴幼儿及高危人群预防肺炎球菌感染的需求,这一需求促进了国内外对PCV疫苗的研发。各研究机构采用的结合技术各不相同,但在PCV制备中需考虑的因素有据可循。现对PCV研发策略中需考虑的血清型、多糖相对分子质量大小、载体蛋白、结合化学的选择,以及中间质控监测和结合物表征方法的选择等作一概述,为新型PCV研发提供参考。

The safety profiles and effectiveness make pneumococcal conjugate vaccine(PCV)as the major measurements to prevent pneumococcal infection among youngers and others from high risk populations.The supplies of PCVs currently in the markets,including Prevenar 7~■,Synflorix~■and Prevenar 13~■can not meet the global vaccine needs.Considerable resources have been devoted in development of new PCVs.Despite of the various approaches taken by different institutes,there are many common factors which need to be considered.In this paper,we try to review the general principles in development for novel PCVs,such as serotypes covered in the vaccines,the molecular size of polysaccharides utilized,the selection of carrier proteins,process involved in control measurements and quality control issues.