默沙东15价肺炎球菌结合疫苗2项III期研究成功,计划年底申请上市

2020-11-04 医药魔方 医药魔方

默沙东宣布其15价肺炎球菌结合疫苗V114 (PCV15) 在PNEU-PATH (V114-016) 和 PNEU-DAY (V114-017)这2项III期研究中取得积极结果,且安全性和耐受性良好

默沙东宣布其15价肺炎球菌结合疫苗V114 (PCV15) 在PNEU-PATH (V114-016) 和 PNEU-DAY (V114-017)这2项III期研究中取得积极结果,且安全性和耐受性良好。

肺炎球菌疾病是一种由肺炎球菌感染所引起的疾病类型,其中包括肺炎、鼻窦炎和中耳炎等非侵入性疾病、以及脑膜炎等的侵入性疾病。肺炎球菌有90多种不同类型,它们对成人和儿童影响不同。研究发现,血清型22F和33F引起的侵袭性肺炎球菌疾病与较高的病死率和成人住院时间延长相关。V114包含13价肺炎球菌多糖结合疫苗(PCV13)的全部血清型,同时增加了两种额外的血清型(22F和33F)。

默沙东此次公布的PNEU-PATH研究共纳入652例50岁以上健康成人,随机接种V114或PCV13疫苗,并在一年后接种Pneumovax 23疫苗。结果显示,2个接种组在接种Pneumovax 23疫苗后对于V114中的15种血清型免疫应答相当。另外,接种V114或PCV13第30天,2组受试者对于疫苗中共有的13个血清型免疫应答相当,V114组受试者对于22F和33F血清型免疫应答更高。

PNEU-DAY研究共纳入1512例18-49岁的受试者,这些受试者因基础疾病或生活习惯导致肺炎球菌疾病风险增加。入组受试者随机接种了V114或PCV13疫苗,并在6个月后接种了Pneumovax 23疫苗。结果显示,V114组与PCV13组受试者对于共有的13种血清型方面免疫应答相当,V114组受试者对于22F和33F血清型免疫应答更高。

默沙东表示,针对V114的III期临床项目计划共包括16项临床试验,这些研究的详细数据将在未来的医学大会上进行公布。同时,默沙东计划在年底向全球提交监管申请。

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    2021-03-16 juliusluan78
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    2020-11-09 ms8000001754662727

    谢谢分享

    0

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    2020-11-05 yese
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    2020-11-05 刘煜

    阅读谢谢分享

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