国内**新冠病毒重组蛋白亚单位疫苗启动III期临床

2020-12-04 医药魔方 医药魔方

12月3日,中科院微生物所与智飞生物联合研制的新冠病毒重组蛋白亚单位疫苗,在完成I/II期临床试验基础上,近日已启动III期临床试验准备工作。

12月3日,中科院微生物所与智飞生物联合研制的新冠病毒重组蛋白亚单位疫苗,在完成I/II期临床试验基础上,近日已启动III期临床试验准备工作。

新冠病毒重组蛋白亚单位疫苗III期临床试验将在18周岁及以上人群中开展,采取随机、双盲、安慰剂对照的国际多中心临床试验,全球共计划招募2.9万人。目前,中科院微生物所和智飞生物正积极推动该疫苗在乌兹别克斯坦、印度尼西亚、巴基斯坦、厄瓜多尔的III期临床试验。

这款新冠疫苗于6月19日获得国家药品监督管理局的临床试验批件。从6月23日开始,在北京市、重庆市、湖南省三地招募18岁以上的健康成年人,相继开展了随机、双盲、安慰剂对照的I、II期临床试验。

10月22日,I、II期临床试验安全性和免疫原性关键数据揭盲,该疫苗在临床试验中显示出很好的安全性和免疫原性。11月4日,CDE召开了该疫苗III期临床试验方案沟通交流咨询会,III期临床方案获得完善和确认,安徽智飞龙科马公司可按申报的临床方案开展国际多中心III期临床试验。

据了解,安徽智飞龙科马公司已于9月获得了药品生产许可证变更,增加了重组新型冠状疫苗事项,新冠疫苗车间也于同月投入使用,试生产顺利,可年产3亿剂以上。该疫苗采用与乙肝疫苗、戊肝疫苗、宫颈癌疫苗类似的技术路线,为“重组亚单位疫苗”,安全性好。

新冠病毒重组蛋白亚单位疫苗由中科院微生物所科研攻关团队研发,拥有自主知识产权,是中国科技抗疫在疫苗研发领域并行推进的五条技术路线之一。

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    2021-09-27 juliusluan78
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    2021-07-11 ms9000002070139431

    疫苗持续时间是多久

    0

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    2020-12-05 xqptu
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    2020-12-04 2451377768

    期待

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1653133, encodeId=6770165313356, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Sun Jul 04 11:00:02 CST 2021, time=2021-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916379, encodeId=802819163e9b8, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Sep 27 23:00:02 CST 2021, time=2021-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=998552, encodeId=1e1f99855217, content=疫苗持续时间是多久, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2bbb5467385, createdName=ms9000002070139431, createdTime=Sun Jul 11 18:55:30 CST 2021, time=2021-07-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1384709, encodeId=db851384e098f, content=<a href='/topic/show?id=5c74e7739f0' target=_blank style='color:#2F92EE;'>#组蛋白#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77739, encryptionId=5c74e7739f0, topicName=组蛋白)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ea13490, createdName=xqptu, createdTime=Sat Dec 05 15:00:02 CST 2020, time=2020-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524902, encodeId=a631152490264, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sat Dec 05 15:00:02 CST 2020, time=2020-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594841, encodeId=3b54159484120, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Dec 05 15:00:02 CST 2020, time=2020-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=904880, encodeId=f66790488088, content=期待, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201204/c83bcfc1404d4e8da6b6092d0aa15002/6836d45b0e284b62b7ce9397c7547600.jpg, createdBy=15092993043, createdName=2451377768, createdTime=Fri Dec 04 15:55:22 CST 2020, time=2020-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1028847, encodeId=4ffa102884ebd, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Fri Dec 04 03:00:02 CST 2020, time=2020-12-04, status=1, ipAttribution=)]
    2020-12-04 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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