Nat Med:植物来源新冠疫苗的1期随机试验,结果值得期待

2021-05-22 haibei MedSci原创

第二剂后,CoVLP+AS03组的NAbs比新冠患者康复期血清的滴度高10倍以上。此外,穗蛋白特异性干扰素-γ和白细胞介素-4的细胞反应也都被诱导。

目前,新冠病毒的大流行已在全球范围内造成超过1.3亿例患者,其中有超过280万人死亡。尽管我们在新冠患者的治疗方面已经取得了相当大的进展,但目前的治疗方案仍然相对有限。从这一流行病开始,全球一直在努力开发疫苗。这种努力在某种程度上是由以前处理其他高致病性人类冠状病毒,比如SARS-CoV和中东呼吸道综合征冠状病毒,的经验以及流行病防备创新联盟的努力促成的。

据不完全统计,目前全球已经宣布了超过182种候选疫苗;其中,超过81种候选疫苗正在多达230项临床试验中进行测试;12种疫苗已经在至少一个司法管辖区获得某种程度的使用授权。这些疫苗和候选疫苗不仅在数量上令人瞩目,而且在多样性上也令人瞩目,它们包括了传统的(例如,灭活病毒、减毒活疫苗和蛋白质+佐剂)和新的(例如,mRNA、DNA和可复制和不可复制的病毒载体)平台。

最近,研究人员开发了在植物中生产的具备SARS-CoV-2穗状糖蛋白的病毒样颗粒候选疫苗,并公布了其在观察者盲法、剂量升级、随机对照研究中第42天的安全性和免疫原性数据(CoVLP:NCT04450004)。

该研究的共同主要结果是通过中和抗体(NAb)和细胞反应评估CoVLP制剂的短期耐受性/安全性和免疫原性。这项正在进行的研究的次要结果包括疫苗接种后12个月内的安全性和免疫原性评估。

CoVLP本身或与佐剂联合产生的体液反应

在这次临床试验中,成人(18-55岁,n = 180)在加拿大魁北克的两个地点随机接受两次肌肉注射CoVLP(3.75μg、7.5μg和15μg),间隔21天,单独注射或用AS03或CpG1018佐剂。结果显示,所有配方的耐受性都很好,接种后的不良事件通常是轻度到中度的,并且是短暂的,在佐剂组中最高。

CoVLP剂量对血清NAbs没有影响,但两种佐剂的滴度都明显增加。第二剂后,CoVLP+AS03组的NAbs比新冠患者康复期血清的滴度高10倍以上。此外,穗蛋白特异性干扰素-γ和白细胞介素-4的细胞反应也都被诱导

综上所述,这项预先指定的中期分析支持对CoVLP候选疫苗的进一步评估。

 

原始出处:

Brian J. Ward et al. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nature Medicine (2021). 

 

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    2021-05-22 liye789132251
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    2022-02-01 xuyong535
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    2021-06-13 荔枝啊

    学习了

    0

  4. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sat May 22 17:31:39 CST 2021, time=2021-05-22, status=1, ipAttribution=)]
    2021-05-31 SR~young海东

    战胜疫情,刻不容缓!

    0

  5. 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  6. 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  7. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sat May 22 17:31:39 CST 2021, time=2021-05-22, status=1, ipAttribution=)]
    2021-05-23 医鸣惊人

    认真学习了

    0

  8. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Mon May 24 06:41:16 CST 2021, time=2021-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=967944, encodeId=7f0296e94427, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Sun May 23 16:51:15 CST 2021, time=2021-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029518, encodeId=5fb1102951854, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Sat May 22 18:41:16 CST 2021, time=2021-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039024, encodeId=708a103902454, content=高质量研究,读起来真爽,谢谢梅斯, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Sat May 22 18:41:16 CST 2021, time=2021-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=967782, encodeId=4cb896e782c5, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sat May 22 17:31:39 CST 2021, time=2021-05-22, status=1, ipAttribution=)]
    2021-05-22 公卫新人

    新冠肺炎,疫情何时才能消失

    0

  9. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Mon May 24 06:41:16 CST 2021, time=2021-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=967944, encodeId=7f0296e94427, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Sun May 23 16:51:15 CST 2021, time=2021-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029518, encodeId=5fb1102951854, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Sat May 22 18:41:16 CST 2021, time=2021-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039024, encodeId=708a103902454, content=高质量研究,读起来真爽,谢谢梅斯, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Sat May 22 18:41:16 CST 2021, time=2021-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=967782, encodeId=4cb896e782c5, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sat May 22 17:31:39 CST 2021, time=2021-05-22, status=1, ipAttribution=)]
    2021-05-22 肿瘤克星

    高质量研究,读起来真爽,谢谢梅斯

    0

  10. 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encodeId=5fb1102951854, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Sat May 22 18:41:16 CST 2021, time=2021-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039024, encodeId=708a103902454, content=高质量研究,读起来真爽,谢谢梅斯, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Sat May 22 18:41:16 CST 2021, time=2021-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=967782, encodeId=4cb896e782c5, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sat May 22 17:31:39 CST 2021, time=2021-05-22, status=1, ipAttribution=)]
    2021-05-22 jyzxjiangqin

    好文章!

    0

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