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JAMA:灭活全病毒Covid-19疫苗I-II期临床获得成功

2020-08-26 MedSci原创 MedSci原创

通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,可诱导健康志愿者产生免疫抗体

新冠肺炎疫苗是目前临床上最为紧迫的医疗资源,近日来自中国的研究人员评估了灭活全病毒Covid-19疫苗的安全性和免疫原性。
 
 
本次研究为I-II期临床研究,I期研究阶段招募96名参与者,接受3个剂量的疫苗(2.5, 5和10 μg/次)或安慰剂组,每组各24人,受试者在第0、28以及56天接受3次肌肉注射。II期研究阶段,224名成年志愿者接受5 μg/次疫苗,分为2组,第1组在第0和14天接受疫苗(n=84)或安慰剂(n=28),第2组在第0和21天接受疫苗(n=84)或安慰剂(n=28)。研究的主要安全终点为注射后7天的不良事件,疗效终点为疫苗接种完成后14天内中和抗体响应。
 
参与者平均年龄42.8岁,女性占62.5%。I期研究阶段,在安慰剂组、低剂量疫苗组、中等剂量疫苗组以及高剂量疫苗组,7天内不良事件分别发生3例(12.5%), 5例 (20.8%), 4 例(16.7%)和6例 (25.0%)。II期研究阶段,第1组参与者在接受疫苗后,安慰剂组4人(14.3%)和疫苗组5人(6.0%)出现不良事件,第2组参与者在接受疫苗后,安慰剂组5人(17.9%)和疫苗组16人(19.0%)出现不良事件。最常见的不良事件包括注射部位疼痛,其次是发热,多为轻度和自限性不良事件,未见严重不良反应。I期研究中,3剂量疫苗接种后,低至高剂量组,中和抗体的几何平均滴度分别为316、206和297,II期研究中,第1组接种完成后的中和抗体的几何平均滴度为121,第2组为247,安慰剂组未检测到中和抗体。
 
 
通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,可诱导健康志愿者产生免疫抗体。
 
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attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIpJVcpECMUAY5icrib4llUfqMibkadpib1nuViagH63VSvPdFoWDnU0kHNmmqlfzXsuHQwicAC2iaeUjjYA/132, createdBy=622b2355228, createdName=811688290, createdTime=Wed Aug 26 18:18:15 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813497, encodeId=4b8881349eb5, content=通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,希望疫苗快点安全的投入临床使用。<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=220, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70487, encryptionId=62afe048720, topicName=疫苗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Aug 26 18:09:27 CST 2020, time=2020-08-26, status=1, ipAttribution=)]
    2020-08-27 ms4000002082197205

    #新冠肺炎#早点出来

    0

  4. 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status=1, ipAttribution=)]
    2020-08-27 14818eb4m67暂无昵称

    学习了

    0

  5. 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attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIpJVcpECMUAY5icrib4llUfqMibkadpib1nuViagH63VSvPdFoWDnU0kHNmmqlfzXsuHQwicAC2iaeUjjYA/132, createdBy=622b2355228, createdName=811688290, createdTime=Wed Aug 26 18:18:15 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813497, encodeId=4b8881349eb5, content=通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,希望疫苗快点安全的投入临床使用。<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=220, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70487, encryptionId=62afe048720, topicName=疫苗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Aug 26 18:09:27 CST 2020, time=2020-08-26, status=1, ipAttribution=)]
    2020-08-27 ms7000000689223974

    相关资讯请继续分享,谢谢

    0

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createdAvatar=https://img.medsci.cn/20200823/ece0a24ea5824924b9ba0b87a5947f86/11f20d29045c49fd9671ef69fa0c4012.jpg, createdBy=f64a5412720, createdName=ms7000000689223974, createdTime=Thu Aug 27 10:03:08 CST 2020, time=2020-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813562, encodeId=98f8813562a9, content=<a href='/topic/show?id=d87e103834da' target=_blank style='color:#2F92EE;'>#灭活病毒疫苗#</a>的<a href='/topic/show?id=4dbd580630b' target=_blank style='color:#2F92EE;'>#新冠疫苗#</a>,还是很靠谱的,有效率应该在50%以上。但是<a href='/topic/show?id=343785e1771' target=_blank style='color:#2F92EE;'>#腺病毒#</a>相关<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>,可能难说,因为人类自身带了大量腺病毒相关抗体,疫苗进入体内后,自动会被清除掉的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=250, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103834, encryptionId=d87e103834da, topicName=灭活病毒疫苗), TopicDto(id=58063, encryptionId=4dbd580630b, 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attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIpJVcpECMUAY5icrib4llUfqMibkadpib1nuViagH63VSvPdFoWDnU0kHNmmqlfzXsuHQwicAC2iaeUjjYA/132, createdBy=622b2355228, createdName=811688290, createdTime=Wed Aug 26 18:18:15 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813497, encodeId=4b8881349eb5, content=通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,希望疫苗快点安全的投入临床使用。<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=220, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70487, encryptionId=62afe048720, topicName=疫苗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Aug 26 18:09:27 CST 2020, time=2020-08-26, status=1, ipAttribution=)]
    2020-08-27 ms7000000689223974

    很好很详细,谢谢分享

    0

  7. 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attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIpJVcpECMUAY5icrib4llUfqMibkadpib1nuViagH63VSvPdFoWDnU0kHNmmqlfzXsuHQwicAC2iaeUjjYA/132, createdBy=622b2355228, createdName=811688290, createdTime=Wed Aug 26 18:18:15 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813497, encodeId=4b8881349eb5, content=通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,希望疫苗快点安全的投入临床使用。<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=220, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70487, encryptionId=62afe048720, topicName=疫苗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Aug 26 18:09:27 CST 2020, time=2020-08-26, status=1, ipAttribution=)]
    2020-08-26 zhaojie88

    #灭活病毒疫苗##新冠疫苗#,还是很靠谱的,有效率应该在50%以上。但是#腺病毒#相关#疫苗#,可能难说,因为人类自身带了大量腺病毒相关抗体,疫苗进入体内后,自动会被清除掉的。

    0

  8. 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attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIpJVcpECMUAY5icrib4llUfqMibkadpib1nuViagH63VSvPdFoWDnU0kHNmmqlfzXsuHQwicAC2iaeUjjYA/132, createdBy=622b2355228, createdName=811688290, createdTime=Wed Aug 26 18:18:15 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813497, encodeId=4b8881349eb5, content=通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,希望疫苗快点安全的投入临床使用。<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=220, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70487, encryptionId=62afe048720, topicName=疫苗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Aug 26 18:09:27 CST 2020, time=2020-08-26, status=1, ipAttribution=)]
    2020-08-26 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

  9. 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createdAvatar=https://img.medsci.cn/20200823/ece0a24ea5824924b9ba0b87a5947f86/11f20d29045c49fd9671ef69fa0c4012.jpg, createdBy=f64a5412720, createdName=ms7000000689223974, createdTime=Thu Aug 27 10:03:08 CST 2020, time=2020-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813562, encodeId=98f8813562a9, content=<a href='/topic/show?id=d87e103834da' target=_blank style='color:#2F92EE;'>#灭活病毒疫苗#</a>的<a href='/topic/show?id=4dbd580630b' target=_blank style='color:#2F92EE;'>#新冠疫苗#</a>,还是很靠谱的,有效率应该在50%以上。但是<a href='/topic/show?id=343785e1771' target=_blank style='color:#2F92EE;'>#腺病毒#</a>相关<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>,可能难说,因为人类自身带了大量腺病毒相关抗体,疫苗进入体内后,自动会被清除掉的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=250, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103834, encryptionId=d87e103834da, topicName=灭活病毒疫苗), TopicDto(id=58063, encryptionId=4dbd580630b, 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attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIpJVcpECMUAY5icrib4llUfqMibkadpib1nuViagH63VSvPdFoWDnU0kHNmmqlfzXsuHQwicAC2iaeUjjYA/132, createdBy=622b2355228, createdName=811688290, createdTime=Wed Aug 26 18:18:15 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813497, encodeId=4b8881349eb5, content=通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,希望疫苗快点安全的投入临床使用。<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=220, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70487, encryptionId=62afe048720, topicName=疫苗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Aug 26 18:09:27 CST 2020, time=2020-08-26, status=1, ipAttribution=)]
    2020-08-26 811688290

    早些上市😳😳

    0

  10. 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attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIpJVcpECMUAY5icrib4llUfqMibkadpib1nuViagH63VSvPdFoWDnU0kHNmmqlfzXsuHQwicAC2iaeUjjYA/132, createdBy=622b2355228, createdName=811688290, createdTime=Wed Aug 26 18:18:15 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813497, encodeId=4b8881349eb5, content=通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,希望疫苗快点安全的投入临床使用。<a href='/topic/show?id=62afe048720' target=_blank style='color:#2F92EE;'>#疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=220, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70487, encryptionId=62afe048720, topicName=疫苗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Aug 26 18:09:27 CST 2020, time=2020-08-26, status=1, ipAttribution=)]
    2020-08-26 Jessica

    通过本次I-II期研究,灭活全病毒Covid-19疫苗是安全性的,希望疫苗快点安全的投入临床使用。#疫苗#

    0

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