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Lancet Infect Dis:SARS-CoV-2灭活疫苗BBIBP-CorV的安全性和免疫原性

2021-06-26 MedSci原创 MedSci原创

正在进行的COVID-19大流行需要加快对候选疫苗的测试工作。近日,在中国河南进行的一项随机、双盲、安慰剂对照试验评估了一种灭活的严重急性呼吸道综合征冠状病毒2(SARS-CoV-2)候选疫苗BBIB

正在进行的COVID-19大流行需要加快对候选疫苗的测试工作。近日,在中国河南进行的一项随机、双盲、安慰剂对照试验评估了一种灭活的严重急性呼吸道综合征冠状病毒2(SARS-CoV-2)候选疫苗BBIBP-CorV在人类中的安全性和免疫原性,结果已发表于Lancet Infect Dis。

在第一阶段,研究纳入18-80岁的健康人,在筛查时血清中SARS-CoV-2的特异性IgM/IgG抗体阴性者被分成两个年龄组(18-59岁和≥60岁),随机分配接受疫苗或安慰剂,在第0天和第28天分别注射2μg、4μg或8μg的两剂。在第二阶段,健康成人(18-59岁)被随机分配(1:1:1:1)在第0天接受8微克的单剂量疫苗或安慰剂,或在第0和14、0和21或0和28天接受4微克的双剂量疫苗。每个队列中的参与者通过分层区块随机分配(区块大小为8),并分配(3:1)接受疫苗或安慰剂。次要结果是免疫原性。

 

结果显示,在第一阶段,192名参与者(平均年龄53-7岁[SD 15-6])被随机分配接受疫苗(2μg[n=24],4μg[n=24],或8μg[n=24],两个年龄组[18-59岁和≥60岁])或安慰剂(n=24)。在144名疫苗接种者中,有42人(29%)在接种后的头7天内报告了至少一种不良反应。最常见的系统性不良反应是发热(18-59岁,2μg组1例[4%],4μg组1例[4%],8μg组2例[8%];≥60岁,8μg组1例[4%])。所有的不良反应都是轻度或中度的。疫苗接种后28天内没有严重不良事件的报告。在第42天,与安慰剂组相比(2.0 [2.0-2.0]),18-59岁组的中和抗体几何平均滴度较高(87.7 [95% CI 64.9-118.6],2μg组;211.2 [158.9-280.6],4μg组;和228.7[186.1-281.1],8μg组)和≥60岁组(80.7[65-4-99-6],2μg组;131.5[108.2-159.7],4μg组;和170.87[133-0-219-5],8μg组)。

 

在第2阶段,招募了448名参与者(平均年龄41.7岁[SD 9.9]),随机分配到接受疫苗(第0天8微克[n=84]或第0和14天4微克[n=84],第0和21天[n=84],或第0和28天[n=84])或安慰剂的相同时间表(n=112)。336名疫苗接种者中,有76人(23%)在头7天内报告了至少一种不良反应(33人[39%],8μg第0天;18人[21%],4μg第0和14天;15人[18%],4μg第0和21天;以及10人[12%],4μg第0和28天)。4μg第0天和21天组的一名安慰剂接受者报告了3级发烧,但已康复。所有其他不良反应都是轻度或中度的。最常见的系统性不良反应是发热(1例[1%],8μg第0天;1例[1%],4μg第0和14天;3例[4%],4μg第0和21天;2例[2%],4μg第0和28天)。在第28天,4μg第0和14天(169.5,95% CI 132-217.1)、第0和21天(282.7,221.2-361.4)以及第0和28天(218.0,181.8-261.3)的疫苗激发的中和抗体滴度明显高于8μg第0天的方案(14.7,11.6-18.8;所有P<0-001)。

综上,SARS-CoV-2灭活疫苗BBIBP-CorV在两个年龄组的所有测试剂量中都是安全的,且耐受性良好。所有疫苗接受者在第42天都能诱发针对SARS-CoV-2的体液反应。在第0天和21天或第0天和28天用4μg疫苗进行两剂免疫,比在第0天和14天用单剂8μg或4μg疫苗的中和抗体滴度更高。

 

原始出处:

 

Shengli Xia, Yuntao Zhang, et al., Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021 Jan;21(1):39-51. doi: 10.1016/S1473-3099(20)30831-8.  

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    2022-05-14 howi
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    2021-11-17 hukaixun
  4. [GetPortalCommentsPageByObjectIdResponse(id=2078861, encodeId=d37220e8861ba, content=<a href='/topic/show?id=f48865242bb' target=_blank style='color:#2F92EE;'>#活疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65242, encryptionId=f48865242bb, topicName=活疫苗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e4aa106, createdName=crystal0562, createdTime=Thu Apr 07 20:13:11 CST 2022, time=2022-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831224, encodeId=7a0d183122438, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sat May 14 15:13:11 CST 2022, time=2022-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1938020, encodeId=ba411938020bf, content=<a href='/topic/show?id=02de15902d3' target=_blank style='color:#2F92EE;'>#SARS-CoV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15902, encryptionId=02de15902d3, topicName=SARS-CoV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6ab940, createdName=hukaixun, createdTime=Wed Nov 17 18:13:11 CST 2021, time=2021-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2013643, encodeId=0dca201364337, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Sat Jan 29 04:13:11 CST 2022, time=2022-01-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1011829, encodeId=3cfb10118293b, content=加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210525/5199af023de64f5ab25409ed47b07b22/f2f79c9923e94162812670f2ca3fbe90.jpg, createdBy=0fb75484188, createdName=Leo201, createdTime=Thu Aug 26 21:37:11 CST 2021, time=2021-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1321287, encodeId=71d5132128e4a, content=<a href='/topic/show?id=ac0d159007f' target=_blank style='color:#2F92EE;'>#SARS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15900, encryptionId=ac0d159007f, topicName=SARS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8306486, createdName=小刀医生, createdTime=Mon Jun 28 14:13:11 CST 2021, time=2021-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393824, encodeId=e582139382412, content=<a href='/topic/show?id=718528982e3' target=_blank style='color:#2F92EE;'>#免疫原性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28982, encryptionId=718528982e3, topicName=免疫原性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/78FA0899509C358B01B975E8EAC1F88A/100, createdBy=7d822500145, createdName=ms5353107019656438, createdTime=Mon Jun 28 14:13:11 CST 2021, time=2021-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1034375, encodeId=b99c10343e5f2, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Sun Jun 27 02:13:11 CST 2021, time=2021-06-27, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=2078861, encodeId=d37220e8861ba, content=<a href='/topic/show?id=f48865242bb' target=_blank style='color:#2F92EE;'>#活疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65242, encryptionId=f48865242bb, topicName=活疫苗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e4aa106, createdName=crystal0562, createdTime=Thu Apr 07 20:13:11 CST 2022, time=2022-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831224, encodeId=7a0d183122438, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sat May 14 15:13:11 CST 2022, time=2022-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1938020, encodeId=ba411938020bf, content=<a href='/topic/show?id=02de15902d3' target=_blank style='color:#2F92EE;'>#SARS-CoV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15902, encryptionId=02de15902d3, topicName=SARS-CoV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6ab940, createdName=hukaixun, createdTime=Wed Nov 17 18:13:11 CST 2021, time=2021-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2013643, encodeId=0dca201364337, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Sat Jan 29 04:13:11 CST 2022, time=2022-01-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1011829, encodeId=3cfb10118293b, content=加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210525/5199af023de64f5ab25409ed47b07b22/f2f79c9923e94162812670f2ca3fbe90.jpg, createdBy=0fb75484188, createdName=Leo201, createdTime=Thu Aug 26 21:37:11 CST 2021, time=2021-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1321287, encodeId=71d5132128e4a, content=<a href='/topic/show?id=ac0d159007f' target=_blank style='color:#2F92EE;'>#SARS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15900, encryptionId=ac0d159007f, topicName=SARS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8306486, createdName=小刀医生, createdTime=Mon Jun 28 14:13:11 CST 2021, time=2021-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393824, encodeId=e582139382412, content=<a href='/topic/show?id=718528982e3' target=_blank style='color:#2F92EE;'>#免疫原性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28982, encryptionId=718528982e3, topicName=免疫原性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/78FA0899509C358B01B975E8EAC1F88A/100, createdBy=7d822500145, createdName=ms5353107019656438, createdTime=Mon Jun 28 14:13:11 CST 2021, time=2021-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1034375, encodeId=b99c10343e5f2, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Sun Jun 27 02:13:11 CST 2021, time=2021-06-27, status=1, ipAttribution=)]
    2021-08-26 Leo201

    加油

    0

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    2021-06-28 小刀医生
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    2021-06-27 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0

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