Nat Med:CoronaVac灭活疫苗在自身免疫性风湿病患者中的免疫原性和安全性:4期临床试验 

2021-08-01 haibei MedSci原创

目前,CoronaVac在免疫力低下的个体中的免疫原性还没有得到很好的证实。为此,研究人员启动了一项前瞻性的4期对照试验(编号:NCT04754698,CoronavRheum)。

至今为止,新冠病毒已经在全世界感染了数百万人。其中,巴西是SARS-CoV-2确诊病例和死亡人数最多的国家之一,截至2021年5月,登记的死亡人数超过43万,感染患者大约有1500万例。

第二次感染浪潮是由伽马冠状病毒变体推动的,该变体被认为比原始毒株的传染性强2.5倍,并且可能与60岁以下患者住院和进入重症监护室的风险较高有关。2021年3月和4月的第二次高峰导致感染新冠的报告病例是2020年第一次高峰的两倍以上。因此,在降低COVID-19死亡率和发病率方面,疫苗是至关重要的。

CoronaVac,一种针对SARS-CoV-2的灭活病毒疫苗,已在多个国家获得世界卫生组织(WHO)的紧急使用批准,包括世界上六个人口最多的国家中的三个--巴西、中国和土耳其,这对全球控制这种疾病很重要。其在中国、香港、印度尼西亚、巴西、智利、菲律宾和土耳其的3期临床试验结果仍在巩固中。

目前,CoronaVac已占到巴西所注射疫苗的75%左右。它可以冷藏保存,这对于在发展中国家部署是一个巨大的优势。此外,与其他只使用刺突蛋白的疫苗平台相比,使用整个病毒的传统技术可能会带来更广泛的免疫反应。这可能与控制SARS-CoV-2变体有关,这些变体含有刺突蛋白的突变。在巴西进行的一项3期临床试验中,使用CoronaVac接种的健康志愿者对Gamma和Zeta变体表现出了交叉反应的体液免疫反应。

目前,CoronaVac在免疫力低下的个体中的免疫原性还没有得到很好的证实。为此,研究人员启动了一项前瞻性的4期对照试验(编号:NCT04754698,CoronavRheum),该试验包括了910名患有自身免疫性风湿病(ARD)的成年人和182名年龄和性别频率匹配的健康成年人(对照组,CG),他们都接受了两剂CoronaVac。

该临床试验的主要结果为,与CG组相比,ARD组在第二剂后6周(第69天(D69))抗SARS-CoV-2 IgG血清转换(SC)和中和抗体(NAb)阳性率均下降≥15%。次要结果是D28的IgG SC和NAb阳性率,D28和D69的IgG滴度和中和活性,以及疫苗的安全性。

ARD患者和CG受试者在D0、D28和D69的抗SARS-CoV-2 S1/S2 IgG滴度

结果显示,预先指定的终点已经达到,ARD组在D69的抗SARS-Cov-2 IgG SC(70.4%对95.5%,P<0.001)和NAb阳性率(56.3%对79.3%,P<0.001)均低于CG。此外,ARD患者的IgG滴度(12.1对29.7,P<0.001)和中和活性(58.7对64.5%,P=0.013)在D69时也较低

在D28时,ARD患者的IgG频率(18.7对34.6%,P<0.001)和NAb阳性率(20.6对36.3%,P<0.001)低于CG。此外,该研究中没有中度/重度不良事件。

总之,这些数据支持CoronaVac在ARD患者中的应用,表明其短期免疫原性有所降低但可以接受。目前,该试验仍在进行中,以评估其长期有效性/免疫原性。

 

原始出处:

Ana C. Medeiros-Ribeiro et al. Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial. Nature Medicine (2021). 

 

 

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  5. [GetPortalCommentsPageByObjectIdResponse(id=2078865, encodeId=331120e8865d0, 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=33, 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=Mon Oct 04 22:22:27 CST 2021, time=2021-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1885341, encodeId=b0621885341c7, content=<a href='/topic/show?id=3b2112532d8' target=_blank style='color:#2F92EE;'>#Nat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12532, encryptionId=3b2112532d8, topicName=Nat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e6f107, createdName=liye789132251, createdTime=Sun Sep 12 13:22:27 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393829, encodeId=430c1393829a1, 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=41, 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=Tue Aug 03 05:22:27 CST 2021, time=2021-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1611193, encodeId=626316111937d, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, 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=Tue Aug 03 05:22:27 CST 2021, time=2021-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1004447, encodeId=3239100444e86, content=#【支气管镜技术3天训练营】开班啦!浙江省肿瘤医院李亚清教授邀您报名# , beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210511/ddebdec707734c8390a07bd0c1048717/cc11caf5d607430e9f4ca556fed68ab1.jpg, createdBy=2c4d5497888, createdName=梅斯小助手M, createdTime=Sun Aug 01 19:01:52 CST 2021, time=2021-08-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1004440, encodeId=5fc61004440b3, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=224b1515040, createdName=yxh20210801, createdTime=Sun Aug 01 17:51:56 CST 2021, time=2021-08-01, status=1, ipAttribution=)]
    2021-08-01 梅斯小助手M

    #【支气管镜技术3天训练营】开班啦!浙江省肿瘤医院李亚清教授邀您报名#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=2078865, encodeId=331120e8865d0, 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=33, 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=Mon Oct 04 22:22:27 CST 2021, time=2021-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1885341, encodeId=b0621885341c7, content=<a href='/topic/show?id=3b2112532d8' target=_blank style='color:#2F92EE;'>#Nat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12532, encryptionId=3b2112532d8, topicName=Nat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e6f107, createdName=liye789132251, createdTime=Sun Sep 12 13:22:27 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393829, encodeId=430c1393829a1, 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=41, 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=Tue Aug 03 05:22:27 CST 2021, time=2021-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1611193, encodeId=626316111937d, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, 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=Tue Aug 03 05:22:27 CST 2021, time=2021-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1004447, encodeId=3239100444e86, content=#【支气管镜技术3天训练营】开班啦!浙江省肿瘤医院李亚清教授邀您报名# , beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210511/ddebdec707734c8390a07bd0c1048717/cc11caf5d607430e9f4ca556fed68ab1.jpg, createdBy=2c4d5497888, createdName=梅斯小助手M, createdTime=Sun Aug 01 19:01:52 CST 2021, time=2021-08-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1004440, encodeId=5fc61004440b3, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=224b1515040, createdName=yxh20210801, createdTime=Sun Aug 01 17:51:56 CST 2021, time=2021-08-01, status=1, ipAttribution=)]
    2021-08-01 yxh20210801

    很好

    0

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