NEJM:M72/AS01E结核疫苗的有效性研究

2018-10-30 zhangfan MedSci原创

研究认为,M72/AS01E疫苗对潜伏性结核感染者的活动性肺结核病的预防率为54.0%并且具有良好的安全性

疫苗是目前阻断结核病传播的有效手段,近日研究人员在非洲地区开展IIb研究,考察M72/AS01E结核疫苗对HIV阴性的潜伏性结核感染人群的疗效。

18-50岁感染者参与研究,间隔1个月接受2剂量肌内M72/AS01E疫苗或安慰剂,研究考察M72/AS01E的安全性及其对经细菌证实的活动性肺结核病进展的预防效果。临床肺结核疑似患者通过痰聚合酶链反应试验或分枝杆菌培养确诊。

研究随访2.3年,其中1786人接种疫苗,1787人接种安慰剂。疫苗组10名患者发生活动性结核感染,安慰剂组22人,每100随访年活动性结核发病0.3 vs 0.6例。疫苗的有效率为54.0%。注射后30天,疫苗组不良事件率为67.4%,安慰剂组为45.5%,主要是注射部位反应和流感样症状。组间严重不良事件,潜在免疫介导性疾病和死亡率相近。

研究认为,M72/AS01E疫苗对潜伏性结核感染者的活动性肺结核病的预防率为54.0%并且具有良好的安全性。.

原始出处:

Olivier Van Der Meeren et al. Phase 2b Controlled Trial of M72/AS01E Vaccine to Prevent Tuberculosis.N Engl J Med, October 25, 2018.

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1634182, encodeId=edd316341820d, content=<a href='/topic/show?id=020b111961d' target=_blank style='color:#2F92EE;'>#M72/AS01E#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11196, encryptionId=020b111961d, topicName=M72/AS01E)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3fa922077998, createdName=bbwuyu_010, createdTime=Thu Mar 14 05:54:00 CST 2019, time=2019-03-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=351488, encodeId=0949351488d4, content=还需进一步临床验证, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170701/IMG595791009FB761316.jpg, createdBy=abd01695121, createdName=吴教授, createdTime=Sun Nov 04 09:32:20 CST 2018, time=2018-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1254231, encodeId=3387125423100, content=<a href='/topic/show?id=f30ae86297d' target=_blank style='color:#2F92EE;'>#结核#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78629, encryptionId=f30ae86297d, topicName=结核)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=huhuaidong387, createdTime=Thu Nov 01 00:54:00 CST 2018, time=2018-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=350943, encodeId=71063509437a, content=好文,值得点赞!认真学习了,把经验应用于实践,为患者解除病痛。, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30251637888, createdName=lietome15, createdTime=Tue Oct 30 10:04:34 CST 2018, time=2018-10-30, status=1, ipAttribution=)]
    2018-11-04 吴教授

    还需进一步临床验证

    0

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  4. [GetPortalCommentsPageByObjectIdResponse(id=1634182, encodeId=edd316341820d, content=<a href='/topic/show?id=020b111961d' target=_blank style='color:#2F92EE;'>#M72/AS01E#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11196, encryptionId=020b111961d, topicName=M72/AS01E)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3fa922077998, createdName=bbwuyu_010, createdTime=Thu Mar 14 05:54:00 CST 2019, time=2019-03-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=351488, encodeId=0949351488d4, content=还需进一步临床验证, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170701/IMG595791009FB761316.jpg, createdBy=abd01695121, createdName=吴教授, createdTime=Sun Nov 04 09:32:20 CST 2018, time=2018-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1254231, encodeId=3387125423100, content=<a href='/topic/show?id=f30ae86297d' target=_blank style='color:#2F92EE;'>#结核#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78629, encryptionId=f30ae86297d, topicName=结核)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=huhuaidong387, createdTime=Thu Nov 01 00:54:00 CST 2018, time=2018-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=350943, encodeId=71063509437a, content=好文,值得点赞!认真学习了,把经验应用于实践,为患者解除病痛。, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30251637888, createdName=lietome15, createdTime=Tue Oct 30 10:04:34 CST 2018, time=2018-10-30, status=1, ipAttribution=)]
    2018-10-30 lietome15

    好文,值得点赞!认真学习了,把经验应用于实践,为患者解除病痛。

    0

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NEJM:M72/AS01E疫苗可有效预防潜伏性肺结核感染

研究认为M72/AS01E对潜伏性结核感染的预防有效率为54%