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强生新冠疫苗3期临床试验由于参与者出现不明疾病而暂停

2020-10-13 JACKZHAO MedSci原创

新冠疫苗JNJ-78436735由于参与者出现不明原因疾病而被暂停。

强生公司发表声明称,其研发的新冠疫苗JNJ-78436735由于参与者出现不明原因疾病而被暂停。

美国科技媒体STAT报道称,强生证实了强生公司研发的新冠疫苗的60000名患者临床试验暂停,外部研究人员的文件指出,已满足“暂停规则”,用于招募患者报名的在线系统已经关闭。强生公司回应说这是由于“研究参与者的原因不明疾病”。 该公司拒绝提供更多细节。

该公司在一份声明中说,我们必须尊重此参与者的隐私,我们也正在了解有关该参与者疾病的更多信息,在共享更多信息之前掌握所有事实非常重要。

强生公司强调所谓的不良事件是临床研究的预期内事件,还强调了研究暂停和临床搁置之间的区别,这是一项正式的监管措施,可持续更长的时间。疫苗研究目前尚未进行临床研究。 强生公司表示,尽管它通常向公众传达临床保留信息,但通常不会通知公众临床试验暂停。

数据安全监督委员会(DSMB)周一晚些时候审查了此案。强生表示,在这种情况下,“经历不良事件的参与者”是否接受研究治疗或安慰剂“并不总是立即可见”。

尽管临床试验暂停并不罕见,在某些情况下仅持续几天,但在新冠大流行背景下SARS-CoV-2疫苗的竞赛中引起了极大的关注。强生公司的实验性COVID-19疫苗JNJ-78436735的I / IIa期研究结果已经出炉,研究人员称单剂量JNJ-78436735具有良好的耐受性和高度免疫原性。据悉,JNJ-78436735由强生子公司杨森Janssen使用AdVac技术平台开发,该平台还用于开发在欧洲获批的埃博拉疫苗,以及寨卡病毒、呼吸道合胞病毒(RSV)和艾滋病病毒(HIV)等候选疫苗。迄今为止,杨森的AdVac®技术平台已在杨森的研究性疫苗计划中为超过100,000人接种了疫苗。

借助杨森的AdVac®技术,该疫苗(如果成功的话)估计将在发射时在-20°C保持稳定两年,在2-8°C保持至少三个月稳定。这使该候选疫苗与标准疫苗分销渠道兼容 并且不需要新的基础架构即可将其提供给需要它的人。

9月8日,阿斯利康(AstraZeneca)和牛津大学(Oxford University)正在开发另一种Covid-19疫苗的大型研究也一度暂停,原因是该患者怀疑在英国发生了不良反应。人们认为患者患有脊髓横纹肌炎。疫苗在英国暂停使用大约一周后才恢复研究,此后在其他国家也重新开始继续试验,然而,它在美国的试验目前仍处于保留状态。

强生公司于9月23日开始在其第三阶段研究中招募志愿者。研究人员计划在美国和其他国家招募60000名参与者。

值得注意的是,这是继阿斯利康之后第二个暂停新冠疫苗三期临床试验的药企,此前阿斯利康短暂叫停了试验,在巴西、印度等地之后相继恢复试验,但在美国仍然是暂停状态。详细:因志愿者出现疑似严重不良反应,阿斯利康暂停新冠疫苗三期临床试验

 

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  4. 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GetPortalCommentsPageByObjectIdResponse(id=891714, encodeId=8aed891e144d, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>疫苗安全性不得不防, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Oct 13 10:13:13 CST 2020, time=2020-10-13, status=1, ipAttribution=)]
    2020-10-13 rayms

    还能接种吗?#新冠肺炎#

    1

    展开1条回复
  5. 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    2020-10-13 Jessica

    要对疫苗抱有希望,也许像阿斯利康, 过一段时间就继续恢复临床实验了。对于疫苗,安全可靠性最重要。

    0

  6. 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style='color:#2F92EE;'>#新冠肺炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210607/9f00a0de660e4b36b77a9a5f7620d6bf/98c22b17ddf7446fa7b9a618fabcb9f7.jpg, createdBy=a8fb2299762, createdName=Psycho.Dr Du, createdTime=Tue Oct 13 10:25:58 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891717, encodeId=c008891e1782, content=好好学习,天天向上, beContent=null, objectType=article, channel=null, level=null, likeNumber=98, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4d901889741, createdName=ms7792044158831279, createdTime=Tue Oct 13 10:19:02 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891714, encodeId=8aed891e144d, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>疫苗安全性不得不防, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Oct 13 10:13:13 CST 2020, time=2020-10-13, status=1, ipAttribution=)]
    2020-10-13 公卫新人

    新冠肺炎,疫情何时才能消失

    0

  7. 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encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220301/6252e946e5ef413b86dc0f7d1f73b6db/9a7e8c88a38e487b8da4968a67bbd261.png, createdBy=b9f692910, createdName=rayms, createdTime=Tue Oct 13 10:26:26 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891881, encodeId=a11f89188178, content=要对疫苗抱有希望,也许像阿斯利康, 过一段时间就继续恢复临床实验了。对于疫苗,安全可靠性最重要。, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Tue Oct 13 22:08:24 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1028651, encodeId=933d102865127, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Tue Oct 13 13:05:43 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891753, encodeId=fa66891e53d9, content=真有什么问题的话就应该及时止损, beContent=null, objectType=article, channel=null, level=null, likeNumber=157, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201013/6ee6446652144b4c9b537f863cfadef9/8634b77c964748d789d58a4afdb080f9.jpg, createdBy=85b25106792, createdName=ms3045952462634027, createdTime=Tue Oct 13 11:42:15 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891719, encodeId=e7d9891e19e9, content=大公司做的试验还是谨慎靠谱的,暂停没关系,安全性第一<a href='/topic/show?id=46ce580e865' target=_blank 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GetPortalCommentsPageByObjectIdResponse(id=891714, encodeId=8aed891e144d, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>疫苗安全性不得不防, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Oct 13 10:13:13 CST 2020, time=2020-10-13, status=1, ipAttribution=)]
    2020-10-13 ms3045952462634027

    真有什么问题的话就应该及时止损

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1911258, encodeId=b3cd191125854, content=<a href='/topic/show?id=18171289d6' target=_blank style='color:#2F92EE;'>#3期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1289, encryptionId=18171289d6, topicName=3期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d275294, createdName=andy2087, createdTime=Sat Dec 12 03:05:43 CST 2020, time=2020-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271742, encodeId=d10312e17424b, content=<a href='/topic/show?id=2c6c501e578' target=_blank style='color:#2F92EE;'>#强生#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50175, encryptionId=2c6c501e578, topicName=强生)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=de89102, 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GetPortalCommentsPageByObjectIdResponse(id=891714, encodeId=8aed891e144d, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>疫苗安全性不得不防, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Oct 13 10:13:13 CST 2020, time=2020-10-13, status=1, ipAttribution=)]
    2020-10-13 Psycho.Dr Du

    大公司做的试验还是谨慎靠谱的,暂停没关系,安全性第一#新冠肺炎#

    0

  9. 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GetPortalCommentsPageByObjectIdResponse(id=891714, encodeId=8aed891e144d, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>疫苗安全性不得不防, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Oct 13 10:13:13 CST 2020, time=2020-10-13, status=1, ipAttribution=)]
    2020-10-13 ms7792044158831279

    好好学习,天天向上

    0

  10. 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style='color:#2F92EE;'>#新冠肺炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210607/9f00a0de660e4b36b77a9a5f7620d6bf/98c22b17ddf7446fa7b9a618fabcb9f7.jpg, createdBy=a8fb2299762, createdName=Psycho.Dr Du, createdTime=Tue Oct 13 10:25:58 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891717, encodeId=c008891e1782, content=好好学习,天天向上, beContent=null, objectType=article, channel=null, level=null, likeNumber=98, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4d901889741, createdName=ms7792044158831279, createdTime=Tue Oct 13 10:19:02 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891714, encodeId=8aed891e144d, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>疫苗安全性不得不防, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Oct 13 10:13:13 CST 2020, time=2020-10-13, status=1, ipAttribution=)]
    2020-10-13 神盾医疗局局长Jack

    #新冠肺炎#疫苗安全性不得不防

    0

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