JAMA Netw Open:经过临床试验验证的疫苗就能适用于所有人吗?

2021-02-22 MedSci原创 MedSci原创

经过临床试验验证的疫苗就能适用于所有人吗?

疫苗是上世纪最重要的公共卫生发展之一,大大降低了全球范围内主要传染病的发病率和死亡率,尤其是在新冠病毒肆虐的2020年,几乎全世界的人都切身感受到了疫苗的重要性。

众所周知,疫苗从研发到临床应用是必须经过临床试验验证疫苗的有效性和安全性。然而,医学研究并没有公平地纳入不同种族/少数民族成员或女性和老年人。疫苗试验中关于参与者人口统计特征的数据有限,尽管这些数据对目前旨在预防新冠病毒的试验很重要。

Flores等人开展了一项横断面研究,分析了从2011年7月1日到2020年6月30日在ClinicalTrials.gov上注册的已完成的美国疫苗试验的数据,旨在调查疫苗临床试验参与者中少数族裔群体、女性和老年人的代表性是否合理。

研究流程

主要结果和衡量标准:与2011年和2018年美国人口普查数据相比,种族/少数民族、女性和老年人的数量和百分比。次要结果指标包括试验阶段和完成年份。

报告种族/民族的试验统计情况

本分析纳入了230项临床试验共219 555名参与者。大多数试验是随机试验(180项[78.3%]),包括病毒疫苗接种(159项[69.1%]),涵盖所有试验阶段。每项试验都报告了受试者的年龄和性别;134项(58.3%)报告了种族,79项(34.3%)报告了民族。

总体而言,与美国人口普查数据相比,在成年参与者中,白人占比过多(77.9%;95%CI 77.4%-78.4%),黑人或非洲裔美国人(10.6%;10.2%-11.0%)和美国印第安人或阿拉斯加原住民(0.4%;0.3%-0.5%)代表不足;亚洲人的入组人数相似(5.7%;5.5%-6.0%)。西班牙裔或拉丁裔个人的登记人数(11.6%;11.1%-12.0%)也很低。

不同试验的人口统计学特征

成人试验由更多的女性参与者组成(75?325[56.0%]),但在那些报告年龄组成的试验中,65岁或65岁以上的参与者的登记人数较低(12.1%;12.0%-12.3%)。在儿科试验中,黑人或非洲裔美国人参与者(10.1%;9.7%-10.6%)和西班牙裔或拉丁裔参与者(22.5%;21.6%-23.4%)也未得到充分代表。

在报告种族/民族的试验中,65项(48.5%)试验未纳入美国印第安人或阿拉斯加原住民参与者,81项(60.4%)未纳入夏威夷人或太平洋岛民参与者。

综上,这项横断面研究发现,在以美国为基础的疫苗临床试验中,种族/少数民族群体成员和老年人的代表性不足,而女性成年人的代表性过高。这些发现表明,所有针对流行病学重要感染的疫苗试验都应包括多样性登记目标。该结果对以后的疫苗试验,包括新冠病毒疫苗试验,都具有很重要的提示作用。

原始出处:

Flores Laura E,Frontera Walter R,Andrasik Michele P et al. Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials. JAMA Netw Open, 2021, 4: e2037640.

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    2021-07-23 canlab
  2. [GetPortalCommentsPageByObjectIdResponse(id=1734320, encodeId=e52f1e343208d, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ea033781210, createdName=canlab, createdTime=Fri Jul 23 16:42:41 CST 2021, time=2021-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728835, encodeId=0bf01e2883581, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Mon Mar 22 18:42:41 CST 2021, time=2021-03-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=945288, encodeId=129394528801, content=肯定不行啊<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, 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/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Wed Mar 03 22:47:25 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036469, encodeId=a7fb1036469b5, content=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, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Feb 22 18:42:41 CST 2021, time=2021-02-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926417, encodeId=088392641ec8, content=这项横断面研究发现,在以美国为基础的疫苗临床试验中,种族/少数民族群体成员和老年人的代表性不足,而女性成年人的代表性过高。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Mon Feb 22 17:23:45 CST 2021, time=2021-02-22, status=1, ipAttribution=)]
    2021-03-22 feather89
  3. [GetPortalCommentsPageByObjectIdResponse(id=1734320, encodeId=e52f1e343208d, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ea033781210, createdName=canlab, createdTime=Fri Jul 23 16:42:41 CST 2021, time=2021-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728835, encodeId=0bf01e2883581, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Mon Mar 22 18:42:41 CST 2021, time=2021-03-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=945288, encodeId=129394528801, content=肯定不行啊<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, 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/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Wed Mar 03 22:47:25 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036469, encodeId=a7fb1036469b5, content=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, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Feb 22 18:42:41 CST 2021, time=2021-02-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926417, encodeId=088392641ec8, content=这项横断面研究发现,在以美国为基础的疫苗临床试验中,种族/少数民族群体成员和老年人的代表性不足,而女性成年人的代表性过高。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Mon Feb 22 17:23:45 CST 2021, time=2021-02-22, status=1, ipAttribution=)]
    2021-03-03 liyu7822

    肯定不行啊#新冠肺炎#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1734320, encodeId=e52f1e343208d, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ea033781210, createdName=canlab, createdTime=Fri Jul 23 16:42:41 CST 2021, time=2021-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728835, encodeId=0bf01e2883581, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Mon Mar 22 18:42:41 CST 2021, time=2021-03-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=945288, encodeId=129394528801, content=肯定不行啊<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, 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/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Wed Mar 03 22:47:25 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036469, encodeId=a7fb1036469b5, content=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, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Feb 22 18:42:41 CST 2021, time=2021-02-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926417, encodeId=088392641ec8, content=这项横断面研究发现,在以美国为基础的疫苗临床试验中,种族/少数民族群体成员和老年人的代表性不足,而女性成年人的代表性过高。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Mon Feb 22 17:23:45 CST 2021, time=2021-02-22, status=1, ipAttribution=)]
    2021-02-22 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

  5. [GetPortalCommentsPageByObjectIdResponse(id=1734320, encodeId=e52f1e343208d, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ea033781210, createdName=canlab, createdTime=Fri Jul 23 16:42:41 CST 2021, time=2021-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728835, encodeId=0bf01e2883581, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Mon Mar 22 18:42:41 CST 2021, time=2021-03-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=945288, encodeId=129394528801, content=肯定不行啊<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, 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/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Wed Mar 03 22:47:25 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036469, encodeId=a7fb1036469b5, content=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, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Feb 22 18:42:41 CST 2021, time=2021-02-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926417, encodeId=088392641ec8, content=这项横断面研究发现,在以美国为基础的疫苗临床试验中,种族/少数民族群体成员和老年人的代表性不足,而女性成年人的代表性过高。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Mon Feb 22 17:23:45 CST 2021, time=2021-02-22, status=1, ipAttribution=)]
    2021-02-22 随梦飞扬

    这项横断面研究发现,在以美国为基础的疫苗临床试验中,种族/少数民族群体成员和老年人的代表性不足,而女性成年人的代表性过高。

    0

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