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LANCET INFECT DIS:尼泊尔儿童10价肺炎球菌偶联疫苗两种双剂量启动方案的比较:开放标签、随机非劣效对照试验

2019-02-02 MedSci MedSci原创

由于程序原因,尼泊尔婴儿接受10价肺炎球菌结合疫苗(PCV10)与起效剂量间隔1个月。因此,本研究目的是研究如果PCV10的第二次启动剂量间隔为1个月,而不是大家所反对的2个月,那么免疫应答对PCV10血清型是否是非劣反应。

在尼泊尔加德满都帕坦医院针对40-60天健康尼泊尔婴儿进行了一项开放标签,随机,平行组试验。如果孩子健康,出生时间超过或等于37周,居住在加德满都,并且除了BCG之外没有接种任何疫苗,并且口服脊髓灰质炎疫苗,则儿童有资格入选进入研究。参与者通过计算机生成的列表随机分配(11),该列表具有通过经过验证的基于Web的界面访问的随机变化的置换块大小,以在6周和10周龄时接收PCV106 + 10组)或者在6周龄和14周龄(6 + 14组),两组均在9个月时接受加强免疫。实验室工作人员对研究干预措施不清楚,通过ELISA分析血清样本中PCV10血清型抗体。主要结果是确定6 + 10时间节点是否不低于9个月时的6 + 14时间节点,基于血清型特异性IgG大于或等于0.35μg的婴儿比例/毫升。建立非劣效性为10%边缘值,主要终点是在经过修改的意向治疗人群中测量的,其中仅包括成功采集血样的参与者。该该试验在 ClinicalTrials.gov的编号 NCT02385513

研究发现,2015821日至201644日期间,304名尼泊尔儿童被随机分配到6 + 10组(n = 152)或6 + 14组(n = 152)。在9个月大的时候,血清型56 + 10时间表并不低(143 [79.25 ]143 vs 78 [53.4]146,差异为1.82[95CI -9.6~13.25]p = 0.021),血清型9V143 [66.46.1] 143 55 [37.6] 146,差异为8.48[-2.84~19.8]p = 0.001),血清型14110 [77.4%] vs 110 [74.8]147,差异为2.63[-7·27~12.54] p = 0.006),和血清型19F135 [95] 142 VS146 [146] 146,差异-4.92[-9.860]p = 0.022)。在同一时间点,血清型1未显示非劣效性(143例中为 36 [25·1]147 42 [28.5],差异为-3.39[95CI -13.566.77]p = 0·102),血清型4143 [70 [48.9]143 vs 87 [59.1]147,差异为-10.23[-21.64vs1.18 ]p = 0.516),血清型6B143 [67.1] 143 114 [77.5] 147,差异-10.41[-20.65-0·18] p = 0.532), 血清型7F99 [69.2] 143 vs 109 [74.1] 147,差异-4.91[-15·26~5·42]p = 0 .168),血清型18C89 [62.2]143 vs.147 [117·5] 147,差异-15.31[-25.78-4.83]p = 0.840),血清型23F37 [25.8] 143 41 147[27.8],差-2.01[-12.19~8.16]p = 0.062)。在加强剂量后,在10个月大时,当比较两种方案时,对于10种血清型中的任何一种,免疫原性(抗体大于或等于0.35μg/ mL的儿童的比例)均没有显着差异。32名参与者发生严重不良事件,6 + 10152名中有11名(7%),6+ 14组中152名中有21名(14%)。

研究表明,应尽可能实施6周,14周和9个月的时间表。然而,被认为能提高群体免疫力的增强后反应在这两种情况下是相似的。因此,6周、10周和9个月的计划可作为一种备选计划,病可以提供人群保护。

原始出处:

Rama Kandasamy, DPhilComparison of two schedules of two-dose priming with the ten-valent pneumococcal conjugate vaccine in Nepalese children: an open-label, randomised non-inferiority controlled trial

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    2019-09-18 howi
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  5. [GetPortalCommentsPageByObjectIdResponse(id=1829942, encodeId=4dab18299426e, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Wed Sep 18 13:51:00 CST 2019, time=2019-09-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1907931, encodeId=2f89190e9319e, content=<a href='/topic/show?id=b3c199328f2' target=_blank style='color:#2F92EE;'>#非劣效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99328, encryptionId=b3c199328f2, topicName=非劣效)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac1c235, createdName=tonychen21, createdTime=Sat Aug 10 16:51:00 CST 2019, time=2019-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2012936, encodeId=6ea220129363d, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, 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 Aug 17 01:51:00 CST 2019, time=2019-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1987239, encodeId=6d19198e23982, content=<a href='/topic/show?id=bac5466546c' target=_blank style='color:#2F92EE;'>#对照试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46654, encryptionId=bac5466546c, topicName=对照试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Sat Oct 19 20:51:00 CST 2019, time=2019-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1775447, encodeId=a3101e75447eb, content=<a href='/topic/show?id=937d46650bf' target=_blank style='color:#2F92EE;'>#对照#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Sun Oct 13 20:51:00 CST 2019, time=2019-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1485652, encodeId=5ca01485652fc, content=<a href='/topic/show?id=e1ec821e823' target=_blank style='color:#2F92EE;'>#肺炎球菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82178, encryptionId=e1ec821e823, topicName=肺炎球菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e328034144, createdName=ms24272190615788285182, createdTime=Mon Feb 04 00:51:00 CST 2019, time=2019-02-04, status=1, ipAttribution=)]
    2019-10-13 amyloid
  6. [GetPortalCommentsPageByObjectIdResponse(id=1829942, encodeId=4dab18299426e, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Wed Sep 18 13:51:00 CST 2019, time=2019-09-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1907931, encodeId=2f89190e9319e, content=<a href='/topic/show?id=b3c199328f2' target=_blank style='color:#2F92EE;'>#非劣效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99328, encryptionId=b3c199328f2, topicName=非劣效)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac1c235, createdName=tonychen21, createdTime=Sat Aug 10 16:51:00 CST 2019, time=2019-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2012936, encodeId=6ea220129363d, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, 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 Aug 17 01:51:00 CST 2019, time=2019-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1987239, encodeId=6d19198e23982, content=<a href='/topic/show?id=bac5466546c' target=_blank style='color:#2F92EE;'>#对照试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46654, encryptionId=bac5466546c, topicName=对照试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Sat Oct 19 20:51:00 CST 2019, time=2019-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1775447, encodeId=a3101e75447eb, content=<a href='/topic/show?id=937d46650bf' target=_blank style='color:#2F92EE;'>#对照#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Sun Oct 13 20:51:00 CST 2019, time=2019-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1485652, encodeId=5ca01485652fc, content=<a href='/topic/show?id=e1ec821e823' target=_blank style='color:#2F92EE;'>#肺炎球菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82178, encryptionId=e1ec821e823, topicName=肺炎球菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e328034144, createdName=ms24272190615788285182, createdTime=Mon Feb 04 00:51:00 CST 2019, time=2019-02-04, status=1, ipAttribution=)]
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