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Lancet:4价登革热疫苗TAK-003II期临床效果显著

2020-03-18 MedSci原创 MedSci原创

TAK-003疫苗对所有四种登革热血清型都产生了抗体反应,效果不依赖基线血清状况

具有普遍适用性的四价登革热疫苗仍是一个重大挑战,近日研究人员评估了三种不同剂量组合的四价登革热疫苗(tak-003)在48个月内对生活在登革热流行国家儿童的免疫原性和安全性。
 
本次研究为II期临床研究,在多米尼加共和国、巴拿马和菲律宾开展,年龄在2-17岁的健康参与者分别接受2剂量tak-003(第1天和第91天)、1剂量tak-003 (第1天)、1剂量tak-003加增效剂(第1天和第365天)或安慰剂。研究的主要目的是评估在每个方案第48个月各种血清型抗体的几何平均滴度。次要安全终点包括严重不良事件和症状病毒学证实的登革热参与者的比例。
 
1800名儿童参与研究,其中1剂量接种组201人,1剂量接种组398人,1剂量接种加增效剂组1002人,安慰剂组199人,1479名(82%)参与者完成了48个月的研究。在第48个月,与安慰剂组相比,所有TAK-003组的抗体滴度保持升高,与基线血清状态无关。在第48个月,DENV1亚型2剂量组的几何平均滴度为378,1剂量组为421,1剂量加增效剂组为719,安慰剂组为100。各组DENV2亚型几何平均滴度分别为:1052、1319、1200和208。DENV3亚型分别为: 183、201、288(和71。DENV4亚型分别为:152、164、219和46。四价血清阳性率分别为89%、86%、97%和60%。37名(2%)TAK-003组和13名(7%)安慰剂组参与者记录了经病毒学证实的登革热,相对风险为0.35。未报告与疫苗相关的严重不良事件或严重登革热病毒疾病。
 
研究认为,TAK-003疫苗对所有四种登革热血清型都产生了抗体反应,效果不依赖基线血清状况。
 
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    2021-01-05 howi
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    2020-03-18 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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