Lancet Infect Dis:脊髓灰质炎疫苗减少剂量后效果和安全性是否受影响?

2017-07-27 顾歆纯 环球医学资讯

全球根除脊髓灰质炎倡议(the Global Polio Eradication Initiative)的一个主要组成部分是扩大灭活疫苗的使用,特别是在缺少资源的国家,寻找口服脊髓灰质炎疫苗的替代成为重中之重。2017年7月,发表在《Lancet Infect Dis》的一项由多米尼加共和国、丹麦和美国科学家共同进行的研究,考察了同标准灭活脊髓灰质炎疫苗(IPV)相比,通过氢氧化铝(AI)吸附减少

全球根除脊髓灰质炎倡议(the Global Polio Eradication Initiative)的一个主要组成部分是扩大灭活疫苗的使用,特别是在缺少资源的国家,寻找口服脊髓灰质炎疫苗的替代成为重中之重。2017年7月,发表在《Lancet Infect Dis》的一项由多米尼加共和国、丹麦和美国科学家共同进行的研究,考察了同标准灭活脊髓灰质炎疫苗(IPV)相比,通过氢氧化铝(AI)吸附减少剂量的IPV的免疫原性和安全性。

背景:成本和供应限制是IPV使用面临的重要挑战。通过AI吸附来减少剂量是一个有前景的选择,并且在目标人群中确立其有效性是发展IPV-Al的一个重要里程碑。本临床研究的目的是表明3种IPV-Al疫苗与标准IPV相比的非劣效性。

方法:在多米尼加共和国进行的2期、非劣效性、观察者设盲、随机、对照、单中心试验中,之前未接受脊髓灰质炎疫苗的6周大的健康婴儿,按计算机生成随机分配到4组,接受4种配方中的一种(3倍减少剂量[1/3 IPV-Al]、5倍减少剂量[1/5 IPV-Al]、10倍减少剂量[1/10 IPV-Al]或IPV),在6周、10周和14周大时肌内注射。首要结局是1型、2型和3型脊髓灰质炎病毒的血清转化,其滴定度≥4倍母体抗体滴度且3次接种疫苗后≥8倍母体抗体滴度。如果IPV-Al和IPV之间血清转化率的90%置信区间(CI)双侧较低处差距超过?10%,则得出非劣效性的结论。安全分析基于安全分析集合(接受至少一次试验疫苗的随机分配的参与者),免疫原性分析基于符合方案人群。本研究在ClinicalTrials.gov注册,编号:NCT02347423。

结果:2015年2月2日~2015年9月26日,研究人员招募了824名婴儿。符合方案人群纳入820名婴儿;205名被随机分配到1/3 IPV-Al、205名接受1/5 IPV-Al、204名接受1/10 IPV-Al,206名接受IPV。两次疫苗接种后,3种IPV-Al疫苗的1型、2型和3型脊髓灰质炎病毒的血清转换到达主要终点的比例已经很高,但三次疫苗接种后更高(例如完成了免疫接种计划的扩大方案):1/3 IPV-Al:98.5%(n=202,1型)、97.6%((n=200,2型)和99.5%(n=204,3型);1/5 IPV-Al:99.5%(n=204,1型)、96.1%(n=197,2型)和98.5%(n=202,3型);1/10 IPV-Al:98.5%(n=201,1型)、94.6%(n=193,2型)和99.5%(n=203,3型)。所有三种IPV-Al不劣于IPV,每种脊髓灰质炎病毒血清转化百分比的绝对差异大于?10%(1/3 IPV-Al:1型-1.46[-3.60~0.10]、2型?0.98[-3.62~1.49]和3型-0.49[-2.16~0.86];1/5 IPV-Al:1型-0.49[-2.16~0.86]、2型?2.45[-5.47~0.27]和3型-1.46[-3.60~0.10];1/10 IPV-Al:1型-1.47[-3.62~0.10]、2型?3.94[-7.28~0.97]和3型0.49[-2.17~0.86])。发生与疫苗无关的3例严重的不良事件。

解释:疫苗的最低剂量(1/10 IPV-Al)在两到三次注射后均表现良好。基于这些结果,这种新疫苗正在3期试验考察阶段。

资助:Bill & Melinda Gates基金会。

专家点评:降低剂量疫苗能够解决贫困国家由于资源匮乏导致的儿童不能普遍接受疫苗免疫。

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