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从出生开始预防轮状病毒感染的人新生儿轮状病毒疫苗
Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth


Julie E. Bines ... 其他 • 2018.02.22
相关阅读
• 用新型轮状病毒疫苗进行新生儿免疫接种

摘要


背景

在出生时施用新生儿轮状病毒疫苗用于轮状病毒性胃肠炎早期预防,这一策略可能消除全球推行轮状病毒疫苗接种所面临的一些障碍。

 

方法

为了评估一种口服的人新生儿轮状病毒疫苗(RV3-BB)对预防轮状病毒性胃肠炎的效果,我们在印度尼西亚开展了一项设有安慰剂对照的随机双盲试验。健康新生儿接受了3剂RV3-BB或者安慰剂,施药按照新生儿程序(0~5日龄、8周龄和14周龄)或婴儿程序(8周龄、14周龄和18周龄)进行。对符合方案人群进行了主要分析,这一人群仅包括在访视窗口期内接受了所有4剂疫苗或安慰剂的参与者;对意向性治疗人群进行了次要分析,这一人群包括所有接受了随机化的参与者。

 

结果

在符合方案人群的1,513名参与者中,安慰剂组参与者在18月龄前出现重度轮状病毒性胃肠炎的比例为5.6%(504名婴儿中的28名),新生儿程序疫苗组中的这一比例为1.4%(498名中的7名),而婴儿程序疫苗组中的这一比例为2.7%(511名中的14名)。根据这一结果,新生儿程序组的疫苗效力为75%(95%置信区间[CI],44~91;P<0.001);婴儿程序组的疫苗效力为51%(95% CI,7~76;P=0.03);合并疫苗组(新生儿程序组和婴儿程序组合并)的疫苗效力为63%(95% CI,34~80;P<0.001)。在意向性治疗分析(1,649名参与者)中观察到了类似的结果:新生儿程序组的疫苗效力为68%(95% CI,35~86;P=0.001);婴儿程序组的疫苗效力为52%(95% CI,11~76;P=0.02);合并疫苗组的疫苗效力为60%(95% CI,31~76;P<0.001)。如果根据血清免疫应答或大便中的RV3-BB排毒证明产生了疫苗应答,则新生儿程序组的83名参与者中有78名产生疫苗应答(94%),婴儿程序组的84名参与者中有83名产生疫苗应答(99%)。组间的不良事件发生率相似。施用任何1剂疫苗或安慰剂后的21日风险期内均未发生肠套叠,在婴儿程序组中第3剂疫苗施用后114日发生1例肠套叠。

 

结论

在印度尼西亚按照新生儿程序或婴儿程序施用RV3-BB,结果显示RV3-BB对预防重度轮状病毒性胃肠炎有效(由比尔及梅琳达·盖茨基金会[Bill and Melinda Gates Foundation]等资助;Australian New Zealand Clinical Trials Registry注册号为ACTRN12612001282875)。





作者信息

Julie E. Bines, M.D., Jarir At Thobari, Ph.D., Cahya Dewi Satria, M.D., Amanda Handley, M.P.H., Emma Watts, B.Sci., Daniel Cowley, Ph.D., Hera Nirwati, M.D., Ph.D., James Ackland, B.Sci., Jane Standish, M.B., B.S., Frances Justice, B.Sci., Gabrielle Byars, M.Bio.Med.Sci., Katherine J. Lee, Ph.D., et al.
From the RV3 Rotavirus Vaccine Program, Murdoch Children’s Research Institute (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P., R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of Gastroenterology and Clinical Nutrition, Royal Children’s Hospital Melbourne (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and Preventive Medicine, Monash University, and the Department of Infection and Immunity, Monash Children’s Hospital, Clayton (J.P.B.), and Medicines Development for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne — all in Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) — all in Indonesia; and the Bill and Melinda Gates Foundation, Seattle (C.D.K.). Address reprint requests to Dr. Bines at the University of Melbourne, Level 2, Royal Children’s Hospital, 50 Flemington Rd., Parkville, 3052, VIC, Australia, or at jebines@unimelb.edu.au.

 

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