Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults
Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults
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DOI：
10.1056/nejmoa1501184
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发表时间：
2015-05-28
影响因子：
158.5
通讯作者：
Heineman, Thomas C.
中科院分区：
文献类型：
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作者：
Lal, Himal;Cunningham, Anthony L.;Heineman, Thomas C.
在先前涉及老年人的1-2期临床试验中，含有水痘-带状疱疹病毒糖蛋白E和AS01(B)佐剂系统（称为HZ/su）的亚单位疫苗具有临床可接受的安全性，并引发了强大的免疫反应。方法：我们在18个国家进行了一项随机、安慰剂对照的3期研究，以评估HZ/su在老年人（>= 50岁）中的有效性和安全性，根据年龄组（50 ~ 59岁，60 ~ 69岁，>= 70岁）进行分层。参与者间隔2个月接受两次肌肉注射疫苗或安慰剂。主要目的是评估该疫苗与安慰剂相比在降低老年人带状疱疹风险方面的功效。结果共有15411名可评估的参与者接受了疫苗（7698名）或安慰剂（7713名）。在平均3.2年的随访期间，在改良疫苗接种队列中，疫苗组中有6名参与者确诊带状疱疹，安慰剂组中有210名参与者确诊带状疱疹（发病率，0.3 vs. 9.1 / 1000人年）。疫苗对带状疱疹的总有效率为97.2%(95%可信区间[CI]， 93.7 ~ 99.0
BackgroundIn previous phase 1-2 clinical trials involving older adults, a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01(B) adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response.MethodsWe conducted a randomized, placebo-controlled, phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults (>= 50 years of age), stratified according to age group (50 to 59, 60 to 69, and >= 70 years). Participants received two intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to assess the efficacy of the vaccine, as compared with placebo, in reducing the risk of herpes zoster in older adults.ResultsA total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants). During a mean follow-up of 3.2 years, herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 vs. 9.1 per 1000 person-years) in the modified vaccinated cohort. Overall vaccine efficacy against herpes zoster was 97.2% (95% confidence interval [CI], 93.7 to 99.0; P