Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults
Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults
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DOI：
10.1056/nejmoa1315727
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发表时间：
2014-08-14
影响因子：
158.5
通讯作者：
Talbot, H. Keipp
中科院分区：
文献类型：
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作者：
DiazGranados, Carlos A.;Dunning, Andrew J.;Talbot, H. Keipp
背景：与标准剂量疫苗相比，高剂量三价灭活流感疫苗（IIV3-HD）可改善65岁及以上成年人对流感的抗体反应。这项研究评估了IIV3-HD是否也能提高对实验室确认的流感疾病的保护。方法我们开展了一项IIIb-IV期、多中心、随机、双盲、主动对照试验，比较IIV3-HD（每株血凝素60 μ g）和标准剂量三价灭活疫苗（IIV3-SD[每株血凝素15 μ g]）在65岁及以上成年人中的作用。在2011-2012年（第1年）和2012-2013年（第2年）北半球流感季节进行了相对疗效、有效性、安全性（严重不良事件）和免疫原性（血凝抑制[HAI]滴度）的评估。结果来自美国和加拿大126个研究中心的31989名参与者被纳入研究，其中15991名随机分配到IIV3-HD组，15998名随机分配到IIV3-SD组。在意向治疗分析中，IIV3-HD组的228名参与者（1.4%）和IIV3-SD组的301名参与者（1.9%）患有实验室确诊的流感，这些流感是由与方案定义的流感样疾病相关的任何病毒类型或亚型引起的（相对疗效为24.2%；95%可信区间[CI]， 9.7至36.5）。在安全监测期间，IIV3-HD组中有1323人（8.3%）报告了至少一次严重不良事件，而IIV3-SD组中有1442人（9.0%）报告了至少一次严重不良事件（相对危险度，0.92;95% CI, 0.85 - 0.99）。接种疫苗后，IIV3-HD组的血凝素抗体滴度和血清保护率（血凝素抗体滴度>= 1:40的参与者百分比）显著升高。结论在65岁及以上的人群中，IIV3-HD诱导的抗体反应明显高于IIV3-SD，对实验室确认的流感疾病提供了更好的保护。
BACKGROUNDAs compared with a standard-dose vaccine, a high-dose, trivalent, inactivated influenza vaccine (IIV3-HD) improves antibody responses to influenza among adults 65 years of age or older. This study evaluated whether IIV3-HD also improves protection against laboratory-confirmed influenza illness.METHODSWe conducted a phase IIIb-IV, multicenter, randomized, double-blind, active-controlled trial to compare IIV3-HD (60 mu g of hemagglutinin per strain) with standard-dose trivalent, inactivated influenza vaccine (IIV3-SD [15 mu g of hemagglutinin per strain]) in adults 65 years of age or older. Assessments of relative efficacy, effectiveness, safety (serious adverse events), and immunogenicity (hemagglutination-inhibition [HAI] titers) were performed during the 2011-2012 (year 1) and the 2012-2013 (year 2) northern-hemisphere influenza seasons.RESULTSA total of 31,989 participants were enrolled from 126 research centers in the United States and Canada (15,991 were randomly assigned to receive IIV3-HD, and 15,998 to receive IIV3-SD). In the intention-to-treat analysis, 228 participants in the IIV3-HD group (1.4%) and 301 participants in the IIV3-SD group (1.9%) had laboratory-confirmed influenza caused by any viral type or subtype associated with a protocol-defined influenza-like illness (relative efficacy, 24.2%; 95% confidence interval [CI], 9.7 to 36.5). At least one serious adverse event during the safety surveillance period was reported by 1323 (8.3%) of the participants in the IIV3-HD group, as compared with 1442 (9.0%) of the participants in the IIV3-SD group (relative risk, 0.92; 95% CI, 0.85 to 0.99). After vaccination, HAI titers and seroprotection rates (the percentage of participants with HAI titers >= 1:40) were significantly higher in the IIV3-HD group.CONCLUSIONSAmong persons 65 years of age or older, IIV3-HD induced significantly higher antibody responses and provided better protection against laboratory-confirmed influenza illness than did IIV3-SD.