Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok®) against influenza in healthy adults: A randomized, placebo-controlled trial
Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok®) against influenza in healthy adults: A randomized, placebo-controlled trial
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DOI：
10.1016/j.vaccine.2011.07.128
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发表时间：
2011-10-13
期刊：
影响因子：
5.5
通讯作者：
Cox, Manon
中科院分区：
文献类型：
--
作者：
Treanor, John J.;El Sahly, Hana;Cox, Manon
背景：开发不使用鸡胚作为疫苗生产基质的流感疫苗是一个高度优先事项。我们进行了这项研究，以确定重组，杆状病毒表达的季节性三价流感病毒血凝素（rHA 0）疫苗（FluBlok（R））的保护效力。方法：在美国24个中心的健康成人受试者被随机分配接受单次注射生理盐水安慰剂（2304名受试者），或三价FluBlok含有45微克的每种rHA 0成分（2344名受试者）。在免疫接种前和免疫接种后28天，从一组受试者中采集血清样本，通过血凝抑制（HAI）评估免疫应答。受试者在2007-2008年流感季节和合并鼻和咽拭子病毒分离报告流感样疾病的受试者获得。结果：局部和全身副作用的发生率低，全身副作用的发生率在疫苗组和安慰剂组相似。在78%、81%和52%的FluBlok接受者中分别观察到H1、H3和B组分的HAI抗体应答。FluBlok是44.6%（95%CI，18.8%，62.6%）的有效预防符合CDC流感样疾病病例定义的培养确认的流感，尽管疫苗抗原和循环virus.Conclusions之间存在显着的抗原错配：三价rHA 0疫苗是安全的，免疫原性和有效的预防培养确认的流感疾病，包括对漂移变异的保护。(C)2011爱思唯尔有限公司保留所有权利。
Background: Development of influenza vaccines that do not use embryonated eggs as the substrate for vaccine production is a high priority. We conducted this study to determine the protective efficacy a recombinant, baculovirus-expressed seasonal trivalent influenza virus hemagglutinin (rHA0) vaccine (FluBlok (R)).Methods: Healthy adult subjects at 24 centers across the US were randomly assigned to receive a single injection of saline placebo (2304 subjects), or trivalent FluBlok containing 45 mcg of each rHA0 component (2344 subjects). Serum samples for assessment of immune responses by hemagglutination-inhibition (HAI) were taken from a subset of subjects before and 28 days after immunization. Subjects were followed during the 2007-2008 influenza season and combined nasal and throat swabs for virus isolation were obtained from subjects reporting influenza-like illness.Results: Rates of local and systemic side effects were low, and the rates of systemic side effects were similar in the vaccine and placebo groups. HAI antibody responses were seen in 78%, 81%, and 52% of FluBlok recipients to the H1, H3, and B components, respectively. FluBlok was 44.6% (95% Cl, 18.8%, 62.6%) effective in preventing culture-confirmed influenza meeting the CDC influenza-like illness case definition despite significant antigenic mismatch between the vaccine antigens and circulating viruses.Conclusions: Trivalent rHA0 vaccine was safe, immunogenic and effective in the prevention of culture confirmed influenza illness, including protection against drift variants. (C) 2011 Elsevier Ltd. All rights reserved.