Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18-60 years Randomized, controlled, phase III trial
Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18-60 years Randomized, controlled, phase III trial
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DOI：
10.4161/hv.6.4.10961
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发表时间：
2010-04-01
期刊：
影响因子：
--
通讯作者：
Weber, Francoise
中科院分区：
文献类型：
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作者：
Arnou, Robert;Eavis, Patrick;Weber, Francoise
背景资料：疫苗接种是减少流感造成的巨大健康和经济负担的最有效方法，但疫苗接种覆盖率仍然很低，特别是在非老年人中。皮内注射流感疫苗产生有效的免疫应答，并代表了一种替代肌肉注射流感vaccination.Results：三个工业批次的皮内注射疫苗在接种后第21天引起的滴度方面是等效的。皮内和肌内疫苗诱导了相似的接种后滴度，并且满足欧洲流感疫苗监管指南中针对三种流感毒株中的每一种流感毒株规定的所有三项免疫原性标准。两个疫苗组的征集性全身反应特征以及自发报告的不良事件的发生率和类型相似，与灭活流感疫苗的已知安全性特征一致。注射部位反应更频繁与intradermalvaccination.Methods：第三阶段多中心，随机，对照，双盲（三个不同批次的皮内疫苗）研究评估批间一致性，免疫原性和安全性的皮内灭活三价裂解病毒粒子流感疫苗在2,255名18-60岁的成年人。与会者收到了三批皮内疫苗含有9微克血凝素每流感病毒株，或许可的肌肉注射控制疫苗含有15微克血凝素/strain.Conclusions：这种皮内疫苗含有9微克每流感病毒株，提供了一种替代传统的肌肉注射疫苗，具有可靠的生产方法，是同样的免疫原性和良好的耐受性，在成人。该研究在clinicaltrials.gov上注册（标识符NCT 00383539）。
Background: Vaccination is the most effective way of reducing the large health and economic burden of influenza, yet vaccination coverage remains low, particularly among non-elderly adults. Intradermal influenza vaccine produce an effective immune response and represents an alternative to intramuscular influenza vaccination.Results: The three industrial lots of intradermal vaccine were equivalent in terms of post-vaccination titres elicited by day 21. The intradermal and intramuscular vaccines induced similar post-vaccination titres, and satisfied all three immunogenicity criteria set out in the European regulatory guidelines for influenza vaccines for each of the three influenza strains. The solicited systemic reaction profile and the incidence and type of spontaneously reported adverse events were similar in the two vaccine groups and in line with the known safety profile of inactivated influenza vaccines. Injection site reactions were more frequent with intradermal vaccination.Methods: A Phase III multicentre, randomised, controlled, double-blind (for the three different lots of intradermal vaccine) study assessed lot-to-lot consistency, immunogenicity and safety of an intradermal inactivated trivalent split-virion influenza vaccine in 2,255 adults aged 18-60 years. Participants received one of three lots of intradermal vaccine containing 9 mu g of haemagglutinin per influenza strain, or a licensed intramuscular control vaccine containing 15 mu g haemagglutinin/strain.Conclusions: This intradermal vaccine containing 9 mu g per influenza strain, provides an alternative to conventional intramuscular vaccination, has a reliable production method and is equally immunogenic and well tolerated in adults. The study was registered at clinicaltrials.gov (identifier NCT00383539).