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关于 Soluvia™ 许可的微注射系统皮内接种流感疫苗的现有证据。

Current evidence on intradermal influenza vaccines administered by Soluvia™ licensed micro injection system.

机构信息

Department of Health Sciences, University of Genoa, Genoa, Italy.

出版信息

Hum Vaccin Immunother. 2012 Jan;8(1):67-75. doi: 10.4161/hv.8.1.18419. Epub 2012 Jan 1.

Abstract

Among the several strategies explored for (1) the enhancement of the immune response to influenza immunization, (2) the improvement of the vaccine acceptability and (3) the overcoming of the egg-dependency for vaccine production, intradermal administration of influenza vaccine emerges as a promising alternative to conventional intramuscular route, thanks to the recent availability of new delivery devices and the perception of advantages in terms of immunogenicity, safety, reduction of antigen content and acceptability. Data from clinical trials performed in children, adults < 60 y and elderly people and post-marketing surveillance demonstrate that actually, licensed intradermal influenza vaccines, Intanza™ 9 and 15 µg and Fluzone™ Intradermal, administered by the microinjection system Soluvia™, show an excellent acceptability, tolerability and safety profile. Formulations containing 9 and 15 μg per strain demonstrate, respectively, comparable and superior immunogenicity than conventional intramuscular vaccines. Licensed intradermal influenza vaccines can be considered a valid alternative to standard intramuscular vaccination offering significant advantages in low-responder populations and helping to increase influenza vaccination coverage rates especially in people with fear of needles or high apprehension associated with annual vaccination.

摘要

在探索增强流感免疫接种的免疫反应、提高疫苗可接受性和克服疫苗生产对鸡蛋的依赖的几种策略中,由于新型给药装置的出现以及在免疫原性、安全性、抗原含量减少和可接受性方面的优势认知,皮内接种流感疫苗成为一种很有前途的替代肌肉内常规途径的方法。在儿童、<60 岁成年人和老年人中进行的临床试验和上市后监测数据表明,实际上,通过微注射系统 Soluvia™ 接种的 9 和 15 µg 剂量的 Intanza™ 和 Fluzone™ 皮内用流感疫苗,具有极好的可接受性、耐受性和安全性。每株含有 9 和 15 µg 的制剂分别显示出与传统肌肉内疫苗相当的和更优的免疫原性。已许可的皮内用流感疫苗可被视为标准肌肉内疫苗接种的有效替代方案,为低应答者人群提供显著优势,并有助于提高流感疫苗接种覆盖率,特别是在对针有恐惧或对每年接种高度担忧的人群中。

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本文引用的文献

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Immunogenicity and safety of intradermal influenza vaccine in children.皮内流感疫苗在儿童中的免疫原性和安全性。
Vaccine. 2011 Oct 13;29(44):7606-10. doi: 10.1016/j.vaccine.2011.08.021. Epub 2011 Aug 17.
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Intradermal delivery of vaccines: potential benefits and current challenges.皮内递送疫苗:潜在的益处和当前的挑战。
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