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一种用于皮内注射流感疫苗的新型微针装置的临床评估:所有给药方法都一样吗?

Clinical evaluation of a novel microneedle device for intradermal delivery of an influenza vaccine: are all delivery methods the same?

作者信息

Levin Yotam, Kochba Efrat, Kenney Richard

机构信息

NanoPass Technologies Ltd., 3 Golda Meir Street, Nes Ziona 7403648, Israel.

Crucell Holland B.V., Archimedesweg 4, 2333 CN Leiden, The Netherlands.

出版信息

Vaccine. 2014 Jul 23;32(34):4249-52. doi: 10.1016/j.vaccine.2014.03.024. Epub 2014 Jun 13.

Abstract

The skin provides the largest immune barrier to infection and is a readily accessible site for vaccination, although intradermal (ID) injection can be challenging. The MicronJet™ microneedle is a novel device that consistently injects antigens very close to the skin's dendritic cells. A dose-sparing ID injection study was conducted in 280 healthy adult volunteers using trivalent virosomal adjuvanted influenza vaccine. ID injection of 3 μg using the MicronJet™ was well tolerated and showed a statistically higher geometric mean fold rise than the same dose ID using a conventional needle (Mantoux technique) for the H1N1 and B strains or a 15 μg intramuscular (IM) injection for the H3N2 strain. Thus, the immune response appears to partially depend on the delivery device and route of injection. The MicronJet™ may allow dose-sparing, yet give a superior response in influenza vaccination and warrants further clinical evaluation.

摘要

皮肤为感染提供了最大的免疫屏障,并且是易于进行疫苗接种的部位,尽管皮内(ID)注射可能具有挑战性。MicronJet™微针是一种新型装置,能够持续将抗原注射到非常接近皮肤树突状细胞的位置。在280名健康成年志愿者中进行了一项使用三价病毒体佐剂流感疫苗的节省剂量皮内注射研究。使用MicronJet™进行3μg的皮内注射耐受性良好,并且对于H1N1和B毒株,其几何平均倍数升高在统计学上高于使用传统针头(曼托试验技术)进行相同剂量的皮内注射,对于H3N2毒株,高于15μg的肌肉注射(IM)。因此,免疫反应似乎部分取决于给药装置和注射途径。MicronJet™可能允许节省剂量,并且在流感疫苗接种中产生更好的反应,值得进一步的临床评估。

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