Clinical study and stability assessment of a novel transcutaneous influenza vaccination using a dissolving microneedle patch

被引：174

作者：

Hirobe, Sachiko ^{[1
]}

Azukizawa, Hiroaki ^{[2
]}

Hanafusa, Takaaki ^{[2
]}

Matsuo, Kazuhiko ^{[1
]}

Quan, Ying-Shu ^{[3
]}

Kamiyama, Fumio ^{[3
]}

Katayama, Ichiro ^{[2
]}

Okada, Naoki ^{[1
]}

Nakagawa, Shinsaku ^{[1
]}

机构：

[1] Osaka Univ, Grad Sch Pharmaceut Sci, Lab Biotechnol & Therapeut, Suita, Osaka 5650871, Japan

[2] Osaka Univ, Grad Sch Med, Dept Dermatol, Course Integrated Med, Suita, Osaka 5650871, Japan

[3] CosMED Pharmaceut Co Ltd, Minami Ku, Kyoto 6018014, Japan

来源：

BIOMATERIALS | 2015年 / 57卷

关键词：

Drug delivery; Hyaluronic acid; Immune response; ELISA; IMMUNIZATION; VACCINES; VIRUS; EFFICACY; PROTECTS; ARRAY;

D O I：

10.1016/j.biomaterials.2015.04.007

中图分类号：

R318 [生物医学工程];

学科分类号：

100103 [病原生物学];

摘要：

Transcutaneous immunization (TCI) is an attractive vaccination method compared with conventional injectable vaccines because it is easier to administer without pain. We developed a dissolving microneedle patch (MicroHyala, MH) made of hyaluronic acid and showed that transcutaneous vaccination using MH induced a strong immune response against various antigens in mice. In the present study, we investigated the clinical safety and efficacy of a novel transcutaneous influenza vaccine using MH (flu-MH), which contains trivalent influenza hemagglutinins (15 mu g each). Subjects of the TCI group were treated transcutaneously with flu-MH, and were compared with subjects who received subcutaneous injections of a solution containing 15 mu g of each influenza antigen (SCI group). No severe local or systemic adverse events were detected in either group and immune responses against A/H1N1 and A/H3N2 strains were induced equally in the TCI and SCI groups. Moreover, the efficacy of the vaccine against the B strain in the TCI group was stronger than that in the SCI group. Influenza vaccination using MH is promising for practical use as an easy and effective method to replace conventional injections systems. (C) 2015 Elsevier Ltd. All rights reserved.

引用

页码：50 / 58

页数：9

共 17 条

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