Preclinical and clinical study of influenza microneedle vaccine and analysis of immunity induction mechanism

2018 Fiscal Year Final Research Report

• Project/Area Number: 16H05112
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: Osaka University
• Principal Investigator: Nakagawa Shinsaku 大阪大学, 薬学研究科, 教授 (70207728)
• Co-Investigator(Kenkyū-buntansha): 浅田 秀夫 奈良県立医科大学, 医学部, 教授 (60252681)
• Research Collaborator: Okada Naoki ; Hirobe Sachiko ; Azukizawa Hiroaki
• Project Period (FY): 2016-04-01 – 2019-03-31
• Keywords: ワクチン / 経皮免疫 / インフルエンザ

Outline of Final Research Achievements

A novel microneedle (MN) vaccine was developed with the practical application of a transdermal vaccine in mind, and its safety and efficacy were evaluated in preclinical research and human clinical research. As a result, the novel MN using polyglycolic acid is excellent in skin puncture properties, and animal experiments using mice and rats confirmed its safety and effectiveness. We also clarified some of the immune induction mechanisms in transdermal vaccines. Furthermore, based on these results, we evaluated the safety and efficacy of a novel MN vaccine preparation coated with tetravalent influenza HA antigen in humans. As a result, an increase in antigen-specific antibody titer was confirmed without showing serious side reactions.

Free Research Field

生物薬剤学

Academic Significance and Societal Importance of the Research Achievements

今回、実用化を目指した経皮ワクチン製剤の開発を目的に、ポリグリコール酸(PG)を用いた新規マイクロニードル(PGA-MN）ワクチンの開発研究を実施した。このPG-MNを経皮ワクチン製剤として開発するに当たり、皮膚に対する穿刺特性や針の折損、薬物の溶出特性等の物理化学的特性を明らかにした事、さらに経皮ワクチンにおける免疫誘導機構の一部を明らかにした事、動物実験での安全性と有効性を示せた事について、学術的意義は大きい。さらにヒト臨床研究において安全性と有効性を示せた事は、学術的意義が大きく、また実用化が望まれている状況から考えると社会的意義も大きい。