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

Author: Sachiko Hirobe, Hiroaki Azukizawa, Takaaki Hanafusa, Kazuhiko Matsuo, Ying-Shu Quan, Fumio Kamiyama, Ichiro Katayama, Naoki Okada, Shinsaku Nakagawa


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 μg 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 μg 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.


Type Journal article
Language English
Country Not Specified
Journal Biomaterials
Volume 57
Publisher Elsevier
Year 2015
Disease , Drug delivery , ELISA , Hyaluronic acid , Immune response , Influenza
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Added on 23 February 2017 10:19:28
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