title: Clinical evaluation of a novel microneedle device for intradermal delivery of an influenza vaccine: are all delivery methods the same?
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.
authors.affiliation: NanoPass Technologies Ltd., 3 Golda Meir Street, Nes Ziona 7403648, Israel. Electronic address: yotam@nanopass.com.
authors.forename: Yotam
authors.initials: Y
authors.lastname: Levin
authors.affiliation: NanoPass Technologies Ltd., 3 Golda Meir Street, Nes Ziona 7403648, Israel. Electronic address: efrat@nanopass.com.
authors.forename: Efrat
authors.initials: E
authors.lastname: Kochba
authors.affiliation: Crucell Holland B.V., Archimedesweg 4, 2333 CN Leiden, The Netherlands. Electronic address: richard.kenney@immunedesign.com.
authors.forename: Richard
authors.initials: R
authors.lastname: Kenney
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004306:Dose-Response Relationship, Immunologic; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D009981:Influenza B virus; D007252:Influenza Vaccines / Q000008:administration & dosage*; D007271:Injections, Intradermal / Q000295:instrumentation*; D009339:Needles; D022721:Vaccines, Virosome / Q000008:administration & dosage
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D022721:Vaccines, Virosome
keywords: Dose-sparing; Immunogenicity; Influenza vaccination; Intradermal; Mantoux; Microneedle device