Immunogenicity and safety of inactivated Influenza Split-Virion vaccine administered via a Transdermal Microneedle System

Abstract

The purpose of the study was to evaluate the immunogenicity and safety of an inactivated influenza split virion vaccine administered via a transdermal microneedle system. In this Phase 1, single-center, randomized, controlled study, 90 subjects aged 18 to 40 years received influenza vaccine (strains (A/H1N1, A/H3N2, and B) either via a transdermal microneedle system (“patch”; 10 µg) for 5 or 15 minutes or by Intramuscular (IM) injection (15g). Influenza antibody titers were measured by the hemagglutinin inhibition method and compared to EMEA guidelines for influenza vaccines (seroconversion rate, mean increase in hemagglutinin inhibition titer, and percentage of seroprotected subjects). Safety was assessed through local and systemic adverse events, and specific application site events in the transdermal groups. At Day 21, the EMEA criteria were met in all treatment groups for all three influenza strains. The immunogenicity response was similar between all three groups and increased antibody levels persisted to Month 6. The transdermal microneedle system was generally well tolerated, although pinpoint red spots, edema, and erythema were noted after patch removal in most subjects. Influenza vaccination administered via a novel transdermal microneedle system was generally well tolerated and provided similar antibody response using a lower dose than IM injection.