Abstract
Epidermal powder immunization (EPI) can efficiently deliver powdered protein vaccines to the epidermis. A phase I clinical trial was conducted to evaluate powdered trivalent influenza vaccine delivered using the PowderJect ND5.2 delivery system. Subjects received either Fluvirin ® IM injection (15 μg of each influenza strain), a single EPI vaccination (15 μg of each influenza strain) or two adjacent EPI (total of 30 μg of each influenza strain). Systemic reactogenicity was similar between control and EPI vaccines. Site reactions following EPI were primarily mild and self-limiting. Seroconversions, titer increases and geometric mean titers to all strains were equivalent or higher in EPI-immunized groups than in controls. Powdered influenza vaccine delivered by EPI is safe and elicits humoral immune responses in humans.
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