This review provides an overview of studies employing particle-mediated epidermal delivery (PMED) or the gene gun to administer DNA vaccines for infectious diseases in preclinical studies employing large animal models and in human clinical trials. It reviews the immunogenicity and protective efficacy of PMED DNA vaccines in nonhuman primates and swine and studies that have directly compared the effectiveness of PMED in these large animal models to existing licensed vaccines and intramuscular or intradermal delivery of DNA vaccines with a needle. Various clinical trials employing PMED have been completed and an overview of the immunogenicity, safety, and tolerability of this approach in humans is described. Finally, efforts currently in progress for commercial development of particle-mediated DNA vaccines are discussed.
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