Abstract

Methods A Phase I study was conducted with i plasmid DNA vaccine, containing the CryJ2 allergen from Japanese Red Cedar inserted into the Lysosomal Associated Membrane nucleic acid sequence. Previouslyy sensitized Japanesei, were consented in English/Japanese, received four doses and assessed over 132 days for the safety of this vaccine. Group 1 contained non-sensitive and Groups 2 & 3 sensitive subjects as defined by +/skin test to JRC, Mountain cedar and CryJ2 allergens. All subjects received 4 doses at 14 day intervals. Safety data through 132 days after the 1st vaccination showed 85% of the adverse events (AE’s) were mild, mainly injection site erythema, swelling and pain, the majority occurring in Group 3.t All AEs were of a transient nature, requiring no medical attention. CryJ2-LAMP-Vax did not induce IgE CryJ2 specific titer changes, nor CryJ2 specific IgG titers. Prior to each vaccination and at 72 and 132 days, subjects tested negative for anti-LAMP antibodies. These clinical and biomarker data suggested that the plasmid vaccine was safe.

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