Transcutaneous immunization can deliver
antigen to the
immune system through the
stratum corneum without physical or chemical penetration to the
dermis layer of the
skin. This
delivery system induces an
antigen-specific immune response without the use of a
heterologous adjuvant. Although perforation of
intact skin is not required, superficial penetration or micropenetration of the
skin can act as an
enhancer; similarly, hydration may enhance the immune response. This
system can induce
antigen-specific immune effectors after epicutaneous application of a formulation containing one or more antigens. The formulation may initiate processes such as
antigen uptake,
processing, and presentation; Langerhans
cell activation, migration from the
skin to other immune organs, and differentiation to mature dendritic cells; contacting antigen with lymphocytes bearing cognate
antigen receptors on the
cell surface and their stimulation; and combinations thereof. Systemic and / or regional
immunity may be induced. Immune responses that provide prophylactic and / or therapeutic treatments are preferred. Antigenic activities in the formulation may be found in the same molecule, two or more different molecules dissociated from each other, or multiple molecules in a complex formed by covalent or non-covalent bonds. For antigens which are proteinaceous, they may be provided in the formulation as a
polynucleotide for transcutaneous genetic immunization. Besides simple application of a dry or liquid formulation to the skin, patches and other medical devices may be used to deliver antigen for immunization.