Abstract: Transcutaneous immunostimulation administers at least one adjuvant by transcutaneous immunization to a subject who has undergone, is undergoing, or will undergo conventional vaccination or another immune response. A subject is selected for treatment to stimulate the immune response to a conventional vaccine or other immuno-therapy. A suspicion, medical history, or determination by a physician or veterinarian that the subject may fail to respond or only poorly respond to conventional vaccination or other immunotherapy because of age, acquired or congenital immunodeficiency, immunosuppression caused by disease or ablative therapy, or the use of reduced amounts of antigen in the conventional vaccine can be used to select subjects in need of treatment.

Abstract: This invention includes fusion proteins comprising a bacterial ADP-ribosylating exotoxin (bARE), or a variant or portion thereof, fused to a STa exotoxin, or a portion or variant thereof. Optionally, the exotoxins are fused via a peptide linker. The invention also includes compositions formulated for transcutaneous immunizations and/or induction of an immune response by epicutaneous administration comprising an effective amount of a fusion protein comprising a bacterial ADP-ribosylating exotoxin fused to a STa exotoxin. Optionally, the exotoxins are fused via a peptide linker.

Abstract: The invention provides devices for the disruption of one or more layers of skin and methods of their use to administer therapeutic agents, e.g., antigens or drugs. The devices are designed to disrupt a defined area of skin. The defined area can approximate the area that a patch or other suitable vehicle for therapeutic agent, e.g., drug or vaccine, delivery is designed to contact. Exemplary devices employ a mask to define the area to be disrupted. Other devices disrupt a defined area by rotating in place. For devices that employ a mask that is secured to the skin, the invention provides methods of disrupting the stratum corneum by first securing the mask to the skin and then disrupting the skin. For rotating devices, the disrupting member is simply placed against the skin and actuated to effect disruption.

Abstract: Transcutaneous immunostimulation administers at least one adjuvant by transcutaneous immunization to a subject who has undergone, is undergoing, or will undergo conventional vaccination or another immune response. A subject is selected for treatment to stimulate the immune response to a conventional vaccine or other immunotherapy. A suspicion, medical history, or determination by a physician or veterinarian that the subject may fail to respond or only poorly respond to conventional vaccination or other immunotherapy because of age, acquired or congenital immunodeficiency, immunosuppression caused by disease or ablative therapy, or the use of reduced amounts of antigen in the conventional vaccine can be used to select subjects in need of treatment.

Abstract: A transcutaneous immunization system delivers antigen to immune cells through the skin, and induces an immune response in an animal or human. For example, a skin-active adjuvant (e.g., an ADP-ribosylating exotoxin) can be used to induce an antigen-specific immune response (e.g., humoral and/or cellular effectors) after transcutaneous application of a dry formulation containing antigen and adjuvant to skin of the animal or human. The dry formulation may be a powder or a unit-dose patch. Use of adjuvant is not required if the antigen is sufficiently antigenic. Transcutaneous immunization may be induced with or without penetration enhancement.