Disclosed and claimed are methods of non-invasive immunization and
drug delivery in an animal and / or methods of inducing a systemic immune or therapeutic response in an animal following topical application of non-replicative vectors, products therefrom and uses for the methods and products therefrom. Also disclosed and claimed are methods of non-invasive immunization and
drug delivery in an animal and / or a method of inducing a systemic immune response or systemic therapeutic response to a
gene product comprising contacting
skin of the animal with
cell-free extracts in an amount effective to induce the response, wherein the extracts are prepared by
filtration of disrupted cells, wherein the
cell comprises and expresses a
nucleic acid molecule. Preferably, the
cell is temporarily disrupted by
sonication, remaining intact and viable after the
sonication. Also, methods are disclosed and claimed for enhancing the
immunogenicity and
efficacy of an epicutaneous vaccine for inducing a systemic immune response to an
antigen, in an animal comprising contacting
skin of the animal with vaccines admixed with heat-shock
protein 27, in an amount effective to induce the response. The methods include contacting
skin of the animal with a vector in an amount effective to induce the systemic immune or therapeutic response. The vector can include and express an exogenous
nucleic acid molecule encoding an
epitope or
gene product of interest. The systemic immune response can be to or from the
epitope or
gene product. The
nucleic acid molecule can
encode an
epitope or
antigen of interest and / or a
nucleic acid molecule that stimulates and / or modulates an immunological response and / or stimulates and / or modulates expression, e.g., transcription and / or translation, such as transcription and / or translation of an endogenous and / or exogenous
nucleic acid molecule; e.g., one or more of influenza
hemagglutinin, influenza
nuclear protein, influenza M2,
tetanus toxin C-fragment,
anthrax protective antigen, anthrax
lethal factor, anthrax
germination factors,
rabies glycoprotein, HBV surface
antigen, HIV gp120, HIV gp160, human
carcinoembryonic antigen,
malaria CSP,
malaria SSP,
malaria MSP, malaria pfg,
botulinum toxin A, and
mycobacterium tuberculosis HSP; and / or a therapeutic, an immunomodulatory gene, such as co- stimulatory gene and / or a
cytokine gene. The immune response can be induced by the vector expressing the
nucleic acid molecule in the animal's cells including epidermal cells. The immune response can also be induced by antigens expressed from the nucleic
acid molecule within the vector. The immune response can be against a
pathogen or a
neoplasm. A prophylactic vaccine or a
therapeutic vaccine or an immunological composition can include the vector. The animal can be a
vertebrate, e.g., a
mammal, such as human, a cow, a horse, a dog, a cat, a goat, a sheep or a pig; or
fowl such as turkey, chicken or duck. The vector can be one or more of a
viral vector, including viral coat, e.g., with some or all
viral genes deleted therefrom, bacterial, protozoan, transposon,
retrotransposon, and
DNA vector, e.g., a recombinant vector; for instance, an adenovirus, such as an adenovirus defective in its E1 and / or E3 and / or E4 region(s) and / or all adenoviral genes.