Compositions and methods for delivery of genetic material

A method of generating an immune response in an individual against a pathogen comprising administering in vivo to muscle or skin of said individual's body a genetic vaccine facilitator selected from the group consisting of:

• anionic lipids;
• saponins;
• lectins;
• estrogenic compounds;
• hydroxylated lower alkyls;
• dimethyl sulfoxide;
• and urea;
• and,
• a DNA molecule that is dissociated from an infectious agent and comprises a DNA sequence that encodes a protein which comprises at least one epitope that is identical or substantially similar to an epitope of a pathogen antigen, said nucleotide sequence being operably linked to regulatory sequences;
• wherein said DNA molecule is taken up by cells, said DNA sequence is expressed in said cells and an immune response is generated against said antigen.

A method of generating an immune response in an individual against a disease comprising administering in vivo to muscle or skin of said individual's body a genetic vaccine facilitator selected from the group consisting of:

• anionic lipids;
• saponins;
• lectins;
• estrogenic compounds;
• hydroxylated lower alkyls;
• dimethyl sulfoxide;
• and urea;
• and, a DNA molecule that is dissociated from an infectious agent and comprises a DNA sequence that encodes a protein which comprises an epitope identical or substantially similar to an epitope of a protein associated with said disease operatively linked to regulatory sequences;
• wherein said DNA molecule is taken up by cells, said DNA sequence is expressed in said cells and an immune response is generated against said target protein.

A pharmaceutical composition comprising:

• i) a DNA molecule that is dissociated from an infectious agent and comprises a DNA sequence which encodes a protein wherein said DNA sequence is operably linked to regulatory sequences required for expression in a mammal and said protein is selected from the group consisting of:
• proteins which comprise at least one epitope that is identical or substantially similar to an epitope of a pathogen antigen;
• proteins which comprise an epitope identical or substantially similar to an epitope of a protein associated with hyperproliferating cells;
• and proteins which comprise an epitope identical or substantially similar to an epitope of a protein associated with an autoimmune disease;
• and
• ii) a genetic vaccine facilitator selected from the group consisting of anionic lipids;
• saponins;
• lectins;
• estrogenic compounds;
• hydroxylated lower alkyls;
• dimethyl sulfoxide;
• and urea.

A pharmaceutical kit comprising:

• i) a container that comprises a DNA molecule that is dissociated from an infectious agent and comprises a DNA sequence which encodes a protein wherein said DNA sequence is operably linked to regulatory sequences required for expression in a mammal and said protein is selected from the group consisting of:
• proteins which comprise at least one epitope that is identical or substantially similar to an epitope of a pathogen antigen;
• proteins which comprise an epitope identical or substantially similar to an epitope of a protein associated with hyperproliferating cells;
• and proteins which comprise an epitope identical or substantially similar to an epitope of a protein associated with an autoimmune disease;
• and
• ii) a container that comprises a genetic vaccine facilitator selected from the group consisting of:
• anionic lipids;
• saponins;
• lectins;
• estrogenic compounds;
• hydroxylated lower alkyls;
• dimethyl sulfoxide;
• and urea.

A method of delivering a protein into cells of an individual in vivo comprising administering to muscle or skin of said individual's body a genetic vaccine facilitator selected from the group consisting of:

• anionic lipids;
• saponins;
• lectins;
• estrogenic compounds;
• hydroxylated lower alkyls;
• dimethyl sulfoxide;
• and urea;
• and, a DNA molecule that is dissociated from an infectious agent and comprises a DNA sequence that encodes said protein, said DNA sequence operatively linked to regulatory sequences which control the expression of said DNA sequence;
• wherein said DNA molecule is taken up by cells, said DNA sequence is expressed in said cells producing said protein in said cells.