Enhancement of an immune response by administration of a cationic lipid-DNA complex (CLDC)
This invention relates to a method for vaccination which is effective for eliciting an enhanced antigen-specific immune response in a mammal, fish or bird. The method is particularly effective for protecting a mammal, fish or bird from a disease including cancer, a disease associated with allergic inflammation, or an infectious disease. Also disclosed are therapeutic compositions useful in such a method.
1. A method for eliciting an immune response in a mammal, fish or bird comprising:
administering to a mammal, fish or bird a therapeutic dose of a cationic lipid DNA complex (CLDC);
administering to a mammal, fish or bird a therapeutic dose of an adjuvanted or unadjuvanted vaccine comprising a protein, inactivated virus, split virion, or lipopolysaccharide;
wherein said CLDC is administered via an intravenous, intraperitoneal, inhalation or in ovo route;
wherein said vaccine is administered via an intravenous, subcutaneous, intramuscular, intranasal or in ovo route; and
wherein said vaccine is administered concomitantly with or 0-7 days after said CLDC administration.
2. The method of claim 1 wherein the immune response is an enhanced antigen-specific immune response.
3. The method of claim 1 wherein said adjuvanted vaccine comprises one or more of the following adjuvants:
a cationic lipid DNA complex (CLDC), alum, Monophosphoryl Lipid A (MPL), QS21, or CpG oligonucleotide (CPG-ODN).
4. The method of claim 3 wherein said adjuvant comprises CLDC alone.
5. The method of claim 1 wherein said vaccine comprises:
an inactivated influenza A virus, an inactivated trivalent influenza vaccine, a split influenza vaccine, a glycosylated protein, a hepatitis B vaccine, or a lipopolysaccharide.
6. The method of claim 5 wherein said vaccine is adjuvanted.
7. The method of claim 5 wherein said vaccine is a split influenza vaccine.
8. The method of claim 7 wherein said split influenza vaccine is the H5N1 split vaccine.
9. The method of claim 1 wherein the method is for eliciting an immune response in a mammal comprising:
administering a therapeutic CLDC intravenously to the mammal;
administering a therapeutic dose of an adjuvanted or unadjuvanted vaccine intramuscularly or subcutaneously to the mammal;
administering said vaccine concomitantly with or 0-7 days after said CLDC administration.
10. The method of claim 9 wherein said vaccine comprises:
an inactivated influenza A virus, an inactivated trivalent influenza vaccine, a split influenza vaccine, a glycosylated protein, a hepatitis B vaccine, or a lipopolysaccharide.
11. The method of claim 9 wherein said adjuvanted vaccine comprises one or more of the following adjuvants:
a cationic lipid DNA complex (CLDC), alum, Monophosphoryl Lipid A (MPL), QS21, or CpG oligonucleotide (CPG-ODN).
12. The method of claim 9 wherein said adjuvant comprises CLDC alone.
13. The method of claim 9 wherein the immune response is an enhanced antigen-specific immune response.
14. The method of claim 2 wherein the enhanced immune response is at least two-fold higher than a control with no CLDC administration.
15. The method of claim 14 wherein the enhanced immune response is approximately six to eight-fold higher than the control.