Cationic lipid vaccine compositions and methods of use

Abstract

The present disclosure provides vaccine compositions comprising at least one adjuvant and at least one therapeutic factor. The disclosure also provides methods of reducing an immune suppressor cell population in a mammal, methods of augmenting an immune response in a mammal, and methods of treating diseases in a mammal utilizing the vaccine compositions.

What is claimed is: 
     
         1 . A method of reducing a myeloid derived suppressor cell (MDSC) population in a mammal, said method comprising the step of administering an effective amount of a composition to the mammal, wherein the composition comprises a cationic lipid, a therapeutic factor, and a cancer antigen;
 wherein the therapeutic factor is selected from the group consisting of interleukins 1-18, stem cell factor, basic FGF, EGF, G-CSF, GM-CSF, FLK 2 ligand, HILDA, MPA 1.alpha., TGF-b, TGF-.alpha., M-CSF, IFN-.gamma., IFN-.alpha., IFN-B, soluble CD23, LIF, and combinations thereof;   wherein the cancer antigen is selected from the group consisting of a prostrate-associated antigen, breast cancer associated antigen, T-cell receptor gamma alternate reading frame protein (TARP), mucin, MUC-1, or MUC-1,   and wherein the composition is in a dosage sufficient to reduce a MDSC population in a subject.   
     
     
         2 . The method of  claim 1 , wherein the cationic lipid is selected from the group consisting of DOTAP, DOTMA, DOEPC, and combinations thereof. 
     
     
         3 . The method of  claim 1 , wherein the cationic lipid is DOTAP. 
     
     
         4 . The method of  claim 1 , wherein the cationic lipid is an enantiomer of the cationic lipid. 
     
     
         5 . The method of  claim 4 , wherein the enantiomer is R-DOTAP. 
     
     
         6 . The method of  claim 1 , wherein the therapeutic factor is a cytokine, and wherein the cytokine is GM-CSF. 
     
     
         7 . The method of  claim 1 , wherein the composition further comprises one or more cancer antigens. 
     
     
         8 . The method of  claim 1 , wherein the cancer antigen is T-cell receptor gamma alternate reading frame protein (TARP). 
     
     
         9 . The method of  claim 1 , wherein the cancer antigen is mucin, MUC-1, or MUC-1. 
     
     
         10 . A method of augmenting an immune response in a mammal, said method comprising the step of administering an effective amount of a vaccine composition to the mammal, wherein the vaccine composition comprises a cationic lipid, a therapeutic factor, and a cancer antigen;
 wherein the therapeutic factor is selected from the group consisting of interleukins 1-18, stem cell factor, basic FGF, EGF, G-CSF, GM-CSF, FLK 2 ligand, HILDA, MPA 1.alpha., TGF-b, TGF-.alpha., M-CSF, IFN-.gamma., IFN-.alpha., IFN-B, soluble CD23, LIF, and combinations thereof,   wherein the cancer antigen is selected from the group consisting of a prostrate-associated antigen, breast cancer associated antigen, T-cell receptor gamma alternate reading frame protein (TARP), mucin, MUC-1, or MUC-1,   and wherein the vaccine composition is in a dosage sufficient to reduce a MDSC population in a subject.   
     
     
         11 . The method of  claim 10 , wherein the reduction results in an increase in T-cell response in the mammal. 
     
     
         12 . The method of  claim 11 , wherein the T-cell response is a CD8+ T-cell response. 
     
     
         13 . The method of  claim 10 , wherein the cationic lipid is selected from the group consisting of DOTAP, DOTMA, DOEPC, and combinations thereof. 
     
     
         14 . The method of  claim 13 , wherein the cationic lipid is DOTAP. 
     
     
         15 . The method of  claim 14 , wherein the adjuvant cationic lipid is an enantiomer of the cationic lipid. 
     
     
         16 . The method of  claim 15 , wherein the enantiomer is R-DOTAP. 
     
     
         17 . The method of  claim 10 , wherein the therapeutic factor is a cytokine, and wherein the cytokine is GM-CSF. 
     
     
         18 . The method of  claim 10 , wherein the composition further comprises one or more cancer antigens. 
     
     
         19 . The method of  claim 10 , wherein the cancer antigen is T-cell receptor gamma alternate reading frame protein (TARP). 
     
     
         20 . The method of  claim 10 , wherein the cancer antigen is mucin, MUC-1, or MUC-1.