Adjuvant compositions and methods for enhancing immune responses to polynucleotide-based vaccines

Abstract

The invention provides adjuvants, immunogenic compositions, and methods useful for polynucleotide-based vaccination and immune response. In particular, the invention provides an adjuvant of cytofectin:co-lipid mixture wherein cytofectin is GAP-DMORIE.

1 - 66 . (canceled) 
     
     
         67 . A method for prophylactically or therapeutically treating a bacterial associated disease of a mammal, comprising administering to said mammal an immunogenic composition comprising:
 (a) one or more immunogen-encoding polynucleotides associated with said bacterial associated disease, and   (b) an adjuvant composition comprising a (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt and one or more co-lipids;   wherein an immunogen is expressed in said mammal in an amount sufficient to generate an immune response to said immunogen.   
     
     
         68 . The method of  claim 67 , wherein said (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt is (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium bromide (GAP-DMORIE). 
     
     
         69 . The method of  claim 67 , wherein said one or more co-lipids is a phosphatidylethanolamine. 
     
     
         70 . The method of  claim 69 , wherein said phosphatidylethanolamine is 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE). 
     
     
         71 . The method of  claim 69 , wherein said phosphatidylethanolamine is 1,2-diphytanoyl-glycero-3-phosphoethanolamine (DPyPE). 
     
     
         72 . The method of  claim 69 , wherein said phosphatidylethanolamine is 1,2-dimyristoyl-glycero-3-phosphoethanolamine (DMPE). 
     
     
         73 . The method of  claim 67 , wherein said molar ratio of (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt to co-lipid is from about 9:1 to about 1:9. 
     
     
         74 . The method of  claim 67 , wherein said molar ratio of (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt to co-lipid is from about 4:1 to about 1:4. 
     
     
         75 . The method of  claim 67 , wherein said molar ratio of (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt to co-lipid is from about 2:1 to about 1:2. 
     
     
         76 . The method of  claim 67 , wherein said molar ratio of (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt to co-lipid is about 1:1. 
     
     
         77 . A method for prophylactically or therapeutically treating abnormal cell growth in a mammal, comprising administering to said mammal an immunogenic composition comprising:
 (a) one or more immunogen-encoding polynucleotides associated with abnormal cell growth, and   (b) an adjuvant composition comprising a (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt and one or more co-lipids; and   wherein an immunogen is expressed in said mammal in an amount sufficient to generate an immune response to said immunogen.   
     
     
         78 . The method of  claim 77 , wherein said (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt is (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium bromide (GAP-DMORIE). 
     
     
         79 . The method of  claim 77 , wherein said one or more co-lipids is a phosphatidylethanolamine. 
     
     
         80 . The method of  claim 79 , wherein said phosphatidylethanolamine is 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE). 
     
     
         81 . The method of  claim 79 , wherein said phosphatidylethanolamine is 1,2-diphytanoyl-sn-glycero-3-phosphoethanolamine (DPyPE). 
     
     
         82 . The method of  claim 79 , wherein said phosphatidylethanolamine is 1,2-dimyristoyl-glycero-3-phosphoethanolamine (DMPE). 
     
     
         83 . The method of  claim 77 , wherein said molar ratio of (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt to co-lipid is from about 9:1 to about 1:9. 
     
     
         84 . The method of  claim 77 , wherein said molar ratio of (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt to co-lipid is from about 4:1 to about 1:4. 
     
     
         85 . The method of  claim 77 , wherein said molar ratio of (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt to co-lipid is from about 2:1 to about 1:2. 
     
     
         86 . The method of  claim 77 , wherein said molar ratio of (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminium salt to co-lipid is about 1:1.