US2008213306A1PendingUtilityA1

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

72
Assignee: VICAL INCPriority: Mar 26, 1999Filed: Aug 17, 2007Published: Sep 4, 2008
Est. expiryMar 26, 2019(expired)· nominal 20-yr term from priority
Inventors:Carl J. Wheeler
A61K 39/39A61P 31/00A61K 9/1272A61P 33/00A61K 47/6911A61K 2039/53A61P 31/12A61P 31/04Y10S977/802A61P 37/08A61K 2039/57A61K 2039/55511A61P 37/04A61P 35/00A61K 31/7088Y02A50/30
72
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Claims

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.

Claims

exact text as granted — not AI-modified
1 - 66 . (canceled) 
     
     
         67 . A composition comprising (a) an immunogen-encoding polynucleotide or an immunogenic polypeptide and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, wherein said composition elicits an increased antibody titer compared to said polynucleotide or said polypeptide alone. 
     
     
         68 . The composition of  claim 67 , wherein said cytofectin is selected from said group consisting of:
 (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(tetradecyloxy)-1-propanaminium salt,   (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(dodecyloxy)-1-propanaminium salt,   (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(decyloxy)-1-propanaminium salt,   (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(syn-9-octadeceneyloxy)-1-propanaminium salt,   (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminum salt, (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-tetradecyloxy)-1-propanaminium salt, (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-dodecyloxy)-1-propanaminium salt,   (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-hexadecyloxy)-1-propanaminium salt, and 2,3-dioleyloxy-N-(2-(sperminecarboxamido)ethyl)-N,N-dimethyl-1-propanaminium pentahydrochloride (DOSPA).   
     
     
         69 . The composition of  claim 68 , wherein said cytofectin is (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(tetradecyloxy)-1-propanaminium bromide (DMRIE). 
     
     
         70 . The composition of  claim 68 , wherein said cytofectin is (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(dodecyloxy)-1-propanaminium bromide (DLRIE). 
     
     
         71 . The composition of  claim 68 , wherein said cytofectin is (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(decyloxy)-1-propanaminium bromide (DDRIE). 
     
     
         72 . The composition of  claim 68 , wherein said cytofectin is (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(syn-9-octadeceneyloxy)-1-propanaminium bromide (DORIE). 
     
     
         73 . The composition of  claim 68 , wherein said cytofectin is (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminum bromide (DMORIE). 
     
     
         74 . The composition of  claim 68 , wherein said cytofectin is (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-tetradecyloxy)-1-propanaminium bromide (GAP-DMRIE). 
     
     
         75 . The composition of  claim 68 , wherein said cytofectin is (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-dodecyloxy)-1-propanaminium bromide (GAP-DLRIE). 
     
     
         76 . The composition of  claim 68 , wherein said cytofectin is (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-hexadecyloxy)-1-propanaminium bromide (GAP-DPRIE). 
     
     
         77 . The composition of  claim 67 , wherein said cytofectin comprises a fourteen-carbon chain cytofectin. 
     
     
         78 . The method of  claim 67 , wherein said one or more co-lipids is a phosphatidylethanolamine. 
     
     
         79 . The composition of  claim 78 , wherein said phosphatidylethanolamine is selected from the group consisting of 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE), 1,2-diphytanoyl-sn-glycero-3-phosphoethanolamine (DPyPE), and 1,2-dimyristoyl-glycero-3-phosphoethanolamine (DMPE). 
     
     
         80 . The composition of  claim 67 , wherein said polynucleotide is DNA, RNA, or a nucleic acid oligomer. 
     
     
         81 . The composition of  claim 67 , wherein said polynucleotide is a linear or circular polynucleotide. 
     
     
         82 . The composition of  claim 67 , wherein said polynucleotide is all or part of a plasmid DNA. 
     
     
         83 . The composition of  claim 67 , wherein said polynucleotide encodes a viral polypeptide associated with viral infection in a mammal. 
     
     
         84 . The composition of  claim 67 , wherein said polynucleotide encodes a bacterial polypeptide associated with bacterial infection in a mammal. 
     
     
         85 . The composition of  claim 67 , wherein said polynucleotide encodes a fungal polypeptide associated with fungal infection in a mammal. 
     
     
         86 . The composition of  claim 67 , wherein said polynucleotide encodes a parasite polypeptide associated with parasitic infection in a mammal. 
     
     
         87 . The composition of  claim 67 , wherein said polynucleotide encodes a polypeptide associated with abnormal cell growth in a mammal. 
     
     
         88 . The composition of  claim 67 , wherein said polynucleotide encodes a polypeptide associated with an allergenic reaction in a mammal. 
     
     
         89 . The composition of  claim 67 , wherein said polypeptide is a viral polypeptide associated with viral infection in a mammal. 
     
     
         90 . The composition of  claim 67 , wherein said polypeptide is a bacterial polypeptide associated with bacterial infection in a mammal. 
     
     
         91 . The composition of  claim 67 , wherein said polypeptide is a fungal polypeptide associated with fungal infection in a mammal. 
     
     
         92 . The composition of  claim 67 , wherein said polypeptide is a parasite polypeptide associated with parasitic infection in a mammal. 
     
     
         93 . The composition of  claim 67 , wherein said polypeptide is associated with abnormal cell growth in a mammal. 
     
     
         94 . The composition of  claim 67 , wherein said polypeptide is associated with an allergenic reaction in a mammal. 
     
     
         95 . A method for enhancing an immune response in a mammal comprising: administering into a tissue or cavity of said mammal a composition comprising (a) an immunogen-encoding polynucleotide or an immunogenic polypeptide and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, wherein said composition is administered to said mammal in an amount sufficient to generate an immune response to said polynucleotide or said polypeptide, and wherein said composition elicits an increased antibody titer compared to said polynucleotide or said polypeptide alone. 
     
     
         96 . The composition of  claim 95 , wherein said cytofectin is selected from said group consisting of:
 (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(tetradecyloxy)-1-propanaminium salt,   (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(dodecyloxy)-1-propanaminium salt,   (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(decyloxy)-1-propanaminium salt,   (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(syn-9-octadeceneyloxy)-1-propanaminium salt,   (±)-N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(syn-9-tetradeceneyloxy)-1-propanaminum salt, (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-tetradecyloxy)-1-propanaminium salt, (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-dodecyloxy)-1-propanaminium salt,   (±)-N-(3-aminopropyl)-N,N-dimethyl-2,3-(bis-hexadecyloxy)-1-propanaminium salt, and 2,3-dioleyloxy-N-(2-(sperminecarboxamido)ethyl)-N,N-dimethyl-1-propanaminium pentahydrochloride (DOSPA).   
     
     
         97 . The composition of  claim 95 , wherein said cytofectin comprises a fourteen-carbon chain cytofectin. 
     
     
         98 . The method of  claim 95 , wherein said one or more co-lipids is a phosphatidylethanolamine. 
     
     
         99 . The method of  claim 98 , wherein said phosphatidylethanolamine is selected from said group consisting of 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE), 1,2-diphytanoyl-sn-glycero-3-phosphoethanolamine (DPyPE), and 1,2-dimyristoyl-glycero-3-phosphoethanolamine (DMPE). 
     
     
         100 . The method of  claim 95 , wherein said mammal is a human. 
     
     
         101 . The method of  claim 95 , wherein said composition is a pharmaceutical composition. 
     
     
         102 . A method for providing a mammal a prophylactic or therapeutic treatment associated with a viral infection comprising: administering to said mammal a composition comprising (a) one or more immunogen-encoding polynucleotide or immunogenic polypeptide associated with said viral infection, and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, wherein said composition is administered to said mammal in an amount sufficient to generate an immune response to said polynucleotide or said polypeptide. 
     
     
         103 . A method for providing a mammal a prophylactic or therapeutic treatment associated with a bacterial infection comprising: administering to said mammal a composition comprising (a) one or more immunogen-encoding polynucleotide or immunogenic polypeptide associated with said bacterial infection, and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, wherein said composition is administered to said mammal in an amount sufficient to generate an immune response to said polynucleotide or said polypeptide. 
     
     
         104 . A method for providing a mammal a prophylactic or therapeutic treatment associated with a fungal infection comprising: administering to said mammal a composition comprising (a) one or more immunogen-encoding polynucleotide or immunogenic polypeptide associated with said fungal infection, and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, wherein said composition is administered to said mammal in an amount sufficient to generate an immune response to said polynucleotide or said polypeptide. 
     
     
         105 . A method for providing a mammal a prophylactic or therapeutic treatment associated with a parasitic infection comprising: administering to said mammal a composition comprising (a) one or more immunogen-encoding polynucleotide or immunogenic polypeptide associated with said parasitic infection, and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, wherein said composition is administered to said mammal in an amount sufficient to generate an immune response to said polynucleotide or said polypeptide. 
     
     
         106 . A method for providing a mammal a prophylactic or therapeutic treatment associated with a abnormal cell growth comprising: administering to said mammal a composition comprising (a) one or more immunogen-encoding polynucleotide or immunogenic polypeptide associated with said abnormal cell growth, and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, wherein said composition is administered to said mammal in an amount sufficient to generate an immune response to said polynucleotide or said polypeptide. 
     
     
         107 . A method for providing a mammal a prophylactic or therapeutic treatment associated with an allergenic reaction in said mammal comprising:
 administering to said mammal a composition comprising (a) one or more immunogen-encoding polynucleotide or immunogenic polypeptide associated with said allergenic reaction, and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, wherein said composition is administered to said mammal in an amount sufficient to generate an immune response to said polynucleotide or said polypeptide.   
     
     
         108 . A pharmaceutical kit comprising a container holding (a) one or more immunogen-encoding polynucleotide or immunogenic polypeptide, and (b) an adjuvant comprising a ten- to eighteen-carbon chain cytofectin and one or more co-lipids, said wherein said one or more immunogen-encoding polynucleotide or immunogenic polypeptide is provided in a prophylactically or therapeutically effective amount to treat a mammal.

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