Polyvalent, primary hiv-1 glycoprotein dna vaccines and vaccination methods

Abstract

Polyvalent, primary isolate nucleic acid compositions for inducing an immune response against HIV is disclosed. The compositions and methods described herein are for the use of a DNA composition that encodes one or more different HIV envelope glycoproteins. The DNA composition can encode an HIV Gag protein. The DNAs encoding one or more HIV proteins are a combination of different nucleic acids, such as DNA plasmids, generated from primary isolate DNA of different HIV major group genetic clades and/or different proteins. HIV protein compositions for inducing an immune response against HIV are disclosed. Methods for using the protein compositions as boosts following administration of the DNA compositions are provided.

1 . A nucleic acid composition comprising a plurality of sets of nucleic acid molecules, each nucleic acid molecule encoding a human immunodeficiency virus (HIV) envelope glycoprotein, wherein each set of nucleic acid molecules encodes a different type of HIV envelope glycoprotein, or comprises a primary isolate sequence from a distinct genetic clade. 
     
     
         2 . The nucleic acid composition of  claim 1 , wherein the nucleic acids comprise DNA plasmids. 
     
     
         3 . (canceled) 
     
     
         4 . The nucleic acid composition of  claim 1 , further comprising a set of nucleic acid molecules encoding a HIV gag protein. 
     
     
         5 . The nucleic acid composition of  claim 1 , wherein the envelope glycoprotein of one or more of the plurality of sets is a HIV-1 envelope glycoprotein. 
     
     
         6 . The nucleic acid composition of  claim 1 , wherein the envelope glycoprotein of one or more of the plurality of sets is a gp120 envelope glycoprotein. 
     
     
         7 - 13 . (canceled) 
     
     
         14 . The nucleic acid composition of  claim 1 , wherein one or more of the sets of nucleic acids comprises optimized codons. 
     
     
         15 - 40 . (canceled) 
     
     
         41 . A protein composition comprising a plurality of sets of isolated human immunodeficiency virus (HIV) envelope glycoprotein molecules, wherein each molecule in the sets comprises a different type of HIV envelope glycoprotein, or comprises a primary isolate sequence from a distinct genetic clade. 
     
     
         42 . The composition of  claim 41 , wherein the envelope glycoprotein of one or more of the plurality of sets is a HIV-1 envelope glycoprotein. 
     
     
         43 . The composition of  claim 41 , wherein the envelope glycoprotein of each set is selected from the group consisting of gp120, gp140, gp160, and gp41. 
     
     
         44 - 60 . (canceled) 
     
     
         61 . A kit comprising:
 a nucleic acid composition of  claim 1 , and instructions for administering the nucleic acid composition to an individual.   
     
     
         62 . The kit of  claim 61 , further comprising a protein composition comprising a set of isolated human immunodeficiency virus (HIV) envelope glycoprotein molecules. 
     
     
         63 . The kit of  claim 61 , wherein the kit further comprises one or more additional sets of isolated HIV envelope glycoproteins, wherein each set is a different type of HIV envelope glycoprotein, or comprises a primary isolate sequence from a distinct genetic clade. 
     
     
         64 . The kit of  claim 61 , wherein one or more of the HIV envelope glycoproteins encoded by the nucleic acid molecules of the nucleic acid composition is of a same type or clade as one or more of the envelope glycoproteins of the protein composition. 
     
     
         65 . (canceled) 
     
     
         66 . A kit comprising:
 a protein composition comprising a set of isolated human immunodeficiency virus (HIV) envelope glycoprotein molecules, wherein each set comprises a different type of HIV envelope glycoprotein, or comprises a primary isolate sequence from a distinct genetic clade; and   instructions for administration of the composition to an individual that has been administered an HIV vaccine.   
     
     
         67 . The kit of  claim 66 , wherein the individual has been administered a nucleic acid HIV vaccine. 
     
     
         68 . The kit of  claim 66 , wherein the protein composition further comprises an excipient. 
     
     
         69 . (canceled) 
     
     
         70 . The kit of  claim 66 , wherein the protein composition further comprises an adjuvant. 
     
     
         71 . (canceled) 
     
     
         72 . The kit of  claim 61 , wherein the kit further comprises instructions for administration to an individual according to a method, the method comprising:
 administering the nucleic acid composition to the individual, and administering a protein composition comprising a set of isolated human immunodeficiency virus (HIV) envelope glycoprotein molecules to the individual, wherein the protein composition is administered after the nucleic acid composition.   
     
     
         73 - 74 . (canceled) 
     
     
         75 . The kit of  claim 72 , wherein the protein composition further comprises one or more additional sets of isolated HIV envelope glycoproteins, wherein each set is a different type of HIV envelope glycoprotein, or comprises a primary isolate sequence from a distinct genetic clade. 
     
     
         76 - 77 . (canceled) 
     
     
         78 . The kit of  claim 61 , further comprising instructions for administration to an individual according to a method, the method comprising: administering the nucleic acid composition to the individual, and administering the protein composition to the individual, wherein the protein composition is administered after the nucleic acid composition. 
     
     
         79 - 80 . (canceled)