Influenza virus vaccine composition and methods of use

Abstract

The present invention is directed to enhancing the immune response of a human in need of protection against IV infection by administering in vivo, into a tissue of the human, at least one polynucleotide comprising one or more regions of nucleic acid encoding an IV protein or a fragment, a variant, or a derivative thereof. The present invention is further directed to enhancing the immune response of a human in need of protection against IV infection by administering, in vivo, into a tissue of the human, at least one IV protein or a fragment, a variant, or derivative thereof. The IV protein can be, for example, in purified form or can be an inactivated IV, such as those present in inactivated IV vaccines. The polynucleotide is incorporated into the cells of the human in vivo, and an immunologically effective amount of an immunogenic epitope of an IV, or a fragment, variant, or derivative thereof is produced in vivo. The IV protein (in purified form or in the form of an inactivated IV vaccine) is also administered in an immunologically effective amount.

1 . An isolated polynucleotide comprising a nucleic acid fragment, wherein said nucleic acid fragment is SEQ ID NO: 66. 
     
     
         2 . A vector comprising the polynucleotide of  claim 1 . 
     
     
         3 . The polynucleotide of  claim 1 , further comprising a heterologous nucleic acid ligated to said nucleic acid fragment. 
     
     
         4 . A composition comprising the vector of  claims 2  and a carrier. 
     
     
         5 . The composition of  claim 4 , further comprising a component selected from the group consisting of an adjuvant and a transfection facilitating compound. 
     
     
         6 . The composition of  claim 5 , wherein said component is a cationic lipid. 
     
     
         7 . The composition of  claim 5 , wherein said adjuvant comprises (±)—N-(3-aminopropyl)-N,N-dimethyl-2,3-bis(syn-9-tetradecenyloxy)-1-propanaminium bromide (GAP-DMORIE) and a neutral lipid, wherein said neutral lipid is selected from the group consisting of:
 (a) 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE);   (b) 1,2-diphytanoyl-sn-glycero-3-phosphoethanolamine (DPyPE); and   (c) 1,2-dimyristoyl-glycero-3-phosphoethanolamine (DMPE).   
     
     
         8 . The composition of  claim 6 , wherein said transfection facilitating compound comprises (±)—N-(2-hydroxyethyl)-N,N-dimethyl-2,3-bis(tetradecyloxy)-1-propanaminium bromide (DMRIE). 
     
     
         9 . The composition of  claim 8 , wherein said transfection facilitating compound further comprises a neutral lipid. 
     
     
         10 . The composition of  claim 9 , wherein said neutral lipid is DOPE. 
     
     
         11 . The composition of  claim 8  further comprising a 1:1 molar ratio of GAP-DMORIE and DPyPE. 
     
     
         12 . A method for treating or preventing influenza infection in a vertebrate comprising administering to a vertebrate in need thereof the composition of  claim 4 . 
     
     
         13 . A method for eliciting an immune response to influenza virus in a vertebrate comprising administering to a vertebrate in need thereof the composition of  claim 4 .