Materials and methods for immunizing against FIV infection

Abstract

The subject invention pertains to methods and compositions for protecting feline animals from infection by FIV using immunogens derived from primate immunodeficiency viruses, including HIV and SIV. Methods for vaccinating feline animals with the subject vaccine compositions are described. Feline animals vaccinated according to the methods and compositions of the subject invention exhibit protective humoral and cellular immune responses to FIV when challenged with FIV.

1 . A method for inhibiting or preventing infection by feline immunodeficiency virus (FIV) in a feline animal, said method comprising administering to said animal an effective amount of an immunogen derived from a primate immunodeficiency virus.  
     
     
         2 . The method according to  claim 1 , wherein said primate immunodeficiency virus is a human immunodeficiency virus (HIV) or a simian immunodeficiency virus (SIV).  
     
     
         3 . The method according to  claim 2 , wherein said HIV is HIV-1 or HIV-2.  
     
     
         4 . The method according to  claim 3 , wherein said HIV-1 is selected from the group consisting of HIV-1 IIIB , HIV-1 UCD1 , and HIV-1 BRU .  
     
     
         5 . The method according to  claim 1 , wherein said immunogen is a virus infected cell or whole cell-free virus.  
     
     
         6 . The method according to  claim 5 , wherein said virus is treated in a manner to inactivate or attenuate the virus or said virus is replication-defective.  
     
     
         7 . The method according to  claim 6 , wherein said virus is inactivated or attenuated by treatment with paraformaldehyde, formalin, phenol, UV light, or elevated temperature.  
     
     
         8 . The method according to  claim 1 , wherein said immunogen is a polypeptide, or an immunogenic fragment thereof, of said primate immunodeficiency virus.  
     
     
         9 . The method according to  claim 8 , wherein said polypeptide is encoded by the env, gag, pol, tat, rev, vif, vpr, vpu, or nef gene of said primate immunodeficiency virus.  
     
     
         10 . The method according to  claim 8 , wherein said polypeptide is an envelope protein selected from the group consisting of gp120 and gp160, or an immunogenic fragment thereof.  
     
     
         11 . The method according to  claim 8 , wherein said polypeptide is an HIV envelope protein comprising the amino acid sequence shown in SEQ ID NO: 1 or SEQ ID NO: 5, or an immunogenic fragment thereof.  
     
     
         12 . The method according to  claim 8 , wherein said polypeptide is a p24 protein of HIV, or an immunogenic fragment thereof, or a p27 protein of SIV, or an immunogenic fragment thereof.  
     
     
         13 . The method according to  claim 12 , wherein said p24 protein is a p24 protein of HIV-1 UCD1 .  
     
     
         14 . The method according to  claim 1 , wherein said immunogen is a recombinant virus or recombinant expression construct comprising a polynucleotide sequence of a primate immunodeficiency virus.  
     
     
         15 . The method according to  claim 14 , wherein said polynucleotide sequence is an HIV-1, HIV-2, or SIV sequence.  
     
     
         16 . The method according to  claim 14 , wherein said polynucleotide sequence comprises one or more env, gag, pol, tat, rev, vif, vpr, vpu, or nef genes, or an immunogenic fragment thereof, of said primate immunodeficiency.  
     
     
         17 . The method according to  claim 14 , wherein said polynucleotide sequence encodes an HIV gp160, gp120, gp41, p31, p24, p 17, or p7 polypeptide, or an immunogenic fragment thereof.  
     
     
         18 . The method according to  claim 1 , wherein said method further comprises administering an effective amount of an immunogen derived from a feline immunodeficiency virus (FIV) subsequent to the administration of said immunogen derived from said primate immunodeficiency virus.  
     
     
         19 . The method according to  claim 1 , wherein said immunogen is provided or administered with a pharmaceutically acceptable carrier or diluent.  
     
     
         20 . The method according to  claim 1 , wherein said immunogen is provided or administered with one or more adjuvants that increase the immune response of said animal against said immunogen.  
     
     
         21 . The method according to  claim 1 , wherein said immunogen is administered subcutaneously, intraperitoneally, intramuscularly, orally, or via nasal administration.  
     
     
         22 . The method according to  claim 20 , wherein said adjuvant is selected from the group consisting of threonyl muramyl dipeptide (MDP), Ribi Adjuvant System including cell wall skeleton (CWS), Freund's complete adjuvant, Freund's incomplete adjuvant, alum, aluminum hydroxide, and saponin.  
     
     
         23 . The method according to  claim 1 , wherein said immunogen is administered in combination with a cytokine or lymphokine.  
     
     
         24 . The method according to  claim 23 , wherein said cytokine or lymphokine is a feline cytokine or lymphokine.  
     
     
         25 . The method according to  claim 1 , wherein said immunogen is administered in combination with interleukin-12, interleukin-15, or interleukin-18.  
     
     
         26 . The method according to  claim 1 , wherein said immunogen comprises an immunogenic or antigenic peptide of a primate immunodeficiency virus protein.  
     
     
         27 . The method according to  claim 1 , wherein said immunogen induces the production of T-helper cytokines and cytotoxic T lymphocyte (CTL) cytotoxins.  
     
     
         28 . A method for inhibiting or generating an immune response in a feline animal against FIV, said method comprising administering to said animal an effective amount of an immunogen derived from a primate immunodeficiency virus.  
     
     
         29 . A method for screening for an epitope of a viral protein that is evolutionarily conserved between HIV and FIV, said method comprising: 
 a) isolating of HIV from a long term non-progressor patient infected with said HIV;    b) immunizing a feline animal with an immunogen derived from said HIV;    c) challenging said feline animal with an infectious FIV; and    d) determining whether said feline animal is protected from infection by said FIV, wherein an immunogen that protects said feline animal from infection is indicative of an immunogen that comprises an epitope or epitopes evolutionarily conserved between said HIV and said FIV.    
     
     
         30 . A composition comprising an immunogen derived from a primate immunodeficiency virus and a feline cytokine or lymphokine.  
     
     
         31 . The composition according to  claim 30 , wherein said feline lymphokine is an interleukin.  
     
     
         32 . The composition according to  claim 31 , wherein said interleukin is selected from the group consisting of IL-1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-11, IL-12, IL-13, IL-14, IL-15, IL-16, IL-17, IL-18, IL-19, IL-20, IL-21, and IL-22.  
     
     
         33 . The composition according to  claim 31 , wherein said interleukin is selected from the group consisting of IL-12, IL-15, and IL-18.  
     
     
         34 . The composition according to  claim 31 , wherein said primate immunodeficiency virus is HIV or FIV.  
     
     
         35 . The composition according to  claim 34 , wherein said HIV is HIV-1 or HIV-2.  
     
     
         36 . The composition according to  claim 35 , wherein said HIV-1 virus is selected from the group consisting of HIV-1 IIIB , HIV-1 UCD1 , and HIV-1 BRU .  
     
     
         37 . The composition according to  claim 31 , wherein said immunogen comprises a polynucleotide sequence of an env, pol, gag, tat, rev, vif, vpr, vpu, vpx, or nef gene of HIV.  
     
     
         38 . The composition according to  claim 31 , wherein said immunogen comprises a gp160, gp120, gp41, p31, p24, p17, or p7 polypeptide, or an immunogenic fragment thereof, of HIV.  
     
     
         39 . The composition according to  claim 31 , wherein said immunogen is an HIV p24 polypeptide, or an immunogenic fragment thereof, and said interleukin is selected from the group consisting of feline IL-12, IL-15, and IL-18.  
     
     
         40 . A kit comprising in one or more containers: 
 a) an immunogen derived from a primate immunodeficiency virus; and    b) a feline cytokine or lymphokine.    
     
     
         41 . The kit according to  claim 40 , wherein said feline lymphokine is an interleukin.  
     
     
         42 . The kit according to  claim 40 , wherein said interleukin is selected from the group consisting of IL-1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-11, IL-12, IL-13, IL-14, IL-15, IL-16, IL-17, IL-18, IL-19, IL-20, IL-21, and IL-22.  
     
     
         43 . The kit according to  claim 40 , wherein said interleukin is selected from the group consisting of IL-12, IL-15, and IL-18.  
     
     
         44 . The kit according to  claim 40 , wherein said primate immunodeficiency virus is HIV or FIV.  
     
     
         45 . The kit according to  claim 44 , wherein said HIV is HIV-1 or HIV-2.  
     
     
         46 . The kit according to  claim 45 , wherein said HIV-1 virus is selected from the group consisting of HIV-1 IIIB , HIV-1 UCD1 , and HIV-1 BRU .  
     
     
         47 . The kit according to  claim 40 , wherein said immunogen comprises a polynucleotide sequence of an env, pol, gag, tat, rev, vif, vpr, vpu, vpx, or nef gene of HIV.  
     
     
         48 . The kit according to  claim 40 , wherein said immunogen comprises a gp160, gp120, gp41, p31, p24, p17, or p7 polypeptide, or an immunogenic fragment thereof, of HIV.  
     
     
         49 . The kit according to  claim 40 , wherein said immunogen is an HIV p24 polypeptide, or an immunogenic fragment thereof, and said interleukin is selected from the group consisting of feline IL-12, IL-15, and IL-18.  
     
     
         50 . The method according to  claim 28 , wherein said immunogen induces the production of T-helper cytokines and cytotoxic T lymphocyte (CTL) cytotoxins.  
     
     
         51 . The method according to  claim 28 , wherein said immune response is a cellular immune response.  
     
     
         52 . The method according to  claim 28 , wherein said immune response is a humoral immune response.