New vaccine formulations

Abstract

The present invention provides for a novel oil-in-water (O/W) emulsion, with increased stability in the presence of bacterial or viral suspensions, especially those concentrated and non-purified or weakly purified. The emulsion of the present invention can act as vehicle for the delivery of a pharmaceutical composition comprising at least one immunogen and, in particular, an immunogen selected from the group comprising an inactivated pathogen, an attenuated pathogen, a subunit, a recombinant expression vector, and a plasmid or combinations thereof. In one embodiment, the present invention provides for an injectable oil-in-water (O/W) emulsion comprising: (1) an aqueous solution containing an immunogen, said immunogen selected from the group comprising an inactivated Mycoplasma hyopneumoniae bacterium, an inactivated porcine circovirus type 2 (PCV-2) virus or combinations thereof; (2) a mineral oil; (3) a non-ionic lipophilic surfactant; and (4) a non-ionic hydrophilic surfactant having a low HLB value which comprises ethoxylated fatty acid diesters of sorbitan (generally having HLB value between 11 and 13).

1 - 35 . (canceled) 
   
   
       36 . A method for preparing a novel vaccine formulation comprising the steps of:
 a) adding about one volume of oily phase to an emulsifier means,   b) rotating said emulsifier means from about 4000 rpm to about 6000 rpm,   c) adding about one volume of a first aqueous phase to the about one volume of oily phase to said emulsifier means while continuing to rotate said emulsifier means from about 30 seconds to about 2 minutes,   d) stopping rotation of said emulsifier means,   e) placing a resulting emulsion produced by said rotating at 5° C. for at least 4 hours,   f) adding about one volume of a second aqueous phase at about 5° C. to about one volume of said resulting emulsion at about 5° C. and stirring for about 1 minute;   wherein said oily phase comprises more than one surfactant; and   wherein said second aqueous phase comprises at least one immunogen; and   wherein the total weight of said more than one surfactant is about 0.75% to about 5.5% (w/v) of said novel vaccine formulation.   
   
   
       37 . The method of  claim 36 , wherein said immunogen is selected from the group consisting of  Salmonella typhimurium, Salmonella enteritidis , Infectious Bronchitis virus (IBV), Newcastle Disease virus (NDV), egg drop syndrome virus (EDS), or Infectious Bursal Disease virus (IBDV), and avian influenza virus. 
   
   
       38 . The method of  claim 36  wherein said at least one immunogen is selected from the group consisting of feline herpesvirus (FHV), feline calicivirus (FCV), feline leukemia virus (FeLV), and feline immunodeficiency virus (FIV). 
   
   
       39 . The method of  claim 36  wherein said at least one immunogen is selected from the group consisting of rabies virus, canine herpesvirus (CHV), canine parvovirus (CPV), canine coronavirus,  Leptospira canicola, Leptospira icterohaemorragiae, Leptospira grippotyphosa, Borrelia burgdorferi , and  Bordetella bronchiseptica.    
   
   
       40 . The method of  claim 36  wherein said at least one immunogen is selected from the group consisting of equine herpesvirus (type 1 or type 4), equine influenza virus, tetanus, and west nile virus. 
   
   
       41 . The method of  claim 36  wherein said at least one immunogen is selected from the group consisting of swine influenza virus (SIV), porcine circovirus type 2 (PCV-2), porcine reproductive respiratory syndrome virus (PRRS), pseudorabies virus (PRV), porcine parvovirus (PPV),  Mycoplasma hyopneumoniae, Erysipelothrix rhusiopathiae, Pasteurella multocida, Bordetella bronchiseptica , and  Escherichia coli.    
   
   
       42 . The method of  claim 36  wherein said at least one immunogen is selected from the group consisting of bovine rotavirus, bovine parainfluenza virus type 3 (bPIV-3), bovine coronavirus, bovine viral diarrhea virus (BVDV), bovine respiratory syncytial virus (BRSV), Infectious Bovine Rhinotracheitis virus (IBR),  Escherichia coli, Pasteurella multocida , and  Pasteurella haemolytica.    
   
   
       43 . The method of  claim 36  wherein said at least one immunogen is inactivated  Mycoplasma hyopneumoniae  or inactivated PCV-2. 
   
   
       44 . The method of  claim 36  wherein said at least one immunogen is inactivated  Mannheimia haemolytica.