Mycoplasma hyopneumoniae bacterin vaccine

Abstract

The invention provides an improved Mycoplasma hyopneumoniae bacterin vaccine composition, which advantageously provides immunity from infection after a single administration. The composition comprises an inactivated Mycoplasma hyopneumoniae bacterin and an adjuvant mixture, which, in combination, provide immunity from Mycoplasma hyopneumoniae infection after a single administration, and elicit an immune response specific to Mycoplasma hyopneumoniae bacterin and including cell-mediated immunity and local (secretory IgA) immunity. In a preferred embodiment, the adjuvant mixture comprises an acrylic acid polymer, most preferably Carbopol, and a mixture of a metabolizable oil such as one or more unsaturated terpene hydrocarbons, preferably squalene or squalane, and a polyoxyethylene-polypropylene block copolymer such as Pluronic®. The vaccine composition may optionally include a preservative, preferably thimerosol and/or EDTA.

What is claimed is:  
     
         1 . A vaccine composition for immunizing an animal against infection by  Mycoplasma hyopneumoniae  which comprises 
 an immunizing amount of  Mycoplasma hyopneumoniae  bacterin;    an adjuvant mixture comprising an acrylic acid polymer and a mixture of a metabolizable oil and a polyoxyethylene-polypropylene block copolymer; and    a pharmaceutically acceptable carrier which vaccine composition after a single administration elicits protective immunity from  Mycoplasma hyopneumoniae.      
     
     
         2 . The vaccine composition of  claim 1 , wherein the adjuvant mixture consists of an acrylic acid polymer and a mixture of a metabolizable oil that comprises one or more terpene hydrocarbons and a polyoxyethylene-polypropylene block copolymer in a ratio of about 1:25 to 1:50 of acrylic acid polymer to metabolizable oil/polyoxyethylene-polypropylene block copolymer mixture.  
     
     
         3 . The vaccine composition of  claim 1  wherein the adjuvant mixture comprises about 1-25% v/v of the vaccine composition.  
     
     
         4 . The vaccine composition of  claim 3  wherein the acrylic acid polymer is present in a final concentration of about 1% v/v and the terpene hydrocarbons/polyoxyethylene-polypropylene block copolymer mixture is present in a final concentration of about 5% to 10% v/v.  
     
     
         5 . The vaccine composition of  claim 3 , wherein the adjuvant mixture comprises about 2%-15% v/v of the vaccine composition.  
     
     
         6 . The vaccine composition of  claim 5 , wherein the adjuvant mixture comprises about 5%-12% v/v of the vaccine composition.  
     
     
         7 . The vaccine composition of  claim 1 , wherein the metabolizable oil is squalane or squalene.  
     
     
         8 . The vaccine composition of  claim 6  or  claim 7 , wherein the acrylic acid polymer is Carbopol.  
     
     
         9 . The vaccine composition of any of claims  1 - 8 , further comprising at least one bacterin selected from the group consisting of  Haemonphilus parasuis, Pasteurella multiocida, Streptococcum suis, Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Salmonella choleraesuis  and leptospira bacteria.  
     
     
         10 . A method for protecting an animal against disease caused by  Mycoplasma hyopneumoniae  comprising the step of administering to said animal a vaccine composition which comprises 
 an immunizing amount of a  Mycoplasma hyopneumoniae  bacterin;    an adjuvant mixture comprising an acrylic acid polymer and a mixture of metabolizable oil and a polyoxyethylene-polypropylene block copolymer; and    a pharmaceutical acceptable carrier which vaccine composition, after a single administration elicits protective immunity from  Mycoplasma hyopneumoniae  infection.    
     
     
         11 . The method of  claim 10 , wherein the immunizing amount of said bacteria is about 1×10 8  to 3×10 11  MHDCE/mL.  
     
     
         12 . The method according to  claim 11  wherein the immunizing amount of said bacteria is about 1×10 9  to 3×10 9  MHDCE/mL.  
     
     
         13 . The method of  claim 10 , wherein the mode of administration of said administering step is intramuscular, subcutaneous, intraperitoneal, aerosol, oral or intranasal.  
     
     
         14 . The method of  claim 10 , wherein the adjuvant mixture consists of an acrylic acid polymer and a mixture of metabolizable oil that comprises one or more terpene hydrocarbons and a polyoxyethylene-polypropylene block copolymer present in a final concentration of about 1-25% v/v.  
     
     
         15 . The method of  claim 14 , wherein the acrylic acid polymer of the adjuvant mixture is Carbopol.  
     
     
         16 . The method of  claim 14 , wherein the metabolizable oil of the adjuvant mixture is a terpene hydrocarbon selected from the group of squalene and squalane.  
     
     
         17 . The method of any claims  10 - 16 , further comprising coadministering at least one additional bacterin selected from the group consisting of  Haemonphilus parasuis; Pasteurella multiocida; Streptococcum suis; Actinobacillus pleuropneumoniae; Bordetella bronchiseptica; Salmonella choleraesuis;  and leptospira bacteria.  
     
     
         18 . A vaccine comprising inactivated  Mycoplasma hyopneumoniae,  a metabolizable oil, a polyoxyethylene-polyproplyene block copolymer and an acrylic acid polymer in the form of an oil in water emulsion.