Pcv2 mycoplasma hyopneumoniae immunogenic compositions and methods of producing such compositions

Abstract

Multivalent combination vaccines are provided which include an immunological agent effective for reducing the incidence of or lessening the severity of M. hyo infection, preferably M. hyo bacterin, or an immunogenic composition comprising M. hyo bacterin, and at least one immunogenic active component of another disease-causing organism in swine, preferably PCV2 wherein the preferred PCV2 antigen for such a multivalent vaccine is PCV2 ORF 2 protein.

1 . An immunogenic composition for eliciting a protective immune response in a pig against  Mycoplasma hyopneumoniae  (M. hyo) wherein said immunogenic composition comprises porcine circovirus type 2 antigen and M. hyo antigen, wherein the amount of the M. hyo antigen per dose has a relative potency (RP) value of at least 1.22, wherein an RP value of 1.22 for M. hyo means that 95% and preferably 100% of mice receiving an administration of one-fortieth ( 1/40) of such amount of M. hyo antigen develop a detectable amount of antibodies within or at 21 days post treatment in an M. hyo specific antibody detection assay. 
     
     
         2 . The immunogenic composition according to  claim 1 , wherein the amount of porcine circovirus type 2 antigen per dose has a relative potency (RP) value of at least 1.38, wherein an RP value of 1.38 for porcine circovirus type 2 antigen means that 95% and preferably 100% of mice receiving an administration of one-tenth ( 1/10) of such amount of porcine circovirus type 2 antigen develop a detectable amount of antibodies within 21 days post treatment in an porcine circovirus type 2 specific antibody detection assay. 
     
     
         3 . The immunogenic composition according to  claim 1 , wherein said composition further comprises an adjuvant. 
     
     
         4 . The immunogenic composition according to  claim 3 , wherein the adjuvant is a carbomer. 
     
     
         5 . The immunogenic composition according to  claim 4 , wherein said carbomer is Carbopol. 
     
     
         6 . The immunogenic composition according to  claim 1 , wherein said immunogenic composition elicits a protective immune response against M. hyo when administered to a pig as a single dose administration. 
     
     
         7 . The immunogenic composition according to  claim 2 , wherein said immunogenic composition elicits a protective immune response against M. hyo and porcine circovirus type 2 when administered to a pig as a single dose administration. 
     
     
         8 . The immunogenic composition according to  claim 1 , wherein the immunogenic composition elicits a duration of immunity against M. hyo and/or porcine circovirus type 2 of at least 130 days when administered to a pig. 
     
     
         9 . The immunogenic composition according to  claim 8 , wherein the immunogenic composition elicits a duration of immunity against M. hyo and/or porcine circovirus type 2 of at least 150 days when administered to a pig. 
     
     
         10 . The immunogenic composition according to  claim 8 , wherein the immunogenic composition elicits a duration of immunity against M. hyo and/or porcine circovirus type 2 of at least 184 days when administered to a pig. 
     
     
         11 . The immunogenic composition according to  claim 1 , wherein the specific antibody detection assay is an ELISA. 
     
     
         12 . The immunogenic composition according to  claim 1 , wherein the specific antibody detection assay for detecting the M. hyo specific antibodies is the IDEXX Herdchek M. hyo Test Kit. 
     
     
         13 . The immunogenic composition according to  claim 2 , wherein the specific antibody detection assay for detecting the porcine circovirus type 2 specific antibodies is the  modified indirect porcine circovirus  ( PCV )  type  2- based and recombinant capsid protein  ( ORF 2)- based ELISA for the detection of antibodies to PCV  as exemplarily described in Clin. Diagn. Lab. Immunol. 9:33-40 (2002). 
     
     
         14 . A method for eliciting a protective immune response in a pig against  Mycoplasma hyopneumoniae  (M. hyo) comprising administering to said pig an immunogenic composition which comprises porcine circovirus type 2 antigen and M. hyo antigen, wherein the amount of the M. hyo antigen per dose has a relative potency value of at least 1.22, wherein an RP value of 1.22 for M. hyo means that 95% and preferably 100% of mice receiving an administration of one-fortieth ( 1/40) of such amount of M. hyo antigen develop a detectable amount of antibodies within or at 21 days post treatment in an M. hyo specific antibody detection assay. 
     
     
         15 . The method of  claim 14 , wherein the amount of porcine circovirus type 2 antigen per dose has a relative potency (RP) value of at least 1.38, wherein an RP value of 1.38 for porcine circovirus type 2 antigen means that 95% and preferably 100% of mice receiving an administration of one-tenth ( 1/10) of such amount of porcine circovirus type 2 antigen develop a detectable amount of antibodies within 21 days post treatment in an porcine circovirus type 2 specific antibody detection assay. 
     
     
         16 . The method according to  claim 14 , wherein said composition further comprises an adjuvant. 
     
     
         17 . The method composition according to  claim 16 , wherein the adjuvant is a carbomer. 
     
     
         18 . The method according to  claim 17 , wherein said carbomer is Carbopol. 
     
     
         19 . The method according to  claim 14 , wherein said immunogenic composition elicits a protective immune response against M. hyo when administered to said pig as a single dose administration. 
     
     
         20 . The method according to  claim 14 , wherein said immunogenic composition elicits a protective immune response against M. hyo and porcine circovirus type 2 when administered to said pig as a single dose administration. 
     
     
         21 . The method according to  claim 14 , wherein the immunogenic composition elicits a duration of immunity against M. hyo and/or porcine circovirus type 2 of at least 130 days when administered to said pig. 
     
     
         22 . The method according to  claim 21 , wherein the immunogenic composition elicits a duration of immunity against M. hyo and/or porcine circovirus type 2 of at least 150 days when administered to said pig. 
     
     
         23 . The method according to  claim 21 , wherein the immunogenic composition elicits a duration of immunity against M. hyo and/or porcine circovirus type 2 of at least 184 days when administered to said pig. 
     
     
         24 . The method according to  claim 14 , wherein the specific antibody detection assay is an ELISA. 
     
     
         25 . The method according to  claim 14 , wherein the specific antibody detection assay is the IDEXX Herdchek M. hyo Test Kit. 
     
     
         26 . The method according to  claim 15 , wherein the specific antibody detection assay for detecting the porcine circovirus type 2 specific antibodies is the  modified indirect porcine circovirus  ( PCV )  type  2- based and recombinant capsid protein  ( ORF 2)- based ELISA for the detection of antibodies to PCV  as exemplarily described in Clin. Diagn. Lab. Immunol. 9:33-40 (2002).