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Publication Number
US-9649370-B2
Publication Date
2017-05-16
Expiration Date
Abstract
A premixed multivalent vaccine in ready-to-use form comprising PCV2 ORF2 capsid antigen and M. hyopneumoniae antigen that reduces or prevents PCV2 infection and/or M. hyopneumoniae infection in pigs after a single dose administration of the vaccine is disclosed.
Core Innovation
The document describes a premixed ready-to-use multivalent single-dose pig vaccine. The vaccine includes a recombinant porcine circovirus type 2 (PCV2) ORF2 capsid antigen and a Mycoplasma hyopneumoniae antigen formulated for administration to pigs as a single dose.
The multivalent vaccine contains a two component adjuvant system together with a physiologically acceptable vehicle. The first component comprises a saponin adjuvant, and the second component comprises either an oil-in-water adjuvant or an aluminum adjuvant.
The vaccine is described as prepared and formulated as a ready-to-use (RTU) single-dose composition. The document presents experimental efficacy results showing that a single dose reduces or prevents PCV2 viremia and related colonization, depletion, clinical signs, and pathology, and reduces M. hyopneumoniae lung lesions and PCR-detected infection after challenge.
Claims Coverage
The document contains a single independent claim. The inventive features focus on the multivalent single-dose vaccine composition, including quantified recombinant PCV2 ORF2 capsid antigen defined by ELISA units using PCV2-Ag-5181, a defined amount range of M. hyopneumoniae antigen per dose, and a two component adjuvant system combining saponin with either an oil-in-water adjuvant or an aluminum adjuvant in a physiologically acceptable vehicle.
Multivalent single-dose vaccine composition with defined PCV2 ORF2 capsid antigen by ELISA reference
A multivalent single dose vaccine comprising at least 1 ELISA unit of recombinant PCV2 ORF2 capsid antigen per dose, wherein the ELISA unit is determined by PCV2-Ag-5181 as a reference antigen.
Defined Mycoplasma hyopneumoniae antigen amount per dose
60-180 micrograms of Mycoplasma hyopneumoniae antigen per dose.
Two component adjuvant system with saponin plus oil-in-water or aluminum
a two component adjuvant system, the first component comprising a saponin adjuvant and the second component comprising an oil-in-water adjuvant or aluminum adjuvant.
Physiologically acceptable vehicle for the vaccine
a physiologically acceptable vehicle.
Overall, the claim coverage is directed to a multivalent single-dose vaccine defined by ELISA-unit quantification of recombinant PCV2 ORF2 capsid antigen using PCV2-Ag-5181, a specific microgram range for M. hyopneumoniae antigen per dose, a two component adjuvant system combining a saponin adjuvant with either an oil-in-water adjuvant or an aluminum adjuvant, and formulation in a physiologically acceptable vehicle.
Stated Advantages
Reduces or prevents PCV2 viremia following challenge.
Reduces or prevents PCV2 colonization of lymphoid tissues following challenge.
Reduces or prevents lymphoid depletion associated with PCV2.
Reduces PCV2-associated clinical signs and PCV2-associated pathology.
Reduces M. hyopneumoniae lung lesions following challenge.
Reduces PCR-detected infection of M. hyopneumoniae following challenge.
Documented Applications
Vaccination of pigs with a multivalent single-dose vaccine to reduce or prevent PCV2-related outcomes and to reduce M. hyopneumoniae lung lesions and PCR-detected infection after challenge with field strains.
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