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Publication Number
US-9956279-B2
Publication Date
2018-05-01
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 disclosed invention relates to a multivalent vaccine formulation for pigs that is premixed and ready-to-use, comprising recombinant porcine circovirus type 2 (PCV2) ORF2 capsid antigen together with a Mycoplasma hyopneumoniae antigen. The vaccine includes a physiologically acceptable vehicle and is administered as a single dose to reduce PCV2 infection and to elicit immune responses to PCV2 and Mycoplasma hyopneumoniae.
The PCV2 ORF2 capsid antigen is quantified in ELISA units using PCV2-Ag-51811 as the reference antigen. The Mycoplasma hyopneumoniae antigen is provided as an inactivated/attenuated antigen or as a lysate/sonicate of Mycoplasma hyopneumoniae, and the formulation includes a specific two-component adjuvant system.
The two-component adjuvant system includes a first component comprising a saponin adjuvant and a second component comprising either an oil-in-water adjuvant or an aluminum adjuvant, formulated in a manner suitable for a ready-to-use single-dose product. The disclosure also states that single-dose administration in piglets supports reduced PCV2-associated outcomes and reduced Mycoplasma hyopneumoniae lung pathology after challenge.
Claims Coverage
The partial content provides two independent claims. Across the independent claims, the main inventive features are the multivalent vaccine composition with recombinant PCV2 ORF2 capsid antigen quantified by PCV2-Ag-51811, Mycoplasma hyopneumoniae antigen, and a two-component adjuvant system in a physiologically acceptable vehicle, used for reducing PCV2 infection or eliciting immune response within an early-life window.
Single-dose reduction of PCV2 infection using a specified multivalent vaccine
A method of reducing PCV2 infection in a pig comprising administering a single dose of a multivalent vaccine comprising at least 1 ELISA unit of recombinant PCV2 ORF2 capsid antigen determined by PCV2-Ag-51811 as the reference antigen, at least 60 micrograms of Mycoplasma hyopneumoniae antigen, a two-component adjuvant system with a first component comprising a saponin adjuvant and a second component comprising an oil-in-water adjuvant or aluminum adjuvant, and a physiologically acceptable vehicle.
Single-dose elicitation of immune response to PCV2 and Mycoplasma hyopneumoniae within an early-life window
A method of eliciting an immune response to PCV2 and Mycoplasma hyopneumoniae in a pig comprising administering a single dose of a multivalent vaccine within 1 to weeks of birth, the vaccine comprising at least 1 ELISA unit of recombinant PCV2 ORF2 capsid antigen determined by PCV2-Ag-51811 as the reference antigen, 60-180 micrograms of Mycoplasma hyopneumoniae antigen, a two-component adjuvant system with a first component comprising a saponin adjuvant and a second component comprising an oil-in-water adjuvant or aluminum adjuvant, and a physiologically acceptable vehicle.
The claim coverage centers on a single-dose multivalent vaccine for pigs with recombinant PCV2 ORF2 capsid antigen quantified by PCV2-Ag-51811 together with Mycoplasma hyopneumoniae antigen, formulated with a two-component adjuvant system consisting of a saponin component and an oil-in-water or aluminum component in a physiologically acceptable vehicle.
Stated Advantages
Reduces/prevents PCV2 viremia after challenge.
Reduces PCV2 colonization of lymphoid tissues and associated lymphoid depletion.
Reduces PCV2-associated clinical signs and associated gross and IHC findings.
Reduces lung lesions and Mycoplasma hyopneumoniae lung pathology/lesion scores after challenge.
Documented Applications
A method of reducing PCV2 infection in pigs by administering a single dose of the multivalent vaccine.
A method of eliciting an immune response to PCV2 and Mycoplasma hyopneumoniae in pigs by administering a single dose of the multivalent vaccine within 1 to weeks of birth.
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