ES2569063T3 - Vacuna combinada contra Mycoplasma hyopneumoniae y circovirus porcino - Google Patents

Vacuna combinada contra Mycoplasma hyopneumoniae y circovirus porcino Download PDF

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Publication number
ES2569063T3
ES2569063T3 ES07019279.4T ES07019279T ES2569063T3 ES 2569063 T3 ES2569063 T3 ES 2569063T3 ES 07019279 T ES07019279 T ES 07019279T ES 2569063 T3 ES2569063 T3 ES 2569063T3
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Prior art keywords
mycoplasma hyopneumoniae
pigs
porcine circovirus
provocation
vaccine against
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Expired - Lifetime
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ES07019279.4T
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Inventor
Hsien-Jue Chu
Wumin Li
Zhichang Xu
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Zoetis Services LLC
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Zoetis Services LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/295—Polyvalent viral antigens; Mixtures of viral and bacterial antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/0241—Mollicutes, e.g. Mycoplasma, Erysipelothrix
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
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    • A61P31/04—Antibacterial agents
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/52—Bacterial cells; Fungal cells; Protozoal cells
    • A61K2039/521—Bacterial cells; Fungal cells; Protozoal cells inactivated (killed)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • A61K2039/552—Veterinary vaccine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55566—Emulsions, e.g. Freund's adjuvant, MF59
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
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  • Microbiology (AREA)
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  • Engineering & Computer Science (AREA)
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  • Pulmonology (AREA)
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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Una composición de vacuna para inmunizar un animal contra infección por Mycoplasma hyopneumoniae y circovirus porcino (PCV) que comprende una cantidad inmunizante de bacterina de Mycoplasma hyopneumoniae; una cantidad inmunizante de circovirus porcino (PCV); una mezcla de adyuvantes que comprende un polímero de ácido acrílico y una mezcla de un aceite metabolizable y un copolímero en bloque de polioxietileno-polioxipropileno; y un vehículo farmacéuticamente aceptable composición de vacuna que después de una administración única provoca inmunidad protectora contra Mycoplasma hyopneumoniae.

Description

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Vacuna de prueba A
Cantidades para 1.000.000 dosis (2 ml cada una):
% en vol/vol
Concentrado de Mycoplasma (>1,0 x 1010 MHDCE/ml)
1200.000 ml 60,0
Mezcla de escualano/Pluronic L121
200.000 ml 10,0
Carbopol (2 % en peso/volumen en agua)
200.000 ml 10,0
Disolución de timerosal al 1 % en peso/volumen en agua y EDTA (sal tetrasódica) al 7 % en peso/volumen
18.000 ml 0,9
Solución salina estéril
382.000 ml 19,1
El pH de la serie se ajusta a 7,0 ± 0,2. MHDCE = equivalentes celulares de ADN de Mycoplasma hyopneumoniae
Resumen
En esta evaluación se enrolaron treinta y tres cerdos de 21 días. Veinte cerdos se vacunaron con una dosis de vacuna A intramuscularmente (IM) a la edad de tres semanas. Diez cerdos sirvieron de controles no vacunados y tres cerdos de controles ambientales de no provocación.
Todos los cerdos fueron seronegativos (título de anticuerpos <10) en el momento de la vacunación, lo que indica que los animales eran sensibles a M. hyopneumoniae. Todos los cerdos en los grupos de control siguieron siendo seronegativos antes de la provocación. Esto indica que la respuesta inmunitaria en los cerdos vacunados fue debida a la vacuna y no a cualquier exposición ambiental.
Seis meses tras la vacunación, 20 cerdos vacunados y 10 cerdos de control no vacunados se provocaron con M. hyopneumoniae virulenta (1,0 x 106 organismos por cerdo). Tres cerdos sirvieron de controles no expuestos. Los cerdos vacunados tuvieron una puntuación de lesiones pulmonares promedio del 3,6 % y los cerdos de control expuestos tuvieron una puntuación de lesiones pulmonares promedio del 14,6 %. Las lesiones pulmonares en el grupo vacunado fueron significativamente inferiores a las de los controles (p=0,0215).
Los datos obtenidos en esta evaluación demuestran que la vacuna de prueba A indujo inmunidad protectora a largo plazo contra la provocación con M. hyopneumoniae virulenta seis meses después de una vacunación de dosis única.
Diseño experimental
Treinta y tres cerdos de 21 días se asignaron al azar a tres grupos (grupo vacunado, grupo de control de la provocación y grupo de control ambiental de no provocación) usando el programa de aleatorización Microsoft Excel por camada. Veinte cerdos se vacunaron con una dosis de vacuna de prueba A intramuscularmente a la edad de tres semanas. Diez cerdos sirvieron de controles de la provocación y tres cerdos de controles ambientales de no provocación. Los cerdos en el grupo vacunado y los controles de la provocación se provocaron con 10 ml de un cultivo de M. hyopneumoniae (1,0 x 106 organismos) virulenta por cerdo seis meses después de la vacunación. Tres cerdos no vacunados se usaron como controles de no provocación. Los cerdos provocados y los controles de no provocación se sacrificaron 26 días después de la provocación y las lesiones pulmonares se puntuaron para cada cerdo.
Cada cerdo en los grupos de vacunación se administró con una dosis de 2 ml de la vacuna de prueba IM en el costado del cuello.
Provocación y autopsia
La disolución madre de provocación de M. hyopneumoniae virulenta, un homogeneizado de pulmón congelado (≤-70 ºC), se preparó por la Dra. Eileen Thacker de la Universidad del Estado de Iowa (ISU).
Se confirmó que la disolución madre de provocación era pura y que contenía aproximadamente 107 organismos de M. hyopneumoniae por ml.
Los cerdos se provocaron con 10 ml de una dilución 1:100 de la disolución madre (es decir, aproximadamente 1,0 x106 organismos).
El día de la provocación, el homogeneizado se descongeló rápidamente en agua caliente y se diluyó según
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Claims (1)

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ES07019279.4T 2002-05-17 2003-05-14 Vacuna combinada contra Mycoplasma hyopneumoniae y circovirus porcino Expired - Lifetime ES2569063T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US150597 2002-05-17
US10/150,597 US7018638B2 (en) 2000-12-19 2002-05-17 Mycoplasma hyopneumoniae bacterin vaccine

Publications (1)

Publication Number Publication Date
ES2569063T3 true ES2569063T3 (es) 2016-05-06

Family

ID=32680190

Family Applications (2)

Application Number Title Priority Date Filing Date
ES03813041T Expired - Lifetime ES2431988T3 (es) 2002-05-17 2003-05-14 Vacuna combinada mejorada contra Mycoplasma hyopneumoniae y virus porcinos
ES07019279.4T Expired - Lifetime ES2569063T3 (es) 2002-05-17 2003-05-14 Vacuna combinada contra Mycoplasma hyopneumoniae y circovirus porcino

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Application Number Title Priority Date Filing Date
ES03813041T Expired - Lifetime ES2431988T3 (es) 2002-05-17 2003-05-14 Vacuna combinada mejorada contra Mycoplasma hyopneumoniae y virus porcinos

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US (4) US7018638B2 (es)
EP (2) EP1506006B1 (es)
JP (2) JP2006515304A (es)
KR (1) KR101056622B1 (es)
CN (1) CN1305524C (es)
AR (1) AR039545A1 (es)
AU (1) AU2003303129B2 (es)
BR (1) BR0310082A (es)
CL (1) CL2010000397A1 (es)
DK (1) DK1870109T3 (es)
ES (2) ES2431988T3 (es)
HK (1) HK1111103A1 (es)
HR (1) HRP20041068B1 (es)
ME (1) ME00569B (es)
MX (1) MXPA04011218A (es)
NZ (1) NZ537014A (es)
RS (1) RS54390B1 (es)
TW (1) TWI320715B (es)
WO (1) WO2004058142A2 (es)
ZA (1) ZA200410153B (es)

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