DK2371385T3 - Anvendelse af en PV2-immunogen sammensætning til mindskning af kliniske symptomer i grise - Google Patents

Anvendelse af en PV2-immunogen sammensætning til mindskning af kliniske symptomer i grise Download PDF

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DK2371385T3
DK2371385T3 DK11164854.9T DK11164854T DK2371385T3 DK 2371385 T3 DK2371385 T3 DK 2371385T3 DK 11164854 T DK11164854 T DK 11164854T DK 2371385 T3 DK2371385 T3 DK 2371385T3
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Michael B Roof
Marc Allan Eichmeyer
Greg Nitzel
Phillip Wayne Hayes
Merrill Lynn Schaeffer
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Boehringer Ingelheim Vetmed
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Claims (30)

1. Immunogen sammensætning i stand til at frembringe eller øge et immunrespons mod PCV2, og som omfatter rekombinant fremstillet PCV2-ORF2-protein til anvendelse i forebyggelse af lymfadenopati i kombination med ét eller flere af de følgende symptomer i grise: (1) interstitiel pneumoni med interlobulær ødem, (2) kutan bleghed eller ikterus, (3) brogede atrofiske levere (ENG: mottled atrophic livers), (4) mavesår og (5) nefritis, hvor PCV2-ORF2-proteinet er til indgivelse én gang til grise.
2. Immunogen sammensætning ifølge krav 1 til anvendelse ifølge krav 1, hvor det rekombinant fremstillede PCV2-ORF2-protein er baculovirus udtrykt PCV2-ORF2-protein.
3. Immunogen sammensætning ifølge krav 1 eller 2 til anvendelse ifølge krav 1 eller krav 2, hvor det rekombinant fremstillede PCV2-ORF2-protein er blevet tilvejebragt ved en fremgangsmåde, hvor - modtagelige celler inficeres med en rekombinant baculovirusvektor, som indeholder PCV2-ORF2-DNA-kodende sekvenser, - PCV2-ORF2-polypeptid udtrykkes af den rekombinante baculovirus, og - det udtrykte PCV2-ORF2-polypeptid indvindes fra supernatanten ved filtrering og inaktiveres.
4. Immunogen sammensætning ifølge et hvilket som helst af krav 1 til 3 til anvendelse ifølge et hvilket som helst af krav 1 til 3, hvor det rekombinant fremstillede PCV2-ORF2-protein er blevet indvundet fra supernatanten af in vitro-dyrkede celler, hvor cellerne blev inficeret med en rekombinant baculovirus vektor, som indeholder PCV2-ORF2-DNA og udtrykte PCV2-ORF2-protein, og hvor cellekulturen blev behandlet med omkring 2 til omkring 8 mM BEI for at inaktivere baculovirusvektoren, og en ækvivalent koncentration af et neutraliseringsmiddel.
5. Immunogen sammensætning ifølge et hvilket som helst af krav 1 til 4 til anvendelse ifølge et hvilket som helst af krav 1 til 4, yderligere omfattende mindst en del af rekombinant baculovirusvektor, der udtrykker PCV2-ORF2-proteinet.
6. Immunogen sammensætning ifølge krav 5 til anvendelse ifølge krav 5, yderligere omfattende en del af cellekultursupernatant.
7. Immunogen sammensætning ifølge et hvilket som helst af krav 1 til 6 til anvendelse ifølge et hvilket som helst af krav 1 til 6, hvor den immunogene sammensætning er en vaccine.
8. Immunogen sammensætning ifølge et hvilket som helst af krav 1 til 7 til anvendelse ifølge et hvilket som helst af krav 1 til 7, som omfatter fra omkring 0,3 til omkring 200 pg af det rekombinant fremstillede PCV2-ORF2-protein per dosis.
9. Immunogen sammensætning ifølge et hvilket som helst af krav 1 til 8 til anvendelse ifølge et hvilket som helst af krav 1 til 8, hvor grisene er grise der er 2 uger garn- le eller ældre, men ikke ældre end 15 uger gamle.
10. Immunogen sammensætning ifølge et hvilket som helst af krav 1 til 9 til anvendelse ifølge et hvilket som helst af krav 1 til 9, hvor den immunogene sammensætning yderligere omfatter et adjuvans.
11. Immunogen sammensætning ifølge krav 10 til anvendelse ifølge krav 10, hvor adjuvanset kan indbefatte aluminiumhydroxid og aluminiumphosphat, saponiner, vand-i-olie-emulsion, olie-i-vand-emulsion, vand-i-olie-i-vand-emulsion eller, hvor adjuvanset er en forbindelse valgt blandt polymererne af acryl- eller methacrylsyre og copolymererne af maleinanhydrid og alkenylderivat.
12. Immunogen sammensætning ifølge krav 10 eller 11 til anvendelse ifølge krav 10 eller 11, som omfatter 100 pg til 10 mg af adjuvanset per dosis.
13. Immunogen sammensætning ifølge et hvilket som helst af krav 1 til 12 til anvendelse ifølge et hvilket som helst af krav 1 til 12, hvor den immunogene sammensætning er i alt væsentligt fri af antigener eller polypeptider fra PCV2 bortset fra PCV2-ORF2-protein.
14. Immunogen sammensætning ifølge krav 4 til anvendelse ifølge krav 4 og yderligere omfattende et adjuvans anført i krav 11, hvor den immunogene sammensætning er stabil over en periode på 24 måneder.
15. Immunogen sammensætning ifølge et hvilket som helst af krav 1 til 14 til anvendelse ifølge et hvilket som helst af krav 1 til 14, hvor lægemidlet er til indgivelse intra-muskulært.
16. Anvendelse af en immunogen sammensætning i stand til at frembringe eller øge et immunrespons mod PCV2, og som omfatter rekombinant fremstillet PCV2-ORF2-protein til fremstilling af et lægemiddel til forebyggelse af lymfadenopati i kombination med ét eller flere af de følgende symptomer i grise: (1) interstitiel pneumoni med interlobulær ødem, (2) kutan bleghed eller ikterus, (3) brogede atrofiske levere (ENG: mottled atrophic livers), (4) mavesår og (5) nefritis, hvor PCV2-ORF2-proteinet er til indgivelse én gang til grise.
17. Anvendelse ifølge krav 16, hvor det rekombinant fremstillede PCV2-ORF2-protein er baculovirus-udtykt PCV2-ORF2-protein.
18. Anvendelse ifølge krav 16 eller 17, hvor det rekombinant fremstillede PCV2-ORF2-protein er blevet tilvejebragt ved en fremgangsmåde, hvor - modtagelige celler inficeres med en rekombinant baculovirusvektor, som indeholder PCV2-ORF2-DNA-kodende sekvenser, - PCV2-ORF2-polypeptid udtrykkes af den rekombinante baculovirus, og - det udtrykte PCV2-ORF2-polypeptid indvindes fra supernatanten ved filtrering og inaktiveres.
19. Anvendelse ifølge et hvilket som helst af krav 16 til 18, hvor det rekombinant fremstillede PCV2-ORF2-protein er blevet indvundet fra supernatanten af in w'tro-dyrkede celler, hvor cellerne blev inficeret med en rekombinant baculovirus vektor, som indeholder PCV2-ORF2-DNA og udtrykte PCV2-ORF2-protein, og hvor cellekulturen blev behandlet med omkring 2 til omkring 8 mM BEI for at inaktivere baculovirusvektoren, og en ækvivalent koncentration af et neutraliseringsmiddel.
20. Anvendelse ifølge et hvilket som helst af krav 16 til 19, hvor sammensætningen yderligere omfatter mindst en del af rekombinant baculovirusvektor, der udtrykker PCV2-ORF2-protein.
21. Anvendelse ifølge krav 20, hvor sammensætningen yderligere omfattende en del af cellekultursupernatant.
22. Anvendelse ifølge et hvilket som helst af krav 16 til 21, hvor den immunogene sammensætning er en vaccine.
23. Anvendelse ifølge et hvilket som helst af krav 16 til 22, hvor sammensætningen omfattende fra omkring 0,3 til omkring 200 pg af det rekombinant fremstillede PCV2-ORF2-protein per dosis.
24. Anvendelse ifølge et hvilket som helst af krav 16 til 23, hvor grisene er grise, der er 2 uger gamle eller ældre, men ikke ældre end 15 uger gamle.
25. Anvendelse ifølge et hvilket som helst af krav 16 til 24, hvor den immunogene sammensætning yderligere omfatter et adjuvans.
26. Anvendelse ifølge krav 25, hvor adjuvanset kan indbefatte aluminiumhydroxid og aluminiumphosphat, saponiner, vand-i-olie-emulsion, olie-i-vand-emulsion, vand-i-olie-i-vand-emulsion eller, hvor adjuvanset er en forbindelse valgt blandt polymererne af acryl- eller methacrylsyre og copolymererne af maleinanhydrid og alkenylderivat.
27. Anvendelse ifølge krav 25 eller 26, hvor sammensætningen omfatter 100 pg til 10 mg af adjuvans per dosis.
28. Anvendelse ifølge et hvilket som helst af krav 16 til 27, hvor den immunogene sammensætning er i alt væsentligt fri af antigener eller polypeptider fra PCV2 bortset fra PCV2-ORF2-protein.
29. Anvendelse ifølge krav 19, hvor den immunogene sammensætning yderligere omfatter et adjuvans anført i krav 26 og er stabil over en periode på 24 måneder.
30. Anvendelse ifølge et hvilket som helst af krav 16 til 29, hvor lægemidlet er til indgivelse intramuskulært.
DK11164854.9T 2005-12-29 2006-12-28 Anvendelse af en PV2-immunogen sammensætning til mindskning af kliniske symptomer i grise DK2371385T3 (da)

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