DK3017827T3 - Pneumokok-polysaccharidkonjugat-vaccine - Google Patents

Pneumokok-polysaccharidkonjugat-vaccine Download PDF

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Publication number
DK3017827T3
DK3017827T3 DK15195398.1T DK15195398T DK3017827T3 DK 3017827 T3 DK3017827 T3 DK 3017827T3 DK 15195398 T DK15195398 T DK 15195398T DK 3017827 T3 DK3017827 T3 DK 3017827T3
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Prior art keywords
saccharide
protein
immunogenic composition
paragraph
vaccine
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DK15195398.1T
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English (en)
Inventor
Ralph Leon Biemans
Nathalie Marie-Josephe Garcon
Philippe Vincent Hermand
Jan Poolman
Mechelen Marcelle Paulette Van
Original Assignee
Glaxosmithkline Biologicals Sa
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Priority claimed from GB0526232A external-priority patent/GB0526232D0/en
Priority claimed from GBGB0607088.2A external-priority patent/GB0607088D0/en
Priority claimed from GB0607087A external-priority patent/GB0607087D0/en
Priority claimed from GB0609902A external-priority patent/GB0609902D0/en
Priority claimed from GB0620337A external-priority patent/GB0620337D0/en
Priority claimed from GBGB0620336.8A external-priority patent/GB0620336D0/en
Priority claimed from GB0620815A external-priority patent/GB0620815D0/en
Priority claimed from GB0620816A external-priority patent/GB0620816D0/en
Priority claimed from PCT/GB2006/004634 external-priority patent/WO2007068907A2/en
Application filed by Glaxosmithkline Biologicals Sa filed Critical Glaxosmithkline Biologicals Sa
Publication of DK3017827T3 publication Critical patent/DK3017827T3/da
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092—Streptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K39/12—Viral antigens
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/61—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
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    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
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    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
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    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
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    • A61K2039/6087—Polysaccharides; Lipopolysaccharides [LPS]
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    • 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
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Claims (13)

1. Immunogen sammensætning omfattende S. pneumoniae-kapselsaccharidkonjugater fra serotyper 19A og 19F, hvor 19A er konjugeret til et første bakterielt toxoid, som er pneumolysin, difteritoxoid eller CRM197, og 19F er konjugeret til et andet bakterielt toxoid, der er difteritoxoid eller CRM197, og yderligere omfattende kon-jugater af S. pneamon/'ae-kapselsaccharider 4, 6B, 9V, 14, 18C, 23F, 1, 5 og 7F, hvor gennemsnitsstørrelsen af 19A-saccharidet er mellem 110 og 700 kDa.
2. Immunogen sammensætning ifølge krav 1, der yderligere omfatter et konjugat af S. pneamon/'ae-kapselsaccharid 22F.
3. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor gennemsnitsstørrelsen af 19A-saccharidet er mellem 110-300, 120-200, 130-180 eller 140-160 kDa.
4. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor 19A-saccharidet er blevet dimensioneret med en faktor på ikke mere end x5.
5. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor 19A-saccharidet er blevet dimensioneret ved mikrofluidisering.
6. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor gennemsnitsstørrelsen af sacchariderne er over 50 kDa.
7. Immunogen sammensætning ifølge krav 6, som omfatter serotype 1 med en gennemsnitlig saccharidstørrelse på mellem 300 og 400 kDa.
8. Immunogen sammensætning ifølge krav 6 og 7, som omfatter serotype 5 med en gennemsnitlig saccharidstørrelse på mellem 350 og 450 kDa.
9. Immunogen sammensætning ifølge et hvilket som helst af kravene 6 til 8, som omfatter serotype 7F med en gennemsnitlig saccharidstørrelse på mellem 200 og 300 kDa.
10. Vaccine omfattende den immunogene sammensætning ifølge et hvilket som helst af kravene 1 til 9 og et farmaceutisk acceptabelt excipiens.
11. Fremgangsmåde til fremstilling af vaccinen ifølge krav 10, omfattende trinnet at blande den immunogene sammensætning ifølge et hvilket som helst af kravene 1 til 9 med en farmaceutisk acceptabel excipiens.
12. Immunogen sammensætning ifølge krav 1-9 eller vaccinen ifølge krav 10 til anvendelse i behandling eller forebyggelse af sygdom forårsaget af Streptococcus pneumo-n/'ae-infektion.
13. Immunogen sammensætning ifølge krav 1-9 eller vaccinen ifølge krav 10 til anvendelse i behandling eller forebyggelse af sygdom forårsaget af Streptococcus pneumo-n/'ae-infektion ifølge krav 12, hvor sygdommen er enten eller både lungebetændelse og invasiv pneumokok-sygdom (IPS) hos ældre mennesker, eksacerbationer af kronisk ob-struktiv lungesygdom (KOL) hos ældre mennesker, otitis media hos spædbørn, meningitis og/eller bakteriæmi hos spædbørn, eller lungebetændelse og/eller konjunktivitis hos spædbørn.
DK15195398.1T 2005-12-22 2006-12-20 Pneumokok-polysaccharidkonjugat-vaccine DK3017827T3 (da)

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
GB0526232A GB0526232D0 (en) 2005-12-22 2005-12-22 Vaccine
GBGB0607088.2A GB0607088D0 (en) 2006-04-07 2006-04-07 Vaccine
GB0607087A GB0607087D0 (en) 2006-04-07 2006-04-07 Vaccine
GB0609902A GB0609902D0 (en) 2006-05-18 2006-05-18 Novel composition
GB0620337A GB0620337D0 (en) 2006-10-12 2006-10-12 Vaccine
GBGB0620336.8A GB0620336D0 (en) 2006-10-12 2006-10-12 Vaccine
GB0620815A GB0620815D0 (en) 2006-10-19 2006-10-19 Vaccine
GB0620816A GB0620816D0 (en) 2006-10-19 2006-10-19 vaccine
PCT/GB2006/004634 WO2007068907A2 (en) 2005-12-13 2006-12-12 Vaccine compositions comprising a saponin adjuvant
EP06830744.6A EP1973564B1 (en) 2005-12-22 2006-12-20 Vaccine comprising streptococcus pneumoniae capsular polysaccharide conjugates

Publications (1)

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DK3017827T3 true DK3017827T3 (da) 2019-02-18

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Family Applications (5)

Application Number Title Priority Date Filing Date
DK10192663.2T DK2384765T3 (da) 2005-12-22 2006-12-20 Vaccine mod Streptococcus pneumoniae.
DK06830744.6T DK1973564T3 (da) 2005-12-22 2006-12-20 Vaccine omfattende streptococcus pneumoniae-kapselpolysaccharidkonjugat
DK15195398.1T DK3017827T3 (da) 2005-12-22 2006-12-20 Pneumokok-polysaccharidkonjugat-vaccine
DK06830743.8T DK1962899T3 (da) 2005-12-22 2006-12-20 Pneumococcus-polysaccharid-konjugat-vaccine
DK06841492.9T DK1968631T3 (da) 2005-12-22 2006-12-20 Vaccine

Family Applications Before (2)

Application Number Title Priority Date Filing Date
DK10192663.2T DK2384765T3 (da) 2005-12-22 2006-12-20 Vaccine mod Streptococcus pneumoniae.
DK06830744.6T DK1973564T3 (da) 2005-12-22 2006-12-20 Vaccine omfattende streptococcus pneumoniae-kapselpolysaccharidkonjugat

Family Applications After (2)

Application Number Title Priority Date Filing Date
DK06830743.8T DK1962899T3 (da) 2005-12-22 2006-12-20 Pneumococcus-polysaccharid-konjugat-vaccine
DK06841492.9T DK1968631T3 (da) 2005-12-22 2006-12-20 Vaccine

Country Status (37)

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US (10) US20090010959A1 (da)
EP (10) EP3130348A1 (da)
JP (7) JP5461838B2 (da)
KR (5) KR101418240B1 (da)
CN (6) CN110179974B (da)
AR (3) AR058592A1 (da)
AT (1) ATE520415T1 (da)
AU (4) AU2006327036B2 (da)
BR (3) BRPI0620460B8 (da)
CA (5) CA2634885C (da)
CL (1) CL2013002106A1 (da)
CR (2) CR10119A (da)
CY (5) CY1112677T1 (da)
DK (5) DK2384765T3 (da)
EA (3) EA014649B1 (da)
ES (4) ES2707499T3 (da)
HK (1) HK1120230A1 (da)
HR (4) HRP20110685T1 (da)
HU (3) HUE041979T2 (da)
IL (5) IL191913A (da)
JO (1) JO2813B1 (da)
LT (3) LT1973564T (da)
MA (3) MA30066B1 (da)
MX (2) MX2008008140A (da)
MY (4) MY148141A (da)
NO (4) NO346529B1 (da)
NZ (4) NZ569076A (da)
PE (2) PE20071305A1 (da)
PH (1) PH12014502544A1 (da)
PL (5) PL1968631T3 (da)
PT (5) PT1968631E (da)
SG (1) SG168517A1 (da)
SI (5) SI1962899T1 (da)
TR (1) TR201900418T4 (da)
TW (4) TW201350129A (da)
UA (2) UA96583C2 (da)
WO (3) WO2007071707A2 (da)

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EA011480B1 (ru) * 2000-06-29 2009-04-28 Глаксосмитклайн Байолоджикалс С.А. Поливалентная вакцинная композиция
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