DK2255826T3 - Neisseria-vaccinesammensætninger omfattende en kombination af antigener. - Google Patents

Neisseria-vaccinesammensætninger omfattende en kombination af antigener. Download PDF

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Publication number
DK2255826T3
DK2255826T3 DK10177890.0T DK10177890T DK2255826T3 DK 2255826 T3 DK2255826 T3 DK 2255826T3 DK 10177890 T DK10177890 T DK 10177890T DK 2255826 T3 DK2255826 T3 DK 2255826T3
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protein
outer membrane
antigens
strain
hsf
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DK10177890.0T
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English (en)
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Francois-Xavier Jacques Berthet
Ralph Biemans
Philippe Denoel
Christiane Feron
Carine Goraj
Jan Poolman
Vincent Weynants
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Glaxosmithkline Biologicals Sa
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Priority claimed from GB0218035A external-priority patent/GB0218035D0/en
Priority claimed from GB0218036A external-priority patent/GB0218036D0/en
Priority claimed from GB0218037A external-priority patent/GB0218037D0/en
Priority claimed from GB0218051A external-priority patent/GB0218051D0/en
Priority claimed from GBGB0220197.8A external-priority patent/GB0220197D0/en
Priority claimed from GBGB0220199.4A external-priority patent/GB0220199D0/en
Priority claimed from GB0225531A external-priority patent/GB0225531D0/en
Priority claimed from GB0225524A external-priority patent/GB0225524D0/en
Priority claimed from GB0230170A external-priority patent/GB0230170D0/en
Priority claimed from GB0230164A external-priority patent/GB0230164D0/en
Priority claimed from GB0230168A external-priority patent/GB0230168D0/en
Priority claimed from GB0305028A external-priority patent/GB0305028D0/en
Application filed by Glaxosmithkline Biologicals Sa filed Critical Glaxosmithkline Biologicals Sa
Publication of DK2255826T3 publication Critical patent/DK2255826T3/da
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    • 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
    • A61K39/095—Neisseria
    • 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
    • A61K39/102—Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • 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
    • A61K39/104—Pseudomonadales, e.g. Pseudomonas
    • A61K39/1045—Moraxella
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/22—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Neisseriaceae (F)
    • C—CHEMISTRY; METALLURGY
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • 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
    • A61K2039/55516—Proteins; Peptides
    • 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
    • A61K2039/55572—Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
    • 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
    • A61K2039/55577—Saponins; Quil A; QS21; ISCOMS
    • 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
    • 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)
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  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • General Chemical & Material Sciences (AREA)
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  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Communicable Diseases (AREA)
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  • Zoology (AREA)
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  • General Engineering & Computer Science (AREA)
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  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (17)

1. Immunogen sammensætning omfattende GNA1870, NadA og Lipo28, hvor antigenerne, når de er til stede i en ydre membranvesikel, er blevet opreguleret i den ydre membranvesikel, med det forbehold, at den immunogene sammensætning ikke er en af følgende sammensætninger beskrevet i WO 2004/032958: - en blanding af (1) et 'NadA'-protein; (2) et ’741’-protein; (3) et ’936’-protein; (4) et ’953'-protein; og (5) et '287'-protein; - en blanding af AG287-953-hybridprotein, 936-AG741-hybridprotein, NadA(NL)(c)-protein og et aluminiumhydroxidhjælpestof; - en blanding af AG287-953-hybridprotein, 936-AG741-hybridprotein, NadA(NL)(c)-protein og et aluminiumhydroxidhjælpestof, i kombination med OMV'er frembragt ud fra stamme H44/76; eller en blanding af AG287-953-hybridprotein, 936-AG741-hybridprotein, NadA(NL)(c)-protein og et aluminiumhydroxidhjælpestof, i kombination med OMV'er frembragt ud fra stamme 394/98.
2. Immunogen sammensætning ifølge krav 1, hvor sammensætningen: a) er en underenhedssammensætning; b) omfatter et præparat af en ydre membranvesikel, hvor antigenerne er blevet opreguleret i den ydre membranvesikel; eller c) omfatter en underenhedssammensætning med et eller flere af antigenerne, og et præparat af en ydre membranvesikel med mindst et antigen, som er blevet opreguleret i den ydre membranvesikel.
3. Immunogen sammensætning ifølge krav 2(b) eller(c), hvor en værtscelle, fra hvilken præparatet af den ydre membranvesikel er afledt: a) er blevet manipuleret til at nedregulere udtrykkeisen fra et eller flere af IgtB eller IgtE; b) er ude af stand til at danne kapselpolysaccharid og er blevet manipuleret til at nedregulere udtrykkelse fra et eller flere blandt siaD, ctrA, ctrB, ctrC, ctrD, synA (ækvivalent med synX og siaA) eller synB (ækvivalent med siaB) og synC (ækvivalent med siaC); c) er blevet manipuleret til at nedregulere udtrykkeisen af et eller flere af OpC, OpA eller PorA; d) er blevet manipuleret til at nedregulere udtrykkeisen af FrpB; og/eller e) er blevet manipuleret til at nedregulere udtrykkeisen fra msbB og/eller htrB.
4. Immunogen sammensætning ifølge kravene 2(b) eller (c) eller 3, hvor præparatet af den ydre membranvesikel indeholder LPS, der er konjugeret til et ydre membranprotein.
5. Immunogen sammensætning ifølge kravene 1-4 omfattende et antigen afledt fra Neisseria meningitidis eller Neisseria gonorrhoeae.
6. Immunogen sammensætning ifølge krav 5, hvor alle Neisseria-antigener er afledt fra N. meningitidis serogruppe B. 2
7. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, yderligere omfattende et eller flere bakteriekapselpolysaccharider eller -oligosaccharider.
8. Immunogen sammensætning ifølge krav 7, hvor kapselpolysacchariderne eller -oligosacchariderne er afledt fra bakterier udvalgt fra gruppen bestående af: Neisseria meningitidis serogruppe A, C, Y og W-135.
9. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, yderligere omfattende et hjælpestof.
10. Immunogen sammensætning ifølge krav 9, hvor hjælpestoffet omfatter aluminiumhydroxidgel.
11. Vaccine omfattende den immunogene sammensætning ifølge krav 1-10 og et farmaceutisk acceptabelt bærestof.
12. Vaccine omfattende et eller flere polynukleotider, hvis udtrykkelse styres af en eukaryot promotor kodende for GNA1870, NadA og Lipo28.
13. Anvendelse af vaccine ifølge krav 11 eller krav 12 til fremstilling af et lægemiddel til behandling eller forebyggelse af infektion med Neisseria.
14. Vaccine ifølge krav 11 eller krav 12 til brug i behandling eller forebyggelse af infektion med Neisseria.
15. Fremgangsmåde fil fremstilling af den immunogene sammensætning ifølge krav 1-10, hvilken fremgangsmåde omfatter et trin, hvor der sker sammenblanding af i det mindste GNA1870-, NadA- og Lipo28-antigener fra Neisseria.
16. Fremgangsmåde til fremstilling af den immunogene sammensætning ifølge krav 2(b) eller (c) eller 3-9, hvilken fremgangsmåde omfatter et trin, hvor der sker isolation af ydre membranvesikler fra en Neisseria-kultur.
17. Fremgangsmåde til fremstilling af vaccine ifølge krav 11, hvilken fremgangsmåde omfatter et trin, hvor der sker kombination af den immunogene sammensætning ifølge krav 1-10 med et farmaceutisk acceptabelt bærestof.
DK10177890.0T 2002-08-02 2003-07-31 Neisseria-vaccinesammensætninger omfattende en kombination af antigener. DK2255826T3 (da)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
GB0218037A GB0218037D0 (en) 2002-08-02 2002-08-02 Vaccine composition
GB0218051A GB0218051D0 (en) 2002-08-02 2002-08-02 Vaccine composition
GB0218035A GB0218035D0 (en) 2002-08-02 2002-08-02 Vaccine composition
GB0218036A GB0218036D0 (en) 2002-08-02 2002-08-02 Vaccine
GBGB0220199.4A GB0220199D0 (en) 2002-08-30 2002-08-30 Mutant protein and refolding method
GBGB0220197.8A GB0220197D0 (en) 2002-08-30 2002-08-30 Refolding method
GB0225531A GB0225531D0 (en) 2002-11-01 2002-11-01 Vaccine
GB0225524A GB0225524D0 (en) 2002-11-01 2002-11-01 Vaccine composition
GB0230170A GB0230170D0 (en) 2002-12-24 2002-12-24 Vaccine
GB0230164A GB0230164D0 (en) 2002-12-24 2002-12-24 Vaccine composition
GB0230168A GB0230168D0 (en) 2002-12-24 2002-12-24 Vaccine composition
GB0305028A GB0305028D0 (en) 2003-03-05 2003-03-05 Vaccine
EP03784153A EP1524993B1 (en) 2002-08-02 2003-07-31 Neisserial vaccine compositions comprising a combination of antigens

Publications (1)

Publication Number Publication Date
DK2255826T3 true DK2255826T3 (da) 2016-06-20

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Application Number Title Priority Date Filing Date
DK03784153.3T DK1524993T3 (da) 2002-08-02 2003-07-31 Neisseria-vaccinesammensætning omfattende en kombination af antigener
DK10177890.0T DK2255826T3 (da) 2002-08-02 2003-07-31 Neisseria-vaccinesammensætninger omfattende en kombination af antigener.

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DK03784153.3T DK1524993T3 (da) 2002-08-02 2003-07-31 Neisseria-vaccinesammensætning omfattende en kombination af antigener

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US (9) US20060057160A1 (da)
EP (11) EP2258385A3 (da)
JP (7) JP4740738B2 (da)
KR (6) KR101140033B1 (da)
CN (2) CN1671413A (da)
AU (6) AU2003260357B2 (da)
CA (4) CA2493092A1 (da)
CO (3) CO5680456A2 (da)
CY (3) CY1114243T1 (da)
DE (2) DE20321889U1 (da)
DK (2) DK1524993T3 (da)
ES (3) ES2575014T3 (da)
HK (1) HK1077014A1 (da)
HU (1) HUE029200T2 (da)
IL (3) IL165660A0 (da)
IS (3) IS7593A (da)
LU (1) LU92262I2 (da)
MX (3) MXPA05001349A (da)
MY (1) MY149591A (da)
NO (3) NO20050008L (da)
NZ (4) NZ537181A (da)
PL (5) PL375408A1 (da)
PT (2) PT2255826E (da)
SI (2) SI2255826T1 (da)
TW (1) TWI360424B (da)
WO (4) WO2004015099A2 (da)

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