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DK2184071T3 - Kapselformige polysaccharidopløsnings- og kombinationsvacciner - Google Patents

Kapselformige polysaccharidopløsnings- og kombinationsvacciner Download PDF

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Publication number
DK2184071T3
DK2184071T3 DK09075005.0T DK09075005T DK2184071T3 DK 2184071 T3 DK2184071 T3 DK 2184071T3 DK 09075005 T DK09075005 T DK 09075005T DK 2184071 T3 DK2184071 T3 DK 2184071T3
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DK
Denmark
Prior art keywords
saccharide
polysaccharide
vol
serogroup
capsular
Prior art date
Application number
DK09075005.0T
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English (en)
Inventor
Paolo Costantino
Original Assignee
Glaxosmithkline Biologicals Sa
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Classifications

    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23J—PROTEIN COMPOSITIONS FOR FOODSTUFFS; WORKING-UP PROTEINS FOR FOODSTUFFS; PHOSPHATIDE COMPOSITIONS FOR FOODSTUFFS
    • A23J1/00—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites
    • A23J1/04—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites from fish or other sea animals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23J—PROTEIN COMPOSITIONS FOR FOODSTUFFS; WORKING-UP PROTEINS FOR FOODSTUFFS; PHOSPHATIDE COMPOSITIONS FOR FOODSTUFFS
    • A23J1/00—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites
    • A23J1/20—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites from milk, e.g. casein; from whey
    • A23J1/205—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites from milk, e.g. casein; from whey from whey, e.g. lactalbumine
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • 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
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092—Streptococcus
    • 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
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H15/00—Compounds containing hydrocarbon or substituted hydrocarbon radicals directly attached to hetero atoms of saccharide radicals
    • C07H15/02—Acyclic radicals, not substituted by cyclic structures
    • C07H15/04—Acyclic radicals, not substituted by cyclic structures attached to an oxygen atom of the saccharide radical
    • 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
    • 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
    • C07K14/285—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Pasteurellaceae (F), e.g. Haemophilus influenza
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09F—NATURAL RESINS; FRENCH POLISH; DRYING-OILS; OIL DRYING AGENTS, i.e. SICCATIVES; TURPENTINE
    • C09F1/00—Obtaining purification, or chemical modification of natural resins, e.g. oleo-resins
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09G—POLISHING COMPOSITIONS; SKI WAXES
    • C09G1/00—Polishing compositions
    • 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
    • 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S424/00—Drug, bio-affecting and body treating compositions
    • Y10S424/831—Drug, bio-affecting and body treating compositions involving capsular polysaccharide of bacterium, e.g. polyribosyl ribitol phosphate

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Formation And Processing Of Food Products (AREA)

Claims (13)

1. Fremgangsmåde til oprensning og konjugering af et bakterielt kapselformigt poly-saccharid til et bærerprotein og derefter at blande det konjugerede polysaccharid med yderligere kapselformigt saccharid for at tilvejebringe en blanding, omfattende: at oprense polysaccharidet, omfattende trinnene af (a) bundfældning af polysaccha-ridet ved anvendelse af én eller flere kationiske detergenter, efterfulgt af (b) opløsning af det bundfældede polysaccharid ved anvendelse afen alkohol, konjugering af polysaccharidet til et bærerprotein, hvor bærerproteinet er et bakterielt toksin eller toxoid, og at blande kapselformigt saccharid fra Neisseria nieningitidis for at tilvejebringe en blanding omfattende kapselformige saccharider fra serogruppe Y og én eller begge af se-rogrupperne C og W135, hvor: forholdet (vægt/vægt) af MenY-saccharid:MenW135-saccharid er større end 1 og/eller forholdet (vægt/vægt) af MenY-saccharid:MenC-saccharid mindre end 1; og de kapselformige saccharider er konjugeret til bærerprotein(er), hvor det bakterielle kapselformige polysaccharid er fra Neisseria meningitidis, eller fra Haemophilus influenza, eller fra Streptococcus pneumoniae.
2. Fremgangsmåde ifølge krav 1, hvor det/de kationisk(e) detergent(er) omfatter et cetyltrimethylammoniumsalt, et tetrabutylammoniumsalt, et myristyltrimethylammonium-salt og/eller hexadimethrinbromid.
3. Fremgangsmåde ifølge krav 1 eller krav 2, hvor alkoholen der anvendes i trin (b) omfatter ethanol, og hvor ethanolen har en endelig koncentration på mellem 50% og 95%.
4. Fremgangsmåde ifølge et hvilket som helst foregående krav, hvor polysaccharidet tilvejebragt i trin (b) derefter bundfældes.
5. Fremgangsmåde ifølge krav 4, hvor bundfældning er ved tilsætning af calcium- eller natriumsalte.
6. Fremgangsmåde ifølge et hvilket som helst foregående krav, hvor saccharidet aktiveres forud for konjugering
7. Fremgangsmåde ifølge krav 6, hvor aktivering involverer en cyanylerende reagens.
8. Fremgangsmåde ifølge et hvilket som helst foregående krav, hvor konjugering er med en linker.
9. Fremgangsmåde ifølge et hvilket som helst foregående krav, hvor det konjugerede saccharid har et saccharid:protein forhold (vægt/vægt) mellem 0,5:1 og 5:1.
10. Fremgangsmåde ifølge et hvilket som helst foregående krav, hvor bærerproteinet er difteritoxoid eller tetanustoksoid.
11. Fremgangsmåde ifølge et hvilket som helst foregående krav, hvor, efter konjugering, frie og konjugerede saccharider er adskilte.
12. Fremgangsmåde ifølge krav 11, hvor adskillelsen anvender hydrofobisk kromato grafi, tangentiel ultrafiltrering, eller diafiltrering.
13. Fremgangsmåde ifølge et hvilket som helst foregående krav, yderligere omfattende trin af vaccineformulering omfattende at blande saccharidantigen(et/erne) med et adjuvans, som er en aluminiumphosphat og/eller en aluminiumhydroxid.
DK09075005.0T 2001-06-20 2002-06-20 Kapselformige polysaccharidopløsnings- og kombinationsvacciner DK2184071T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0115176.0A GB0115176D0 (en) 2001-06-20 2001-06-20 Capular polysaccharide solubilisation and combination vaccines
EP06075175A EP1741442B1 (en) 2001-06-20 2002-06-20 Neisseria meningitidis combination vaccines

Publications (1)

Publication Number Publication Date
DK2184071T3 true DK2184071T3 (da) 2016-11-07

Family

ID=9917070

Family Applications (6)

Application Number Title Priority Date Filing Date
DK10179797.5T DK2277536T3 (da) 2001-06-20 2002-06-20 Oprensning af bakterielle kapselpolysaccharider
DK09075005.0T DK2184071T3 (da) 2001-06-20 2002-06-20 Kapselformige polysaccharidopløsnings- og kombinationsvacciner
DK02755452.6T DK1401489T4 (da) 2001-06-20 2002-06-20 Solubilisering af kapselpolysaccharid
DK06075175.7T DK1741442T3 (da) 2001-06-20 2002-06-20 Neisseria meningitidis-kombinationavacciner
DK09075006.8T DK2189165T3 (da) 2001-06-20 2002-06-20 Kapselpolysaccharidsolubilisering og kombinationsvacciner
DK10007477.2T DK2263688T4 (da) 2001-06-20 2002-06-20 Kombinationsvacciner mod neisseria meningitidis

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK10179797.5T DK2277536T3 (da) 2001-06-20 2002-06-20 Oprensning af bakterielle kapselpolysaccharider

Family Applications After (4)

Application Number Title Priority Date Filing Date
DK02755452.6T DK1401489T4 (da) 2001-06-20 2002-06-20 Solubilisering af kapselpolysaccharid
DK06075175.7T DK1741442T3 (da) 2001-06-20 2002-06-20 Neisseria meningitidis-kombinationavacciner
DK09075006.8T DK2189165T3 (da) 2001-06-20 2002-06-20 Kapselpolysaccharidsolubilisering og kombinationsvacciner
DK10007477.2T DK2263688T4 (da) 2001-06-20 2002-06-20 Kombinationsvacciner mod neisseria meningitidis

Country Status (23)

Country Link
US (9) US8753651B2 (da)
EP (10) EP2189165B1 (da)
JP (4) JP5075317B2 (da)
CN (4) CN100482273C (da)
AT (3) ATE322287T1 (da)
AU (3) AU2002321716B2 (da)
BE (4) BE2010C031I2 (da)
BR (2) BR122019009186B8 (da)
CA (3) CA2450203C (da)
CY (6) CY1110820T1 (da)
DE (6) DE122010000040I1 (da)
DK (6) DK2277536T3 (da)
ES (9) ES2603275T3 (da)
FR (4) FR10C0043I1 (da)
GB (1) GB0115176D0 (da)
LU (4) LU91732I2 (da)
MX (1) MXPA03011462A (da)
NL (3) NL300460I2 (da)
NZ (2) NZ529881A (da)
PT (6) PT2277537E (da)
RU (2) RU2381814C2 (da)
TR (2) TR201808055T4 (da)
WO (1) WO2003007985A2 (da)

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