RU2015121771A - Мультивалентная композиция на основе конъюгатов пневмококковый полисахарид-белок - Google Patents

Мультивалентная композиция на основе конъюгатов пневмококковый полисахарид-белок Download PDF

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RU2015121771A
RU2015121771A RU2015121771A RU2015121771A RU2015121771A RU 2015121771 A RU2015121771 A RU 2015121771A RU 2015121771 A RU2015121771 A RU 2015121771A RU 2015121771 A RU2015121771 A RU 2015121771A RU 2015121771 A RU2015121771 A RU 2015121771A
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immunogenic composition
multivalent immunogenic
adjuvant
composition according
aluminum
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RU2015121771A
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Ман-Хоон ПАРК
Хун Ким
Жи-Хай ЯНГ
Сеон-Ян ЯНГ
Мьон-Жи НО
Су-Жин ПАРК
Жин-Хван ШИН
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Ск Кемикалс Ко., Лтд.
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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
    • 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
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    • A—HUMAN NECESSITIES
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    • 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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    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/50—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
    • A61K47/62—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 a protein, peptide or polyamino acid
    • 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
    • A61K47/6415—Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
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    • 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
    • A61K47/50—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
    • A61K47/62—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 a protein, peptide or polyamino acid
    • 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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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • 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
    • 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]

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Claims (14)

1. Мультивалентная иммуногенная композиция, содержащая
13 различных конъюгатов полисахарид-белок вместе с физиологически приемлемой средой,
отличающаяся тем, что каждый из конъюгатов полисахарид-белок содержит капсульный полисахарид от отдельного серотипа Streptococcus pneumoniae, конъюгированный с белком-носителем, и капсульные полисахариды получены от 12 серотипов, выбранных из группы, состоящей из 1, 3, 4, 5, 6А, 6В, 7F, 9V, 14, 18С, 19А, 19F и 23F, и серотипа 22F или 33F.
2. Мультивалентная иммуногенная композиция по п. 1, отличающаяся тем, что белком-носителем является CRM197.
3. Мультивалентная иммуногенная композиция по п. 1, дополнительно содержащая адъювант.
4. Мультивалентная иммуногенная композиция по п. 3, отличающаяся тем, что адъювант представляет собой адъювант на основе алюминия.
5. Мультивалентная иммуногенная композиция по п. 4, отличающаяся тем, что адъювант выбран из группы, состоящей из фосфата алюминия, сульфата алюминия и гидроксида алюминия.
6. Мультивалентная иммуногенная композиция по п. 5, отличающаяся тем, что адъювантом является фосфат алюминия.
7. Фармацевтическая композиция для индукции иммунного ответа на конъюгаты капсульного полисахарида Streptococcus pneumoniae, при этом фармацевтическая композиция содержит иммунологически эффективное количество мультивалентной иммуногенной композиции по любому из пп. 1-6.
8. Фармацевтическая композиция по п. 7, отличающаяся тем, что мультивалентная иммуногенная композиция представляет собой однократную дозу 0,5 мл, составленную с содержанием:
2 мкг полисахарида каждого серотипа, за исключением 6В из расчета 4 мкг;
приблизительно 34 мкг белка-носителя CRM197;
адъюванта, содержащего 0,125 мг элементарного алюминия (0,5 мг фосфата алюминия); и
хлорида натрия, и буфера на основе сукцината натрия в качестве наполнителей.
RU2015121771A 2012-12-11 2013-12-05 Мультивалентная композиция на основе конъюгатов пневмококковый полисахарид-белок RU2613148C2 (ru)

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KR1020120143318A KR20140075201A (ko) 2012-12-11 2012-12-11 다가 폐렴구균 다당류-단백질 접합체 조성물
KR10-2012-0143318 2012-12-11
PCT/KR2013/011195 WO2014092378A1 (ko) 2012-12-11 2013-12-05 다가 폐렴구균 다당류-단백질 접합체 조성물

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EP (1) EP2932980B1 (ru)
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CA2894532A1 (en) 2014-06-19
DK2932980T3 (da) 2021-07-19
PH12015501270A1 (en) 2015-08-24
BR112015013513B1 (pt) 2023-02-07
PT2932980T (pt) 2021-07-29
BR112015013513A2 (pt) 2017-07-11
CO7461130A2 (es) 2015-11-30
CA2894532C (en) 2020-07-07
JP2016503016A (ja) 2016-02-01
EP2932980A1 (en) 2015-10-21
AU2013360597A1 (en) 2015-07-02
EP2932980B1 (en) 2021-06-30
RU2613148C2 (ru) 2017-03-15
PL2932980T3 (pl) 2021-11-08
WO2014092378A1 (ko) 2014-06-19
EP2932980A4 (en) 2016-07-06
CN104837504A (zh) 2015-08-12
MX2015007301A (es) 2016-01-20
BR112015013513A8 (pt) 2018-07-31

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