RU2015100140A - Поливалентная композиция, содержащая конъюгаты пневмококковый полисахарид-белок - Google Patents
Поливалентная композиция, содержащая конъюгаты пневмококковый полисахарид-белок Download PDFInfo
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- RU2015100140A RU2015100140A RU2015100140A RU2015100140A RU2015100140A RU 2015100140 A RU2015100140 A RU 2015100140A RU 2015100140 A RU2015100140 A RU 2015100140A RU 2015100140 A RU2015100140 A RU 2015100140A RU 2015100140 A RU2015100140 A RU 2015100140A
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- 239000000203 mixture Substances 0.000 title claims abstract 17
- 150000004676 glycans Chemical class 0.000 title claims abstract 5
- 229920001282 polysaccharide Polymers 0.000 title claims abstract 5
- 239000005017 polysaccharide Substances 0.000 title claims abstract 5
- 102000004169 proteins and genes Human genes 0.000 title 1
- 108090000623 proteins and genes Proteins 0.000 title 1
- 230000002163 immunogen Effects 0.000 claims abstract 16
- 239000002671 adjuvant Substances 0.000 claims abstract 12
- 102000014914 Carrier Proteins Human genes 0.000 claims abstract 6
- 108010078791 Carrier Proteins Proteins 0.000 claims abstract 6
- ILRRQNADMUWWFW-UHFFFAOYSA-K aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 claims abstract 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract 4
- 241000193998 Streptococcus pneumoniae Species 0.000 claims abstract 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims abstract 4
- 229910052782 aluminium Inorganic materials 0.000 claims abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 4
- 229940031000 streptococcus pneumoniae Drugs 0.000 claims abstract 4
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims abstract 2
- DIZPMCHEQGEION-UHFFFAOYSA-H aluminium sulfate (anhydrous) Chemical compound [Al+3].[Al+3].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O DIZPMCHEQGEION-UHFFFAOYSA-H 0.000 claims abstract 2
- DUMIASQJCCZABP-UHFFFAOYSA-N butanedioic acid;sodium Chemical compound [Na].OC(=O)CCC(O)=O DUMIASQJCCZABP-UHFFFAOYSA-N 0.000 claims abstract 2
- 150000001720 carbohydrates Chemical class 0.000 claims abstract 2
- 239000000945 filler Substances 0.000 claims abstract 2
- 230000028993 immune response Effects 0.000 claims abstract 2
- 230000001939 inductive effect Effects 0.000 claims abstract 2
- 239000011780 sodium chloride Substances 0.000 claims abstract 2
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- A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
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- 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
-
- A—HUMAN NECESSITIES
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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
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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
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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
- 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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- 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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- 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
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- 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
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- 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
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- 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
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- 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
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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
- 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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- 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
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Abstract
1. Мультивалентная иммуногенная композиция, содержащая 15 различных конъюгатов полисахарид-белок, а также физиологически приемлемую основу, отличающаяся тем, что каждый из конъюгатов полисахарид-белок содержит капсульный полисахарид, полученный из разных серотипов Streptococcus pneumoniae, конъюгированный с белком-носителем, причем капсульные полисахариды получены из серотипов 1, 2, 3, 4, 5, 6А, 6В, 7F, 9N, 9V, 14, 18С, 19А, 19F и 23F.2. Мультивалентная иммуногенная композиция по п. 1, отличающаяся тем, что белком-носителем является CRM.3. Мультивалентная иммуногенная композиция по п. 1, дополнительно содержащая адъювант.4. Мультивалентная иммуногенная композиция по п. 3, отличающаяся тем, что адъювантом является 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 индуцирования иммунного ответа на конъюгат капсульного полисахарида Streptococcus pneumoniae, содержащая иммунологически эффективное количество мультивалентной иммуногенной композиции по любому из пп. 1-6.8. Фармацевтическая композиция по п. 7, отличающаяся тем, что мультивалентная иммуногенная композиция составлена в виде однократной 0,5 мл дозы, содержащей:по 2 мкг каждого сахарида, кроме 6В в количестве 4 мкг;приблизительно 34 мкг белка-носителя CRM;адъювант на основе 0,125 мг элементарного алюминия (0,5 мг фосфата алюминия): ибуфер на основе хлорида натрия и янтарнокислого натрия в качестве наполнителей.
Claims (8)
1. Мультивалентная иммуногенная композиция, содержащая 15 различных конъюгатов полисахарид-белок, а также физиологически приемлемую основу, отличающаяся тем, что каждый из конъюгатов полисахарид-белок содержит капсульный полисахарид, полученный из разных серотипов Streptococcus pneumoniae, конъюгированный с белком-носителем, причем капсульные полисахариды получены из серотипов 1, 2, 3, 4, 5, 6А, 6В, 7F, 9N, 9V, 14, 18С, 19А, 19F и 23F.
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 адъювантом является 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 индуцирования иммунного ответа на конъюгат капсульного полисахарида Streptococcus pneumoniae, содержащая иммунологически эффективное количество мультивалентной иммуногенной композиции по любому из пп. 1-6.
8. Фармацевтическая композиция по п. 7, отличающаяся тем, что мультивалентная иммуногенная композиция составлена в виде однократной 0,5 мл дозы, содержащей:
по 2 мкг каждого сахарида, кроме 6В в количестве 4 мкг;
приблизительно 34 мкг белка-носителя CRM197;
адъювант на основе 0,125 мг элементарного алюминия (0,5 мг фосфата алюминия): и
буфер на основе хлорида натрия и янтарнокислого натрия в качестве наполнителей.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2012-0065893 | 2012-06-20 | ||
| KR1020120065893A KR102057217B1 (ko) | 2012-06-20 | 2012-06-20 | 다가 폐렴구균 다당류-단백질 접합체 조성물 |
| PCT/KR2013/005392 WO2013191459A1 (ko) | 2012-06-20 | 2013-06-19 | 다가 폐렴구균 다당류-단백질 접합체 조성물 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2015100140A true RU2015100140A (ru) | 2016-08-10 |
| RU2605834C2 RU2605834C2 (ru) | 2016-12-27 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015100140/15A RU2605834C2 (ru) | 2012-06-20 | 2013-06-19 | Поливалентная композиция, содержащая конъюгаты пневмококковый полисахарид-белок |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US10034949B2 (ru) |
| EP (1) | EP2865392B2 (ru) |
| JP (1) | JP2015520227A (ru) |
| KR (1) | KR102057217B1 (ru) |
| CN (1) | CN104755102B (ru) |
| AU (1) | AU2013278145B2 (ru) |
| BR (1) | BR112014032091B1 (ru) |
| CA (1) | CA2877648C (ru) |
| CO (1) | CO7240387A2 (ru) |
| ES (1) | ES2613720T5 (ru) |
| MX (1) | MX358977B (ru) |
| PH (1) | PH12014502843A1 (ru) |
| RU (1) | RU2605834C2 (ru) |
| WO (1) | WO2013191459A1 (ru) |
Families Citing this family (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104815327A (zh) | 2005-04-08 | 2015-08-05 | 惠氏有限责任公司 | 多价肺炎球菌多糖-蛋白质缀合物组合物 |
| KR102057217B1 (ko) * | 2012-06-20 | 2020-01-22 | 에스케이바이오사이언스 주식회사 | 다가 폐렴구균 다당류-단백질 접합체 조성물 |
| HRP20211288T1 (hr) * | 2014-01-21 | 2021-11-26 | Pfizer Inc. | Kapsularni polisaharidi bakterije streptococcus pneumoniae i njihovi konjugati |
| BR112016015835B1 (pt) * | 2014-01-21 | 2023-12-26 | Pfizer Inc | Processo de preparação de conjugados compreendendo polissacarídeos capsulares de streptococcus pneumoniae |
| US11160855B2 (en) * | 2014-01-21 | 2021-11-02 | Pfizer Inc. | Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof |
| FI3244917T3 (fi) * | 2015-01-15 | 2023-05-25 | Pfizer | Immunogeenisiä koostumuksia pneumokokkirokotteissa käytettäväksi |
| KR102045663B1 (ko) | 2015-05-04 | 2019-11-15 | 화이자 인코포레이티드 | B군 스트렙토코쿠스 폴리사카라이드-단백질 접합체, 접합체를 생산하는 방법, 접합체를 포함하는 면역원성 조성물, 및 그의 용도 |
| KR102876828B1 (ko) * | 2015-06-08 | 2025-10-27 | 세럼 인스티튜트 오브 인디아 프라이비트 리미티드 | 다당류-단백질 접합체의 흡착을 개선시키는 방법 및 그로부터 수득된 다가 백신 제제 |
| ES2857474T3 (es) | 2015-06-23 | 2021-09-29 | Biological E Ltd | Vacuna conjugada neumocócica multivalente |
| KR102225282B1 (ko) * | 2015-07-21 | 2021-03-10 | 화이자 인코포레이티드 | 접합된 캡슐형 사카라이드 항원을 포함하는 면역원성 조성물, 그를 포함하는 키트 및 그의 용도 |
| US11058757B2 (en) | 2016-03-31 | 2021-07-13 | Pogona, LLC | Saccharide-polypeptide conjugate compositions and methods of use thereof |
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| EP3493837B1 (en) | 2016-08-05 | 2022-08-31 | Sanofi Pasteur, Inc. | Multivalent pneumococcal polysaccharide-protein conjugate composition |
| MY192792A (en) * | 2016-09-06 | 2022-09-09 | Lg Chemical Ltd | A composition of multivalent pneumococcal capsular polysaccharide-carrier protein conjugates and use thereof |
| AU2017336806B2 (en) * | 2016-09-30 | 2024-06-27 | Biological E Limited | Multivalent pneumococcal vaccine compositions comprising polysaccharide-protein conjugates |
| WO2018080213A1 (ko) * | 2016-10-28 | 2018-05-03 | 주식회사 엘지화학 | 향상된 IgG 역가를 갖는 다가면역원성 조성물 및 이의 용도 |
| ES3024474T3 (en) | 2016-12-30 | 2025-06-04 | Vaxcyte Inc | Polypeptide-antigen conjugates with non-natural amino acids |
| US11951165B2 (en) | 2016-12-30 | 2024-04-09 | Vaxcyte, Inc. | Conjugated vaccine carrier proteins |
| EP3589314A4 (en) | 2017-02-24 | 2021-04-21 | Merck Sharp & Dohme Corp. | INCREASED IMMUNOGENICITY OF STREPTOCOCCUS PNEUMONIAE POLYSACCHARIDE PROTEIN CONJUGATES |
| PT3585803T (pt) | 2017-02-24 | 2025-12-22 | Merck Sharp & Dohme | Formulações de vacina pneumocócica conjugada |
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| WO2013191459A1 (ko) | 2013-12-27 |
| BR112014032091A2 (pt) | 2017-10-10 |
| MX358977B (es) | 2018-09-11 |
| CO7240387A2 (es) | 2015-04-17 |
| CN104755102A (zh) | 2015-07-01 |
| CA2877648A1 (en) | 2013-12-27 |
| PH12014502843B1 (en) | 2015-02-09 |
| MX2014016065A (es) | 2015-10-09 |
| JP2015520227A (ja) | 2015-07-16 |
| RU2605834C2 (ru) | 2016-12-27 |
| ES2613720T5 (es) | 2020-07-09 |
| CN104755102B (zh) | 2018-01-23 |
| US10058607B2 (en) | 2018-08-28 |
| EP2865392A4 (en) | 2016-01-20 |
| AU2013278145B2 (en) | 2016-04-21 |
| KR102057217B1 (ko) | 2020-01-22 |
| KR20130142574A (ko) | 2013-12-30 |
| US20150190520A1 (en) | 2015-07-09 |
| CA2877648C (en) | 2016-08-23 |
| US10034949B2 (en) | 2018-07-31 |
| EP2865392A1 (en) | 2015-04-29 |
| US20170232101A1 (en) | 2017-08-17 |
| PH12014502843A1 (en) | 2015-02-09 |
| ES2613720T3 (es) | 2017-05-25 |
| EP2865392B1 (en) | 2016-11-16 |
| EP2865392B2 (en) | 2020-02-12 |
| BR112014032091A8 (pt) | 2018-07-31 |
| AU2013278145A1 (en) | 2015-02-05 |
| BR112014032091B1 (pt) | 2022-07-26 |
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