JP2020533439A5 - - Google Patents
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- JP2020533439A5 JP2020533439A5 JP2020513549A JP2020513549A JP2020533439A5 JP 2020533439 A5 JP2020533439 A5 JP 2020533439A5 JP 2020513549 A JP2020513549 A JP 2020513549A JP 2020513549 A JP2020513549 A JP 2020513549A JP 2020533439 A5 JP2020533439 A5 JP 2020533439A5
- Authority
- JP
- Japan
- Prior art keywords
- polysaccharide
- immunogenic composition
- protein
- composition according
- protein conjugate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 150000004676 glycans Chemical class 0.000 claims 26
- 229920001282 polysaccharide Polymers 0.000 claims 26
- 239000005017 polysaccharide Substances 0.000 claims 26
- 230000002163 immunogen Effects 0.000 claims 13
- 239000002671 adjuvant Substances 0.000 claims 7
- 102000014914 Carrier Proteins Human genes 0.000 claims 6
- 108010078791 Carrier Proteins Proteins 0.000 claims 6
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 6
- 108010071134 CRM197 (non-toxic variant of diphtheria toxin) Proteins 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- ILRRQNADMUWWFW-UHFFFAOYSA-K aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 claims 4
- 101800002949 Diphtheria toxin fragment B Proteins 0.000 claims 3
- 229960002885 histidine Drugs 0.000 claims 3
- 229960000814 tetanus toxoid Drugs 0.000 claims 3
- 208000034628 Celiac artery compression syndrome Diseases 0.000 claims 2
- 241000589517 Pseudomonas aeruginosa Species 0.000 claims 2
- 241000193998 Streptococcus pneumoniae Species 0.000 claims 2
- BBWBEZAMXFGUGK-UHFFFAOYSA-N bis(dodecylsulfanyl)-methylarsane Chemical compound CCCCCCCCCCCCS[As](C)SCCCCCCCCCCCC BBWBEZAMXFGUGK-UHFFFAOYSA-N 0.000 claims 2
- 229960003983 diphtheria toxoid Drugs 0.000 claims 2
- 238000000569 multi-angle light scattering Methods 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 229940031000 streptococcus pneumoniae Drugs 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
- HEBKCHPVOIAQTA-QWWZWVQMSA-N D-arabinitol Chemical compound OC[C@@H](O)C(O)[C@H](O)CO HEBKCHPVOIAQTA-QWWZWVQMSA-N 0.000 claims 1
- 241000588724 Escherichia coli Species 0.000 claims 1
- 101710082714 Exotoxin A Proteins 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 201000005702 Pertussis Diseases 0.000 claims 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 1
- 229910052782 aluminium Inorganic materials 0.000 claims 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims 1
- 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 1
- 229910052799 carbon Inorganic materials 0.000 claims 1
- 239000003153 chemical reaction reagent Substances 0.000 claims 1
- 108010031071 cholera toxoid Proteins 0.000 claims 1
- 230000021615 conjugation Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 230000028993 immune response Effects 0.000 claims 1
- 230000001939 inductive effect Effects 0.000 claims 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 1
- KHIWWQKSHDUIBK-UHFFFAOYSA-N periodic acid Chemical compound OI(=O)(=O)=O KHIWWQKSHDUIBK-UHFFFAOYSA-N 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
Claims (26)
- 前記多糖体が5〜5000の繰り返し単位を有する、請求項1に記載の多糖体。
- 前記多糖体が50〜1500の繰り返し単位を有する、請求項1に記載の多糖体。
- 前記多糖体が、MALSにより決定される10kDa〜2000kDaの平均分子量を有する、請求項1に記載の多糖体。
- 前記多糖体が、MALSにより決定される50kDa〜1500kDaの平均分子量を有する、請求項1に記載の多糖体。
- 前記多糖体が過ヨウ素酸塩によって活性化される、請求項6に記載の活性化多糖体。
- 前記キャリアタンパク質が、CRM197、ジフテリア毒素フラグメントB(DTFB)、DTFB C8、ジフテリアトキソイド(DT)、破傷風トキソイド(TT)、TTのフラグメントC、百日咳トキソイド、コレラトキソイド、E.coli LT、E.coli ST、またはシュードモナス・エルギノーサ由来の外毒素Aである、請求項9に記載の多糖体−タンパク質コンジュゲート。
- 前記キャリアタンパク質がCRM197である、請求項10に記載の多糖体−タンパク質コンジュゲート。
- 前記多糖体−タンパク質コンジュゲートが1000kDa〜10,000kDaの分子量を有する、請求項11に記載の多糖体−タンパク質コンジュゲート。
- 前記多糖体−タンパク質コンジュゲートが、0.4〜2.0の多糖体対タンパク質比を有する、請求項11に記載の多糖体−タンパク質コンジュゲート。
- 前記タンパク質が、アラビニトール糖の第2の炭素を介して前記多糖体にコンジュゲートされている、請求項13に記載の多糖体−タンパク質コンジュゲート。
- 請求項9から14のいずれか一項に記載の多糖体−タンパク質コンジュゲートと、薬学的に許容される担体とを含む免疫原性組成物。
- CRM197にコンジュゲートされた、ストレプトコッカス・ニューモニエの血清型1、2、3、4、5、6A、6B、6C、6D、7B、7C、7F、8、9N、9V、10A、11A、12F、14、15A、15B、15C、16F、17F、18C、19A、19F、20、21、22A、22F、23A、23B、23F、27、28A、31、33F、34、35A、35B、35Fおよび38のうちの少なくとも1つに由来する莢膜多糖体を含む多糖体−タンパク質コンジュゲートをさらに含む、請求項15に記載の免疫原性組成物。
- 存在する場合0.8〜8μg/mLの多糖体を含有する血清型6B多糖体を除いて、0.4〜4μg/mLの各多糖体と、多糖体の総量の約0.5倍〜3倍の量のCRM197キャリアタンパク質とを含有するように製剤化される、請求項16に記載の免疫原性組成物。
- 150mM塩化ナトリウムと、20mM L−ヒスチジン緩衝液と、0.05〜2%w/vの界面活性剤とをさらに含む、請求項17に記載の免疫原性組成物。
- アジュバントをさらに含む、請求項18に記載の免疫原性組成物。
- 前記アジュバントがアルミニウムベースのアジュバントである、請求項19に記載の免疫原性組成物。
- 前記アジュバントが、リン酸アルミニウム、硫酸アルミニウムおよび水酸化アルミニウムからなる群から選択される、請求項20に記載の免疫原性組成物。
- 前記アジュバントがリン酸アルミニウムである、請求項21に記載の免疫原性組成物。
- 前記リン酸アルミニウムアジュバントが0.05〜0.5mg/mLの濃度で存在する、請求項22に記載の免疫原性組成物。
- 150mM塩化ナトリウムと、20mM L−ヒスチジン緩衝液と、0.05〜2%w/vの界面活性剤とをさらに含む、請求項23に記載の免疫原性組成物。
- ストレプトコッカス・ニューモニエ莢膜多糖体に対する免疫応答を誘発するための、請求項15から24のいずれか一項に記載の免疫原性組成物。
- 前記免疫原性組成物が、存在する場合4μgである血清型6B多糖体を除いて、2μgの各多糖体と、約32μgのCRM197キャリアタンパク質と、0.125mgのリン酸アルミニウムアジュバントと、150mM塩化ナトリウムと、20mM L−ヒスチジン緩衝液と、0.2%w/vのPS−20とを含有するように製剤化された単一の0.5mL用量である、請求項25に記載の免疫原性組成物。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2024019152A JP2024056835A (ja) | 2017-09-07 | 2024-02-13 | 肺炎球菌多糖体および免疫原性多糖体-キャリアタンパク質コンジュゲートでのその使用 |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762555461P | 2017-09-07 | 2017-09-07 | |
US62/555,461 | 2017-09-07 | ||
US201862645252P | 2018-03-20 | 2018-03-20 | |
US62/645,252 | 2018-03-20 | ||
PCT/US2018/049308 WO2019050815A1 (en) | 2017-09-07 | 2018-09-04 | ANTI-PNEUMOCOCCAL POLYSACCHARIDES AND THEIR USE IN IMMUNOGENIC CONJUGATES POLYSACCHARIDE-PROTEIN CARRIER |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2024019152A Division JP2024056835A (ja) | 2017-09-07 | 2024-02-13 | 肺炎球菌多糖体および免疫原性多糖体-キャリアタンパク質コンジュゲートでのその使用 |
Publications (4)
Publication Number | Publication Date |
---|---|
JP2020533439A JP2020533439A (ja) | 2020-11-19 |
JP2020533439A5 true JP2020533439A5 (ja) | 2021-08-19 |
JPWO2019050815A5 JPWO2019050815A5 (ja) | 2023-11-27 |
JP7438102B2 JP7438102B2 (ja) | 2024-02-26 |
Family
ID=65634964
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2020513549A Active JP7438102B2 (ja) | 2017-09-07 | 2018-09-04 | 肺炎球菌多糖体および免疫原性多糖体-キャリアタンパク質コンジュゲートでのその使用 |
JP2024019152A Pending JP2024056835A (ja) | 2017-09-07 | 2024-02-13 | 肺炎球菌多糖体および免疫原性多糖体-キャリアタンパク質コンジュゲートでのその使用 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2024019152A Pending JP2024056835A (ja) | 2017-09-07 | 2024-02-13 | 肺炎球菌多糖体および免疫原性多糖体-キャリアタンパク質コンジュゲートでのその使用 |
Country Status (9)
Country | Link |
---|---|
EP (1) | EP3678654A4 (ja) |
JP (2) | JP7438102B2 (ja) |
KR (1) | KR20200051004A (ja) |
CN (2) | CN111093650B (ja) |
AU (2) | AU2018328037B2 (ja) |
BR (1) | BR112020004509A8 (ja) |
CA (1) | CA3074708A1 (ja) |
MX (1) | MX2020002555A (ja) |
WO (1) | WO2019050815A1 (ja) |
Families Citing this family (15)
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US11951165B2 (en) | 2016-12-30 | 2024-04-09 | Vaxcyte, Inc. | Conjugated vaccine carrier proteins |
US11197921B2 (en) | 2017-01-31 | 2021-12-14 | Merck Sharp & Dohme Corp. | Methods for making polysaccharide-protein conjugates |
KR20240011879A (ko) | 2017-02-24 | 2024-01-26 | 머크 샤프 앤드 돔 엘엘씨 | 스트렙토코쿠스 뉴모니아에 폴리사카라이드-단백질 접합체의 면역원성의 증진 |
US11400162B2 (en) | 2017-02-24 | 2022-08-02 | Merck Sharp & Dohme Llc | Processes for the formulation of pneumococcal polysaccharides for conjugation to a carrier protein |
US11524076B2 (en) | 2017-09-07 | 2022-12-13 | Merck Sharp & Dohme Llc | Pneumococcal polysaccharides and their use in immunogenic polysaccharide-carrier protein conjugates |
AU2018328035B2 (en) | 2017-09-07 | 2024-03-07 | Chitrananda Abeygunawardana | Pneumococcal polysaccharides and their use in immunogenic polysaccharide-carrier protein conjugates |
EP3678655A4 (en) | 2017-09-07 | 2021-05-05 | Merck Sharp & Dohme Corp. | ANTIPNEUMOCOCCAL POLYSACCHARIDES AND THEIR USE IN POLYSACCHARIDE-CARRIER PROTEIN IMMUNOGENIC CONJUGATES |
KR20200051005A (ko) | 2017-09-07 | 2020-05-12 | 머크 샤프 앤드 돔 코포레이션 | 폐렴구균 폴리사카라이드 및 면역원성 폴리사카라이드-담체 단백질 접합체에서의 그의 용도 |
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WO2019203599A1 (ko) | 2018-04-18 | 2019-10-24 | 에스케이바이오사이언스 주식회사 | 스트렙토코커스 뉴모니애 협막 다당류 및 그의 면역원성 접합체 |
KR20210002641A (ko) | 2018-04-30 | 2021-01-08 | 머크 샤프 앤드 돔 코포레이션 | 디메틸술폭시드 중의 동결건조된 돌연변이체 디프테리아 독소의 균질 용액을 제공하는 방법 |
JP2021522288A (ja) | 2018-04-30 | 2021-08-30 | メルク・シャープ・アンド・ドーム・コーポレーションMerck Sharp & Dohme Corp. | 肺炎球菌莢膜多糖類担体タンパク質複合体の製造方法 |
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2018
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- 2018-09-04 CN CN201880058217.4A patent/CN111093650B/zh active Active
- 2018-09-04 CN CN202410181167.6A patent/CN118063638A/zh active Pending
- 2018-09-04 JP JP2020513549A patent/JP7438102B2/ja active Active
- 2018-09-04 AU AU2018328037A patent/AU2018328037B2/en active Active
- 2018-09-04 CA CA3074708A patent/CA3074708A1/en active Pending
- 2018-09-04 WO PCT/US2018/049308 patent/WO2019050815A1/en active Application Filing
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- 2018-09-04 EP EP18853342.6A patent/EP3678654A4/en active Pending
- 2018-09-04 KR KR1020207009614A patent/KR20200051004A/ko not_active Application Discontinuation
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2024
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