JP2020533442A5 - - Google Patents
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- JP2020533442A5 JP2020533442A5 JP2020513626A JP2020513626A JP2020533442A5 JP 2020533442 A5 JP2020533442 A5 JP 2020533442A5 JP 2020513626 A JP2020513626 A JP 2020513626A JP 2020513626 A JP2020513626 A JP 2020513626A JP 2020533442 A5 JP2020533442 A5 JP 2020533442A5
- Authority
- JP
- Japan
- Prior art keywords
- polysaccharide
- immunogenic composition
- composition according
- protein conjugate
- adjuvant
- 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 Polymers 0.000 claims 29
- 150000004804 polysaccharides Polymers 0.000 claims 29
- 229920001282 polysaccharide Polymers 0.000 claims 28
- 239000005017 polysaccharide Substances 0.000 claims 28
- 230000002163 immunogen Effects 0.000 claims 13
- 230000000240 adjuvant Effects 0.000 claims 7
- 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
- 108010053187 Diphtheria Toxin Proteins 0.000 claims 5
- 102000016607 Diphtheria Toxin Human genes 0.000 claims 5
- ILRRQNADMUWWFW-UHFFFAOYSA-K Aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 claims 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 108010008785 Diphtheria toxin fragment B Proteins 0.000 claims 3
- 229960002885 Histidine Drugs 0.000 claims 3
- 229960000814 tetanus toxoid Drugs 0.000 claims 3
- 229940055023 Pseudomonas aeruginosa Drugs 0.000 claims 2
- 241000589517 Pseudomonas aeruginosa Species 0.000 claims 2
- 241000193998 Streptococcus pneumoniae Species 0.000 claims 2
- 229940031000 Streptococcus pneumoniae Drugs 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
- 239000004094 surface-active agent Substances 0.000 claims 2
- KHIWWQKSHDUIBK-UHFFFAOYSA-M AC1L4ZKD Chemical compound [O-]I(=O)(=O)=O KHIWWQKSHDUIBK-UHFFFAOYSA-M 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 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
- 241000588724 Escherichia coli Species 0.000 claims 1
- 101700057439 TOXA Proteins 0.000 claims 1
- 208000001877 Whooping Cough Diseases 0.000 claims 1
- 229910052782 aluminium Inorganic materials 0.000 claims 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminum Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 1
- 239000003153 chemical reaction reagent Substances 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
- 108010031071 cholera toxoid Proteins 0.000 claims 1
- 101700067277 chxA Proteins 0.000 claims 1
- 230000021615 conjugation Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000028993 immune response Effects 0.000 claims 1
- 230000001939 inductive effect Effects 0.000 claims 1
- 201000005702 pertussis Diseases 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- KEAYESYHFKHZAL-UHFFFAOYSA-N sodium Chemical compound [Na] KEAYESYHFKHZAL-UHFFFAOYSA-N 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10〜5000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100〜2500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100kDa〜4000kDa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100kDa〜3000kDaの平均分子量を有する、請求項1に記載の多糖体。
- 各xが、独立して0.5〜1.0である、請求項1に記載の多糖体。
- 各xが、独立して0.8〜1.0である、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8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10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、1,000kDa〜10,000kDaの分子量を有する、請求項12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12に記載の多糖体−タンパク質コンジュゲート。
- 請求項10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。
- 更に、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、24F、27、28A、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、20mM L−ヒスチジン緩衝液及び0.05〜2%w/vの界面活性剤をさらに含む、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、20mM L−ヒスチジン緩衝液、及び0.05〜2%w/vの界面活性剤をさらに含む、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 |
---|---|---|---|
JP2023009333A JP2023052619A (ja) | 2017-09-07 | 2023-01-25 | 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 (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762555479P | 2017-09-07 | 2017-09-07 | |
US62/555,479 | 2017-09-07 | ||
PCT/US2018/049309 WO2019050816A1 (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 |
---|---|---|---|
JP2023009333A Division JP2023052619A (ja) | 2017-09-07 | 2023-01-25 | 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 (3)
Publication Number | Publication Date |
---|---|
JP2020533442A JP2020533442A (ja) | 2020-11-19 |
JP2020533442A5 true JP2020533442A5 (ja) | 2021-08-19 |
JP7218358B2 JP7218358B2 (ja) | 2023-02-06 |
Family
ID=65634538
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP2020513626A Active JP7218358B2 (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 |
JP2023009333A Pending JP2023052619A (ja) | 2017-09-07 | 2023-01-25 | 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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JP2023009333A Pending JP2023052619A (ja) | 2017-09-07 | 2023-01-25 | 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 (10)
Country | Link |
---|---|
US (3) | US11389540B2 (ja) |
EP (1) | EP3678652A4 (ja) |
JP (2) | JP7218358B2 (ja) |
KR (1) | KR20200051005A (ja) |
CN (2) | CN111065387B (ja) |
AU (2) | AU2018328038B2 (ja) |
BR (1) | BR112020004502A8 (ja) |
CA (1) | CA3074711A1 (ja) |
MX (2) | MX2020002556A (ja) |
WO (1) | WO2019050816A1 (ja) |
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2018
- 2018-09-04 KR KR1020207009615A patent/KR20200051005A/ko not_active Application Discontinuation
- 2018-09-04 JP JP2020513626A patent/JP7218358B2/ja active Active
- 2018-09-04 MX MX2020002556A patent/MX2020002556A/es unknown
- 2018-09-04 US US16/645,080 patent/US11389540B2/en active Active
- 2018-09-04 EP EP18852846.7A patent/EP3678652A4/en active Pending
- 2018-09-04 BR BR112020004502A patent/BR112020004502A8/pt unknown
- 2018-09-04 CA CA3074711A patent/CA3074711A1/en active Pending
- 2018-09-04 CN CN201880058214.0A patent/CN111065387B/zh active Active
- 2018-09-04 AU AU2018328038A patent/AU2018328038B2/en active Active
- 2018-09-04 WO PCT/US2018/049309 patent/WO2019050816A1/en active Application Filing
- 2018-09-04 CN CN202311033166.9A patent/CN117018172A/zh active Pending
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2020
- 2020-03-05 MX MX2022009928A patent/MX2022009928A/es unknown
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2022
- 2022-06-24 US US17/848,462 patent/US11964023B2/en active Active
- 2022-06-24 US US17/848,456 patent/US11759523B2/en active Active
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2023
- 2023-01-25 JP JP2023009333A patent/JP2023052619A/ja active Pending
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- 2024-03-07 AU AU2024201517A patent/AU2024201517A1/en active Pending
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