RU2016108139A - Композиция neisseria meningitidis и способ индуцирования иммунного ответа - Google Patents
Композиция neisseria meningitidis и способ индуцирования иммунного ответа Download PDFInfo
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- 238000000034 method Methods 0.000 title claims 17
- 241000588650 Neisseria meningitidis Species 0.000 title claims 11
- 230000028993 immune response Effects 0.000 title claims 10
- 230000001939 inductive effect Effects 0.000 title claims 5
- 229920001184 polypeptide Polymers 0.000 claims 21
- 102000004196 processed proteins & peptides Human genes 0.000 claims 21
- 108090000765 processed proteins & peptides Proteins 0.000 claims 21
- 230000000844 anti-bacterial effect Effects 0.000 claims 18
- 241000282412 Homo Species 0.000 claims 13
- 210000002966 serum Anatomy 0.000 claims 12
- 150000001413 amino acids Chemical group 0.000 claims 10
- 230000000405 serological effect Effects 0.000 claims 9
- 108060003951 Immunoglobulin Proteins 0.000 claims 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 8
- 102000018358 immunoglobulin Human genes 0.000 claims 8
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 5
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 4
- 229910052782 aluminium Inorganic materials 0.000 claims 4
- 230000000295 complement effect Effects 0.000 claims 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- 230000002163 immunogen Effects 0.000 claims 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 4
- 229940068968 polysorbate 80 Drugs 0.000 claims 4
- 229920000053 polysorbate 80 Polymers 0.000 claims 4
- 239000011780 sodium chloride Substances 0.000 claims 4
- 201000005702 Pertussis Diseases 0.000 claims 3
- 208000000474 Poliomyelitis Diseases 0.000 claims 3
- 206010043376 Tetanus Diseases 0.000 claims 3
- 206010013023 diphtheria Diseases 0.000 claims 3
- 102000037865 fusion proteins Human genes 0.000 claims 3
- 108020001507 fusion proteins Proteins 0.000 claims 3
- 241000701806 Human papillomavirus Species 0.000 claims 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- 101710186862 Factor H binding protein Proteins 0.000 claims 1
- 201000009906 Meningitis Diseases 0.000 claims 1
- 241000588653 Neisseria Species 0.000 claims 1
- 241001631646 Papillomaviridae Species 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
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- C07K14/22—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Neisseriaceae (F)
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Claims (41)
1. Композиция, содержащая
a) первый липидированный полипептид, содержащий аминокислотную последовательность, представленную SEQ ID NO: 1,
b) второй липидированный полипептид, содержащий аминокислотную последовательность, представленную SEQ ID NO: 2,
2. Композиция по п. 1, дополнительно содержащая полисорбат-80, алюминий, гистидин и хлорид натрия.
3. Композиция по п. 2, при этом композиция содержит приблизительно 120 мкг/мл первого полипептида; приблизительно 120 мкг/мл второго полипептида; с молярным соотношением полисорбата-80 приблизительно 2,8; приблизительно 0,5 мг/мл алюминия; приблизительно 10 мМ гистидина; и приблизительно 150 мМ хлорида натрия.
4. Композиция по п. 2, при этом композиция содержит приблизительно 60 мкг первого полипептида; приблизительно 60 мкг второго полипептида; приблизительно 18 мкг полисорбата-80; приблизительно 250 мкг алюминия; приблизительно 780 мкг гистидина; и приблизительно 4380 мкг хлорида натрия.
5. Композиция по п. 1, при этом композиция индуцирует бактерицидный титр иммуноглобулина сыворотки, который, по меньшей мере, больше, чем в 1 раз выше у человека после введения первой дозы, чем бактерицидный титр иммуноглобулина сыворотки у человека до получения первой дозы, при определении в идентичных условиях в бактерицидном анализе сыворотки с использованием комплемента человека.
6. Композиция по п. 1, при этом композиция индуцирует бактерицидный титр иммуноглобулина сыворотки, который, по меньшей мере, в 2 раза выше у человека после введения первой дозы, чем бактерицидный титр иммуноглобулина сыворотки у человека до получения первой дозы, при определении в идентичных условиях в бактерицидном анализе сыворотки с использованием комплемента человека.
7. Композиция по п. 1, при этом композиция индуцирует бактерицидный титр иммуноглобулина сыворотки, который, по меньшей мере, в 4 раза выше у человека после введения первой дозы, чем бактерицидный титр иммуноглобулина сыворотки у человека до получения первой дозы, при определении в идентичных условиях в бактерицидном анализе сыворотки с использованием комплемента человека.
8. Композиция по п. 1, при этом композиция индуцирует бактерицидный титр иммуноглобулина сыворотки, который, по меньшей мере, в 8 раз выше у человека после введения первая доза, чем бактерицидный титр иммуноглобулина сыворотки у человека до получения первой дозы, при определении в идентичных условиях в бактерицидном анализе сыворотки с использованием комплемента человека.
9. Композиция по п. 1, при этом композиция дополнительно не содержит полипептид, имеющий меньше чем 100% идентичность последовательности к SEQ ID NO: 1.
10. Композиция по п. 1, в которой первый полипептид имеет всего 258 аминокислот.
11. Композиция по п. 1, в которой первый полипептид содержит аминокислотную последовательность, представленную SEQ ID NO: 3 на N-конце полипептида.
12. Композиция по п. 1, при этом композиция дополнительно не содержит полипептид, имеющий меньше чем 100% идентичность последовательности к SEQ ID NO: 2.
13. Композиция по п. 1, в которой второй полипептид имеет всего 261 аминокислоту.
14. Композиция по п. 1, в которой второй полипептид содержит аминокислотную последовательность, представленную SEQ ID NO: 3 на N-конце полипептида.
15. Композиция по п. 1, при этом композиция содержит не больше, чем два липидированных полипептида.
16. Композиция по п. 1, при этом композиция дополнительно не содержит полипептид, имеющий меньше чем 100% идентичность последовательности к SEQ ID NO: 1.
17. Композиция по п. 1, при этом композиция дополнительно не содержит полипептид, имеющий меньше чем 100% идентичность последовательности к SEQ ID NO: 2.
18. Композиция по п. 1, при этом композиция не содержит гибридный белок.
19. Композиция по п. 1, при этом композиция не содержит химерный белок.
20. Композиция по п. 1, при этом композиция не содержит слитый белок.
21. Композиция по п. 1, при этом композиция не является лиофилизированной.
22. Композиция по п. 1, при этом композиция представляет собой жидкую композицию.
23. Способ индуцирования бактерицидного иммунного ответа против штамма подсемейства А серологической группы В Neisseria meningitidis и против штамма подсемейства В серологической группы В Neisseria meningitidis у человека, который включает введение человеку эффективного количества композиции, где указанная композиция содержит:
a) первый липидированный полипептид, содержащий аминокислотную последовательность, представленную SEQ ID NO: 1, и
b) второй липидированный полипептид, содержащий аминокислотную последовательность, представленную SEQ ID NO: 2.
24. Способ по п. 23, где композиция дополнительно содержит полисорбат-80, алюминий, гистидин и хлорид натрия.
25. Способ по п. 23, в котором иммунный ответ против штамма подсемейства А серологической группы В Neisseria meningitidis больше, чем иммунный ответ против штамма подсемейства В серологической группы В Neisseria meningitidis.
26. Способ по п. 23, в котором иммунный ответ против штамма подсемейства А серологической группы В Neisseria meningitidis у человека содержит бактерицидный титр, который больше, чем бактерицидный титр против штамма подсемейства В серологической группы В Neisseria meningitidis у человека.
27. Способ по п. 23, в котором композиция индуцирует бактерицидный иммунный ответ против какого-либо одного из штаммов N. meningitidis серологической группы В А22, А56, В24, В44, или какой-либо их комбинации.
28. Способ по п. 23, в котором композиция индуцирует бактерицидный иммунный ответ против какого-либо одного из штаммов серологической группы В N. meningitidis В24, В16, В44, А22, В03, В09, А12, А19, А05, А07, В153, или какой-либо их комбинации.
29. Способ по п. 23, где способ дополнительно включает введение человеку иммуногенной композиции против вируса папилломы человека.
30. Способ по п. 29, в котором иммуногенную композицию против вируса папилломы человека вводят человеку в пределах 24 часов от введения указанной композиции против Neisseria meningitidis.
31. Способ по п. 29, который дополнительно включает индуцирование иммунного ответа против какого-либо одного из вирусов папилломы человека типа 6, 11, 16, 18, или какой-либо их комбинации.
32. Способ по п. 23, где способ дополнительно включает введение человеку иммуногенной композиции против дифтерии, столбняка, коклюша и полиомиелита.
33. Способ по п. 32, в котором иммуногенную композицию против дифтерии, столбняка, коклюша и полиомиелита вводят человеку в пределах 24 часов от введения указанной композиции против Neisseria meningitidis.
34. Способ по п. 32, где способ дополнительно включает индуцирование иммунного ответа против какого-либо одного из дифтерии, столбняка, коклюша, полиомиелита, или какой-либо их комбинации у человека.
35. Способ индуцирования бактерицидного иммунного ответа против штамма серологической группы В Neisseria meningitides, экспрессирующего В153 фактор Н связывающий белок у человека, который включает введение человеку эффективного количества композиции, где указанная композиция содержит:
a) первый липидированный полипептид, содержащий аминокислотную последовательность, представленную SEQ ID NO: 1, и
b) второй липидированный полипептид, содержащий аминокислотную последовательность, представленную SEQ ID NO: 2.
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| MX339524B (es) | 2001-10-11 | 2016-05-30 | Wyeth Corp | Composiciones inmunogenicas novedosas para la prevencion y tratamiento de enfermedad meningococica. |
| SI2608805T2 (sl) | 2010-08-23 | 2025-09-30 | Wyeth Llc | Stabilne formulacije antigenov rLP2086 neisserie meningitidis |
| BR112013005329A2 (pt) | 2010-09-10 | 2017-05-02 | Wyeth Llc | variantes não lipidadas de antígenos orf2086 de neisseria meningitidis |
| NZ628449A (en) | 2012-03-09 | 2016-04-29 | Pfizer | Neisseria meningitidis compositions and methods thereof |
| SA115360586B1 (ar) | 2012-03-09 | 2017-04-12 | فايزر انك | تركيبات لعلاج الالتهاب السحائي البكتيري وطرق لتحضيرها |
| JP6446377B2 (ja) | 2013-03-08 | 2018-12-26 | ファイザー・インク | 免疫原性融合ポリペプチド |
| EP3041502A2 (en) * | 2013-09-08 | 2016-07-13 | Pfizer Inc. | Neisseria meningitidis compositions and methods thereof |
| EP3270959A1 (en) * | 2015-02-19 | 2018-01-24 | Pfizer Inc | Neisseria meningitidis compositions and methods thereof |
| JP7010961B2 (ja) | 2017-01-31 | 2022-02-10 | ファイザー・インク | 髄膜炎菌組成物およびその方法 |
| EP4034157A1 (en) * | 2019-09-27 | 2022-08-03 | Pfizer Inc. | Neisseria meningitidis compositions and methods thereof |
| CN114681601B (zh) * | 2020-12-31 | 2025-08-19 | 基础治疗有限公司 | 脑膜炎奈瑟氏球菌疫苗及其应用 |
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