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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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.
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
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US201361875068P | 2013-09-08 | 2013-09-08 | |
US61/875,068 | 2013-09-08 | ||
US201461926717P | 2014-01-13 | 2014-01-13 | |
US61/926,717 | 2014-01-13 | ||
US201461989432P | 2014-05-06 | 2014-05-06 | |
US61/989,432 | 2014-05-06 | ||
PCT/IB2014/064091 WO2015033251A2 (en) | 2013-09-08 | 2014-08-27 | Neisseria meningitidis compositions and methods thereof |
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EP (2) | EP3041502A2 (ru) |
JP (5) | JP6177206B2 (ru) |
KR (4) | KR20210002757A (ru) |
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AU (4) | AU2014316722B2 (ru) |
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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. |
WO2012025873A2 (en) | 2010-08-23 | 2012-03-01 | Wyeth Llc | STABLE FORMULATIONS OF NEISSERIA MENINGITIDIS rLP2086 ANTIGENS |
PE20140173A1 (es) | 2010-09-10 | 2014-02-20 | Wyeth Llc | Variantes no lipidadas de antigenos orf2086 de neisseria meningitidis |
SA115360586B1 (ar) | 2012-03-09 | 2017-04-12 | فايزر انك | تركيبات لعلاج الالتهاب السحائي البكتيري وطرق لتحضيرها |
SG10201602558UA (en) | 2012-03-09 | 2016-05-30 | Pfizer | Neisseria meningitidis compositions and methods thereof |
EP2964665B1 (en) | 2013-03-08 | 2018-08-01 | Pfizer Inc | Immunogenic fusion polypeptides |
CA2923129C (en) * | 2013-09-08 | 2020-06-09 | Pfizer Inc. | Neisseria meningitidis compositions and methods thereof |
BR112017017460A2 (pt) * | 2015-02-19 | 2018-04-10 | Pfizer Inc. | composições de neisseria meningitidis e métodos das mesmas |
AU2018215585B2 (en) | 2017-01-31 | 2022-03-17 | Pfizer Inc. | Neisseria meningitidis compositions and methods thereof |
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