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RU2508126C2 - Композиции для иммунизации против staphylococcus aureus - Google Patents

Композиции для иммунизации против staphylococcus aureus Download PDF

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RU2508126C2
RU2508126C2 RU2011146016/15A RU2011146016A RU2508126C2 RU 2508126 C2 RU2508126 C2 RU 2508126C2 RU 2011146016/15 A RU2011146016/15 A RU 2011146016/15A RU 2011146016 A RU2011146016 A RU 2011146016A RU 2508126 C2 RU2508126 C2 RU 2508126C2
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Фабио Баньоли
Массимильяно БИЯДЖИНИ
Луиджи ФЬЯСКИ
Гвидо ГРАНДИ
Рави МИШРА
Натали НОРАИС
Мария СКАРСЕЛЛИ
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Новартис Аг
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Abstract

Группа изобретений относится к эффективным иммуногенным композициям против Staphylococcus aureus, которые включают антигенные компоненты sta006, индуцирующий антитело, которое распознает SEQ ID NO:42; и содержащий аминокислотную последовательность: имеющую 50% или более идентичность SEQ ID NO:42; и/или содержащую фрагмент из, по меньшей мере, «n» последовательных аминокислот SEQ ID NO:42, где «n» составляет 7 или более, и sta011, индуцирующий антитело, которое распознает SEQ ID NO:47; и содержащий аминокислотную последовательность: имеющую 50% или более идентичность SEQ ID NO:47; и/или содержащую фрагмент из, по меньшей мере, «n» последовательных аминокислот SEQ ID NO:47, где «n» составляет 7 или более. Данные антигенные компоненты необязательно могут применяться в комбинации с сахаридами S. aureus. Композиции, включающие заявленные антигены, вызывают защитный иммунный ответ против нескольких патологий, вызванных S. Aureus. 2 н. и 11 з.п. ф-лы, 19 ил., 3 табл.

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Claims (13)

1. Иммуногенная композиция, включающая комбинацию антигенов, где указанная комбинация включающая
антиген sta006, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 42; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 42; и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 42, где n составляет 7 или более; и антиген sta011, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 47 и (ii) содержит аминокислотную последовательность: (a) имеющую 50% или более идентичность SEQ ID NO: 47 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 47, где n составляет 7 или более.
2. Композиция по п.1, дополнительно содержащая
антиген hla, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 14; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 14; и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 14, где n составляет 7 или более; антиген hla, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 14; и (ii) содержит аминокислотную последовательность: (a) имеющую 50% или более идентичность SEQ ID NO: 14 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 14, где n составляет 7 или более; и антиген isdA, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 17; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 17 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 17, где n составляет 7 или более;
антиген hla, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 14; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 14; и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 14, где n составляет 7 или более; и антиген spa, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 36; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 36 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 36, где n составляет 7 или более;
антиген spa, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 36; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 36 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 36, где n составляет 7 или более;
антиген sta019, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 55; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 55 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 55, где n составляет 7 или более; антиген sta019, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 55; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 55 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 55, где n составляет 7 или более; и антиген hla, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 14; и (ii) содержит аминокислотную последовательность: (a) имеющую 50% или более идентичность SEQ ID NO: 14 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 14, где n составляет 7 или более;
антиген esxA, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 10; и (ii) содержит аминокислотную последовательность: (a) имеющую 50% или более идентичность SEQ ID NO: 10 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 10, где n составляет 7 или более; и антиген esxB, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 11; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 11 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 11, где n составляет 7 или более; или
антиген esxA, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 10; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 10 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 10, где n составляет 7 или более; и антиген esxB, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 11; и (ii) содержит аминокислотную последовательность: (а) имеющую 50% или более идентичность SEQ ID NO: 11 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 11, где n составляет 7 или более; и антиген hla, который: (i) индуцирует антитело, которое распознает SEQ ID NO: 14; и (ii) содержит аминокислотную последовательность: (a) имеющую 50% или более идентичность SEQ ID NO: 14 и/или (b) содержащую фрагмент из, по меньшей мере, n последовательных аминокислот SEQ ID NO: 14, где n составляет 7 или более.
3. Композиция по п.1, где:
антиген sta006 содержит аминокислотную последовательность, имеющую 60, 70, 80, 90% или более идентичность SEQ ID NO: 42;
антиген sta011 содержит аминокислотную последовательность, имеющую 60, 70, 80, 90% или более идентичность SEQ ID NO: 47;
антиген hla содержит аминокислотную последовательность, имеющую 60, 70, 80, 90% или более идентичность SEQ ID NO: 14;
антиген esxA содержит аминокислотную последовательность, имеющую 60, 70, 80, 90% или более идентичность SEQ ID NO: 10; и/или антиген esxB содержит аминокислотную последовательность, имеющую 60, 70, 80, 90% или более идентичность SEQ ID NO: 11.
4. Композиция по п.1, где:
антиген sta006 содержит аминокислотную последовательность, имеющую 90% или более идентичность SEQ ID NO: 246;
антиген sta011 содержит аминокислотную последовательность, имеющую 90% или более идентичность SEQ ID NO: 247; и/или
антиген hla содержит аминокислотную последовательность, имеющую 90% или более идентичность SEQ ID NO: 231.
5. Композиция по п.2-4, где антигены esxA и esxB экспрессируются в виде одиночной полипептидной цепи, которая содержит аминокислотную последовательность, имеющую 80% или более идентичность SEQ ID NO: 151 или 152.
6. Композиция по п.1, содержащая: (i) где антиген sta006 содержит аминокислотную последовательность, имеющую 99% или более идентичность SEQ ID NO: 248; (ii) антиген sta011 содержит аминокислотную последовательность, имеющую 99% или более идентичность SEQ ID NO: 249; (iii) антиген hla содержит аминокислотную последовательность, имеющую 99% или более идентичность SEQ ID NO: 232; и (iv) антигены esxA и esxB содержат аминокислотную последовательность, имеющую 99% или более идентичность SEQ ID NO: 250.
7. Композиция по п.1, где один или более указанных антигенов адсорбированы на адъюванте гидроксиде алюминия.
8. Композиция по п.1, где композиция включает гистидиновый буфер или фосфатный буфер.
9. Композиция по п.1, имеющая рН 5.0-8.1.
10. Композиция по п.1, дополнительно включающая: один или более конъюгатов
(i) экзополисахарида S. aureus и белка-носителя и/или
(ii) капсулярного полисахарида S. aureus и белка-носителя.
11. Композиция по п.1, находящаяся в лиофилизованной форме.
12. Композиция по п.1, находящаяся в водной форме.
13. Фармацевтическая композиция для лечения или предотвращения одной или более патологий, вызванных инфекцией S. aureus, включающая композицию по любому из предшествующих пунктов и фармацевтический носитель и/или эксципиент.
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