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RU2010111758A - Иммуногенные композиции и способы - Google Patents

Иммуногенные композиции и способы Download PDF

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RU2010111758A
RU2010111758A RU2010111758/10A RU2010111758A RU2010111758A RU 2010111758 A RU2010111758 A RU 2010111758A RU 2010111758/10 A RU2010111758/10 A RU 2010111758/10A RU 2010111758 A RU2010111758 A RU 2010111758A RU 2010111758 A RU2010111758 A RU 2010111758A
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immunogenic peptide
polypeptide according
antigenic epitope
amino acid
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RU2468034C2 (ru
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Джералд В. ФИШЕР (US)
Джералд В. ФИШЕР
Люк Т. ДАУМ (US)
Люк Т. ДАУМ
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ЛОНГХОРН ВЭКСИНС ЭНД ДИАГНОСТИКС ЭлЭлСи (US)
ЛОНГХОРН ВЭКСИНС ЭНД ДИАГНОСТИКС ЭлЭлСи
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Abstract

1. Иммуногенный пептид или полипептид, содержащий ! (a) (i) первый антигенный эпитоп длиной от 6 до приблизительно 70 аминокислот, состоящий из первой аминокислотной последовательности, которая по крайней мере на 95% идентична первой последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16; и (ii) второй антигенный эпитоп длиной от 6 до приблизительно 70 аминокислот, состоящий из второй аминокислотной последовательности, которая по крайней мере на 95% идентична второй последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16; или ! (b) первый и второй антигенный эпитопы, каждый из которых имеет длину от 6 до приблизительно 50 аминокислот и состоит из первой аминокислотной последовательности, которая по крайней мере на 95% идентична аминокислотной последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16. ! 2. Иммуногенный пептид или полипептид по п.1, где патогеном является бактерия, вирус, простейшее, дрожжи или гриб. ! 3. Иммуногенный пептид или полипептид по п.2, в котором первый антигенный эпитоп, по существу, гомологичен по крайней мере первому белку первого вирусного или микробного патогена, а второй антигенный эпитоп, по существу, гомологичен по крайней мере второму белку второго вирусного или микробного патогена. ! 4. Иммуногенный пептид или полипептид по п.1, в котором первый антигенный эпитоп имеет длину от 6 до приблизительно 50 аминокислот и состоит из аминокислотной последовательности, которая по крайней мере на 95% идентична последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16. ! 5. Иммуногенный пептид или полипептид по п.1, в котором каждый из первого и второго антигенных эпитопов содержит по крайней ме�

Claims (24)

1. Иммуногенный пептид или полипептид, содержащий
(a) (i) первый антигенный эпитоп длиной от 6 до приблизительно 70 аминокислот, состоящий из первой аминокислотной последовательности, которая по крайней мере на 95% идентична первой последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16; и (ii) второй антигенный эпитоп длиной от 6 до приблизительно 70 аминокислот, состоящий из второй аминокислотной последовательности, которая по крайней мере на 95% идентична второй последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16; или
(b) первый и второй антигенный эпитопы, каждый из которых имеет длину от 6 до приблизительно 50 аминокислот и состоит из первой аминокислотной последовательности, которая по крайней мере на 95% идентична аминокислотной последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16.
2. Иммуногенный пептид или полипептид по п.1, где патогеном является бактерия, вирус, простейшее, дрожжи или гриб.
3. Иммуногенный пептид или полипептид по п.2, в котором первый антигенный эпитоп, по существу, гомологичен по крайней мере первому белку первого вирусного или микробного патогена, а второй антигенный эпитоп, по существу, гомологичен по крайней мере второму белку второго вирусного или микробного патогена.
4. Иммуногенный пептид или полипептид по п.1, в котором первый антигенный эпитоп имеет длину от 6 до приблизительно 50 аминокислот и состоит из аминокислотной последовательности, которая по крайней мере на 95% идентична последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16.
5. Иммуногенный пептид или полипептид по п.1, в котором каждый из первого и второго антигенных эпитопов содержит по крайней мере, по существу, одинаковую первичную аминокислотную последовательность.
6. Иммуногенный пептид или полипептид по п.1, в котором первый антигенный эпитоп, по существу, гомологичен по крайней мере первому белку двух или более различных видов одного и того же патогена.
7. Иммуногенный пептид или полипептид по п.1, в котором первый антигенный эпитоп специфичен для первого белка или пептида M1, M2, HA, NA, PB1, PB2, PspA, PspC, M2e, НА или NA вируса гриппа, а второй антигенный эпитоп специфичен для второго отличного белка или пептида M1, M2, HA, NA, PB1, PB2, PspA, PspC, M2e, НА или NA вируса гриппа.
8. Иммуногенный пептид или полипептид по п.1, в котором первый антигенный эпитоп специфичен для первого штамма или серотипа вируса гриппа, а второй антигенный эпитоп специфичен для второго отличного штамма или серотипа вируса гриппа.
9. Иммуногенный пептид или полипептид по п.1, в котором первый антигенный эпитоп содержит выделенный антигенный пептид длиной от 6 до приблизительно 30 аминокислот, который состоит из аминокислотной последовательности, которая по крайней мере на 95% идентична последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 или SEQ ID NO: 16, а второй антигенный эпитоп включает выделенный антигенный пептид длиной от 6 до приблизительно 30 аминокислот, который состоит из аминокислотной последовательности, которая по крайней мере на 95% идентична другой последовательности, выбранной из SEQ ID NO: 1, SEQ ID NO: 11 и SEQ ID NO: 16.
10. Иммуногенный пептид или полипептид по п.1, дополнительно содержащий по крайней мере первую последовательность Т-клеточного эпитопа, которая содержит столбнячный анатоксин, дифтерийный анатоксин, полисахарид, липопротеин или их производное или комбинацию.
11. Выделенный полинуклеотид, который кодирует иммуногенный пептид или полипептид по любому пп.1-10.
12. Выделенный полинуклеотид по п.11, содержащийся внутри рекомбинантного экспрессионного вектора.
13. Выделенный полинуклеотид по п.11 или 12, содержащийся внутри рекомбинантного вируса, вириона или вирусной частицы.
14. Выделенное антитело или его антигенсвязывающий фрагмент, которые специфически связываются с иммуногенным пептидом или полипептидом по любому из пп.1-10.
15. Антитело или его антигенсвязывающий фрагмент по п.14, которые выбирают из группы, состоящей из антитела человека, химерного антитела, антигенсвязывающего фрагмента антитела человека, гуманизированного антитела, антигенсвязывающего фрагмента гуманизированного антитела, химерного гуманизированного антитела, антигенсвязывающего фрагмента химерного гуманизированного антитела, поликлональной сыворотки, моноклонального антитела, Fab-фрагмента, Fab'-фрагмента, F(ab')2-фрагмента и Fv-фрагмента.
16. Композиция, содержащая (а) активный иммуногенный компонент, содержащий (i) иммуногенный пептид или полипептид по любому из пп.1-10; (ii) выделенный полинуклеотид по любому из пп.11-13 или (iii) выделенное антитело по п.14 или 15, или любую их комбинацию; и (b) фармацевтически приемлемый буфер, разбавитель или носитель.
17. Композиция по п.16, составленная для введения в клетку-хозяина животного и предпочтительно клетку-хозяина млекопитающего.
18. Композиция по п.16 или 17 для лечения патогенной инфекции у млекопитающего.
19. Композиция по п.16 для применения для диагностики, профилактики или лечения.
20. Применение композиции по любому из пп.16-19 для производства лекарственного средства или вакцины для профилактики или лечения и, в частности, лекарственного средства для диагностики, лечения, предупреждения или уменьшения интенсивности одного или нескольких симптомов вирусной или микробной инфекции у млекопитающего и предпочтительно человека.
21. Способ индукции у животного иммунологической реакции, включающий введение композиции, которая содержит иммуногенный пептид или полипептид по любому из пп.1-10, в количестве, эффективном для индукции иммунологической реакции.
22. Способ профилактики или контроля вспышки гриппозной инфекции в отобранной популяции млекопитающих, включающий введение чувствительному или подверженному риску члену популяции композиции, которая содержит иммуногенный пептид или полипептид по любому из пп.1-10 в количестве, эффективном для предупреждения или контроля вспышки гриппозной инфекции в популяции.
23. Способ стимуляции иммунной системы индивидуума для индукции защитной иммунной реакции против патогенной инфекции, включающий введение индивидууму иммунологически эффективного количества композиции, содержащей иммуногенный пептид или полипептид по любому из пп.1-10 в течение периода времени, который является достаточным для стимулирования иммунной системы индивидуума с индукцией защитной иммунной реакции против патогена.
24. Способ индукции защитной иммунной реакции против вируса гриппа у нуждающегося в этом млекопитающего, включающий введение млекопитающему количества композиции, которая содержит иммуногенный пептид или полипептид по любому из пп.1-10, эффективного для индукции защитной иммунной реакции против вируса гриппа у млекопитающего.
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