CN100374151C - 产生免疫的药物组合物及其在制备预防和治疗致淀粉样病的药物中的用途 - Google Patents
产生免疫的药物组合物及其在制备预防和治疗致淀粉样病的药物中的用途 Download PDFInfo
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- CN100374151C CN100374151C CNB988117312A CN98811731A CN100374151C CN 100374151 C CN100374151 C CN 100374151C CN B988117312 A CNB988117312 A CN B988117312A CN 98811731 A CN98811731 A CN 98811731A CN 100374151 C CN100374151 C CN 100374151C
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Abstract
Description
未处理 | PBS | AN1792 | |||||||
月龄 | 总Aβ | Aβ42 | (n) | 总Aβ | Aβ42 | (n) | 总Aβ | Aβ42 | (n) |
121518 | 1,6008,70022,200 | 13008,30018,500 | (10)(10)(10) | 8,60019,000 | 7,20015,900 | (9)(12) | 1,6005,200<sup>**</sup> | 1,300<sup>*</sup>4,000<sup>**</sup> | (10)(9) |
未治疗 | PBS | AN1792 | |||||||
月龄 | 总Aβ | Aβ42 | (n) | 总Aβ | Aβ42 | (n) | 总Aβ | Aβ42 | (n) |
121518 | 15,50051,50080,800 | 11,10044,40064,200 | (10)(10)(10) | 40,10065,400 | 35,70057,100 | (9)(12) | 24,50050,900<sup>*</sup> | 22,10038,900<sup>**</sup> | (10)(9) |
未治疗 | PBS | AN1792 | ||||
月龄 | 总Aβ | (n) | 总Aβ | (n) | 总Aβ | (n) |
121518 | 15.627.735.0 | (10)(10)(10) | 20.843.1 | (9)(12) | 21.724.8<sup>*</sup> | (10)(9) |
表5 | |||
免疫原 | 共轭物 | Aβ氨基酸 | 应答数 |
Aβ1-5 | 是 | 5-聚体 | 0/7 |
Aβ1-12 | 是 | 12-聚体 | 1/8 |
Aβ13-28 | 是 | 16-聚体 | 1/9 |
Aβ25-35 | 11-聚体 | 1/9 | |
Aβ33-42 | 是 | 10-聚体 | 0/10 |
Aβ1-40 | 40-聚体 | 5/8 | |
Aβ1-42 | 42-聚体 | 9/9 | |
r Aβ1-42 | 42-聚体 | 8/8 | |
pBx6 | 0/8 | ||
PBS | 0-聚体 | 0/8 |
抗体 | 表位 |
2H3 | Aβ1-12 |
10D5 | Aβ1-12 |
266 | Aβ13-28 |
21F12 | Aβ33-42 |
小鼠多克隆抗人Aβ42 | 抗聚集态Aβ42 |
丁氢萘心定研究010的实验设计 | |||||
组 | N<sup>a</sup> | 佐剂<sup>b</sup> | 剂量 | 抗原 | 剂量(μg) |
1 | 10 | MPL | 12.5μg | AN1792 | 33 |
2 | 10 | MPL | 25μg | AN1792 | 33 |
3 | 10 | MPL | 50μg | AN1792 | 33 |
4 | 13 | MPL | 125μg | AN1792 | 33 |
5 | 13 | MPL | 50μg | AN1792 | 150 |
6 | 13 | MPL | 50μg | AN1528 | 33 |
7 | 10 | PBS | AN1792 | 33 | |
8 | 10 | PBS | 无 | ||
9 | 10 | 角鲨烯乳化 | 5% | AN1792 | 33 |
10 | 10 | 角鲨烯混合 | 5% | AN1792 | 33 |
11 | 10 | 明矾 | 2mg | AN1792 | 33 |
12 | 13 | MPL+明矾 | 50μg/2mg | AN1792 | 33 |
13 | 10 | QS21 | 5μg | AN1792 | 33 |
14 | 10 | QS21 | 10μg | AN1792 | 33 |
15 | 10 | QS21 | 25μg | AN1792 | 33 |
16 | 13 | QS21 | 25μg | AN1792 | 150 |
17 | 13 | QS21 | 25μg | AN1528 | 33 |
18 | 13 | QS21+MPL | 25μg/50μg | AN1792 | 33 |
19 | 13 | QS21+明矾 | 25μg/2mg | AN1792 | 33 |
抗体的几何平均效价 | |||||
取血周数 | |||||
治疗组 | 2.9 | 5.0 | 8.7 | 12.9 | 16.7 |
1 | 248 | 1797 | 2577 | 6180 | 4177 |
2 | 598 | 3114 | 3984 | 5287 | 6878 |
3 | 1372 | 5000 | 7159 | 12333 | 12781 |
4 | 1278 | 20791 | 14368 | 20097 | 25631 |
5 | 3288 | 26242 | 13229 | 9315 | 23742 |
6 | 61 | 2536 | 2301 | 1442 | 4504 |
7 | 37 | 395 | 484 | 972 | 2149 |
8 | 25 | 25 | 25 | 25 | 25 |
9 | 25 | 183 | 744 | 952 | 1823 |
10 | 25 | 89 | 311 | 513 | 817 |
11 | 29 | 708 | 2618 | 2165 | 3666 |
12 | 198 | 1458 | 1079 | 612 | 797 |
13 | 38 | 433 | 566 | 1080 | 626 |
14 | 104 | 541 | 3247 | 1609 | 838 |
15 | 212 | 2630 | 2472 | 1224 | 1496 |
16 | 183 | 2616 | 6680 | 2085 | 1631 |
17 | 28 | 201 | 375 | 222 | 1540 |
18 | 31699 | 15544 | 23095 | 6412 | 9059 |
19 | 63 | 243 | 554 | 299 | 441 |
抗体的几何平均效价<sup>a</sup> | |||||
取血周数 | |||||
治疗 | 3.3 | 5.0 | 9.0 | 13.0 | 17.0 |
明矾/AN1792 | 102(12/21)<sup>b</sup> | 1,081(17/20) | 2,366(21/21) | 1,083(19/21) | 572(18/21) |
MPL/AN1792 | 6241(21/21) | 28,867(21/21) | 1,1242(21/21) | 5,665(20/20) | 8,204(20/20) |
QS21/AN1792 | 30(1/20) | 227(10/19) | 327(10/19) | 1,511(17/18) | 1,188(14/18) |
CFA/AN1792 | 10,076(15/15) | 61,279(15/15) | 75,386(15/15) | 41,628(15/15) | 30,574(15/15) |
明矾/AN1528 | 25(0/21) | 33(1/21) | 39(3/20) | 37(1/21) | 31(2/20) |
MPL/AN1528 | 184(15/21) | 2,591(20/21) | 1,653(21/21) | 1,156(20/20) | 3,099(20/20) |
QS21/AN1528 | 29(1/22) | 221(13/22) | 51(4/22) | 820(20/22) | 2,994(21/22) |
PBS+硫柳汞 | 25(0/16) | 33(2/16) | 39(4/16) | 37(3/16) | 47(4/16) |
PBS | 25(0/16) | 25(0/16) | 25(0/15) | 25(0/12) | 25(0/16) |
表1 | |||||||||
50%最大光密度时的效价 | |||||||||
聚集态Aβ注射的小鼠 | |||||||||
PDAPP的月龄 | 小鼠100 | 小鼠101 | 小鼠102 | 小鼠103 | 小鼠104 | 小鼠105 | 小鼠106 | 小鼠107 | 小鼠108 |
4 | 70000 | 150000 | 15000 | 120000 | 1000 | 15000 | 50000 | 80000 | 100000 |
6 | 15000 | 65000 | 30000 | 55000 | 300 | 15000 | 15000 | 50000 | 60000 |
8 | 20000 | 55000 | 50000 | 50000 | 400 | 15000 | 18000 | 50000 | 60000 |
10 | 40000 | 20000 | 60000 | 50000 | 900 | 15000 | 50000 | 20000 | 40000 |
12 | 25000 | 30000 | 60000 | 40000 | 2700 | 20000 | 70000 | 25000 | 20000 |
两种免疫原的PBS注射小鼠 | |||||||||
效价为1/100 | |||||||||
PDAPP的月龄 | 小鼠113 | 小鼠114 | 小鼠115 | 小鼠116 | 小鼠117 | ||||
6 | <4x bkg | <4x bkg | <4x bkg | <4x bkg | <4x bkg | ||||
10 | 5x bkg | <4x bkg | <4x bkg | <4x bkg | <4x bkg | ||||
12 | <4x bkg | <4x bkg | <4x bkg | <4x bkg | <4x bkg |
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1999
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2000
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