JP2012528791A - ヒト防御用組換えサブユニット西ナイルウイルスワクチン - Google Patents
ヒト防御用組換えサブユニット西ナイルウイルスワクチン Download PDFInfo
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Abstract
Description
配列表
米国政府援助研究に関する陳述
発明の分野
発明の背景
西ナイルウイルスエンベロープタンパク質サブユニット(WN−80E)
アラム
投与法及び使用法
実施例
実施例1
ショウジョウバエS2系における西ナイル80Eタンパク質の発現及び精製
発現プラスミドpMttbns(pMttPA由来)は、次のエレメント:キイロショウジョウバエ(Drosophila melanogasteer)のメタロチオネインプロモーター、ヒト組織プラスミノーゲン活性化因子分泌リーダー(tPAL)及びSV40初期ポリアデニル化信号を有している。Hawaii Biotechにおいて、現存するユニークなBglIIサイトに加えてユニークなXhoIサイトを含むpMttΔXhoを産生するために、pMttbnsベクターから14塩基対のBamHI断片を切除した。この発現ベクターは、発現タンパク質の培養液への分泌を促進する。これらのユニークなBglII及びXhoIサイトを使用して、西ナイル配列をpMttΔXhoベクターに導入した。カルボキシ切断西ナイルエンベロープタンパク質を発現するために、西ナイルウイルス由来のprMタンパク質全体及びEタンパク質のアミノ酸1−401をコードする合成遺伝子を合成した(Midland Certified Reagens Co.社製,ミッドランド、テキサス州)。合成遺伝子のヌクレオチド配列は、1999年にニューヨーク市で単離された西ナイルウイルスの公表された配列に従っている。Eタンパク質のアミノ酸401でのEタンパク質のC末端切断は、膜貫通ドメインを除去しており、それ故に培地に分泌することができる。最終のprM80Eプラスミド構築物はpMttWNprM80Eと命名した。S2細胞内で発現するとすぐprM配列は、宿主のプロテアーゼによって80E配列から切断される。401のアミノ酸からなるWN−80E組換えサブユニットタンパク質は培養液に分泌される。WN−80Eタンパク質のアミノ酸配列を図1に示す。
実施例2
臨床試験を支援するためのcGMP下でのWN−80Eの生産
実施例3
臨床試験用HBV−002ワクチンの製剤化
実施例4
HBV−002西ナイル組換えサブユニットワクチンの臨床試験
参考文献
Bancroft,W.H.et al.,(1984)Vaccine149:1005−10
Barrett,ADT and Teuwen,DE,(2009)Curr.Opin.Immunol.21:308−313
Beasley,D.et al.,(2004)Vaccine22:3722−26
Ben−Nathan et al.,(2003)J.Inf.Dis.188:5−12
Bray,M.et al.,(1996)J.Virol.70:4162−66
Bray,M. and Lai,C.J.(1991)Proc.Natl.Acad.Sci.USA88:10342−46
Chambers,T.J.et al.,(1990)Annual Rev. Microbiol.44:649−88
Chen,W.et al.,(1995)J.Virol.69:5186−90
Chowers et al.,(2001)Emerg.Inf.Dis.7:675−78
Comment(2004)Ann.Inter.Med.141:153
Culp,J.S.et al.,(1991)Biotechnology9:173−7
Cuzzubbo et al.,(2001)Clin.Diagn.Lab.Immunol.8:1150−55
Diamond,M.S.et al.,(2008)Immunol.Rev.225:212−225
Eckels,K.H.,and Putnak,R.(2003)Adv.Virus Res.61:395−418
Heinz,F.X.et al.,(1983)Virology130:485−501
Henchal,E.A.et al.,(1985)Am.J. Trop.Med.Hyg.34:162−69
Henchal,E.A.and Putnak J.R.(1990)Clin.Microbiol Rev.3:376−96
Ivey−Hoyle,M.(1991)Curr.Opin.Biotechnol.2:704−7
Ivy,J.et al.,米国特許第6,432,411号
Johansen,H.et al.,(1989)Genes Dev.3:882−89
Kimura−Kiroda,J.and K.Ysui(1988)J.Immunol.141:3606−10
Klee et al.,(2004)Emerg.Inf.Dis.10:1405−11
Kreil et al.,(1998)J.Virol.72:3076−3081
Lai,C.J.et al.,(1998)Clin.Diagn.Virol.10:173−79
Lai,C.J.and Monath,T.P.(2003)Adv.Virus Res.61:469−509
Lieberman,M.et al.(2008)Vaccine25:414−23
Lieberman,M.et al.(2009)Clin.Vaccine Immunol.16:1332−37
Markoff,L.(2000)Vaccine18:26−32
Martin,J.E.et al.,(2007)J.Infect.Dis.196:1732−40
Mason,P.W.(1989)J.Gen.Virol.70:2037−48
McDonell et al.,米国特許第6,416,763号
McKee,K.T.et al.,(1987)Am.J.Trop.Med.Hyg.36:435−42
Modis,Y.et al.,(2003)Proc.Natl.Acad.Sci.USA100:6986−91
Modis,Y.et al.,(2004)Nature427:313−9
Monath,T.P.,et al.,(2006)Proc.Natl.Acad.Sci.USA103:6694
Morbidity and Mortality Weekly Report(MMWR)(2004)vol.53,Nov19,2004
Morbidity and Mortality Weekly Report(MMWR)(2008)vol.57:720−23
Morrey,J.D.et al., J.Inf.Dis.194:1300−8
Murphy et al.,(1986)J.Clin.Microbiol.24:197−202
Platonov et al.,(2001)Emerg.Inf.Dis.7:128−32
Pletnev et al.,(2002)Proc.Natl.Acad.Sci.USA99:3036−41
Putnak,R.,et al.,(2003)Adv.Virus Res.61:445−68
Review(2003)Am.J.Trop.Med.Hyg.69Supplement:1−60
Sanchez et al.,(2006)FEMS Immunol.Med.Microbiol.24:4914−26
Siirin,M.T.et al.,(2008)Am.J.Trop.Med.Hyg.79:955−62
Claims (10)
- 精製組換え西ナイルウイルスエンベロープ(「E」)タンパク質の有効量、ここで当該Eタンパク質はそのN末端のアミノ酸残基1から始まる野生型Eの長さの約80%を構成し(WN−80E)、その結果前記Eタンパク質は、宿主細胞において組換えで発現するとき増殖培地中に分泌可能となる;及びアルミニウムベースアジュバントの有効量を含むワクチンであって、ここでヒト対象において中和抗体の生産を誘導する当該ワクチン。
- Eタンパク質が昆虫宿主細胞において組換えで生産及び発現される請求項1記載のワクチン。
- Eタンパク質がキイロショウジョウバエシュナイダー2(S2)(Drosophila melanogaster Schneider2)宿主細胞において組換えで生産及び発現される請求項1記載のワクチン。
- 薬学的に許容可能な賦形剤をさらに含む請求項1、2又は3記載のワクチン。
- 免疫不全個体群における使用のための請求項1、2又は3記載のワクチン。
- 請求項1、2又は3記載のワクチンの治療的有効量を治療的に許容可能な方法で投与することを含む人間における防御免疫応答を高める方法。
- 請求項1、2及び3記載のワクチンの有効量を投与しそれによって西ナイル病からの防御を提供することを含む西ナイルウイルス誘発疾病に対するヒト免疫防御を提供する方法。
- 免疫不全の個体群における使用のための請求項4記載のワクチン。
- 請求項4記載のワクチンの治療的有効量を治療的に許容可能な方法で投与することを含む人間における防御免疫応答を高める方法。
- 請求項4記載のワクチンの有効量を投与しそれによって西ナイル病からの防御を提供することを含む西ナイルウイルス誘発疾病に対するヒト免疫防御を提供する方法。
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US18275409P | 2009-05-31 | 2009-05-31 | |
US61/182,754 | 2009-05-31 | ||
PCT/US2010/001608 WO2010141084A2 (en) | 2009-05-31 | 2010-06-01 | Recombinant subunit west nile virus vaccine for protections of human subjects |
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JP2012528791A true JP2012528791A (ja) | 2012-11-15 |
JP2012528791A5 JP2012528791A5 (ja) | 2013-01-10 |
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JP2012513062A Pending JP2012528791A (ja) | 2009-05-31 | 2010-06-01 | ヒト防御用組換えサブユニット西ナイルウイルスワクチン |
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US (2) | US20120141520A1 (ja) |
EP (1) | EP2437778B1 (ja) |
JP (1) | JP2012528791A (ja) |
CN (1) | CN102481355A (ja) |
AU (1) | AU2010257162B2 (ja) |
CA (1) | CA2761262C (ja) |
WO (1) | WO2010141084A2 (ja) |
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WO2016097861A1 (en) * | 2014-12-19 | 2016-06-23 | Distalmotion Sa | Sterile interface for articulated surgical instruments |
WO2017037532A1 (en) | 2015-08-28 | 2017-03-09 | Distalmotion Sa | Surgical instrument with increased actuation force |
EP3481407A4 (en) | 2016-07-08 | 2020-04-01 | Hawaii Biotech, Inc. | VACCINE AGAINST WEST NILE VIRUS AND METHOD OF USE |
US11844585B1 (en) | 2023-02-10 | 2023-12-19 | Distalmotion Sa | Surgical robotics systems and devices having a sterile restart, and methods thereof |
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WO2006115548A2 (en) * | 2005-04-25 | 2006-11-02 | Hawaii Biotech, Inc. | Subunit vaccine against west nile viral infection |
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DE69624815T2 (de) | 1995-05-24 | 2003-07-10 | Hawaii Biotech Group | Untereinheitsimpfstoff gegen flavivirus infektion |
US6136561A (en) | 1995-05-24 | 2000-10-24 | Hawaii Biotechnology Group, Inc. | Methods of preparing carboxy-terminally truncated recombinant flavivirus envelope glycoproteins employing drosophila melanogaster expression systems |
US6416763B1 (en) | 1998-08-28 | 2002-07-09 | Hawaii Biotechnology Group, Inc. | Recombinant nonstructural protein subunit vaccine against flaviviral infection |
US6432411B1 (en) | 1999-07-13 | 2002-08-13 | Hawaii Biotechnology Group | Recombinant envelope vaccine against flavivirus infection |
US20040213808A1 (en) * | 2002-12-11 | 2004-10-28 | Michael Lieberman | Recombinant vaccine against flavivirus infection |
CA2432738A1 (en) * | 2003-02-26 | 2004-08-26 | Philippe Despres | New dengue and west nile viruses proteins and genes coding the foregoing, and their use in vaccinal, therapeutic and diagnostic applications |
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- 2010-06-01 JP JP2012513062A patent/JP2012528791A/ja active Pending
- 2010-06-01 US US13/322,784 patent/US20120141520A1/en not_active Abandoned
- 2010-06-01 AU AU2010257162A patent/AU2010257162B2/en active Active
- 2010-06-01 EP EP10783708.0A patent/EP2437778B1/en active Active
- 2010-06-01 CA CA2761262A patent/CA2761262C/en active Active
- 2010-06-01 WO PCT/US2010/001608 patent/WO2010141084A2/en active Application Filing
- 2010-06-01 CN CN2010800239506A patent/CN102481355A/zh active Pending
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WO2006115548A2 (en) * | 2005-04-25 | 2006-11-02 | Hawaii Biotech, Inc. | Subunit vaccine against west nile viral infection |
Non-Patent Citations (2)
Title |
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JPN6014024695; VACCINE VOL.27, 2009, P.213-222 * |
JPN6014024696; 'VIEW OF NCT00707642 ON 2008_12_01' CLINICALTRIALS.GOV ARCHIVE , 20081201 * |
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US20120141520A1 (en) | 2012-06-07 |
US20170165349A1 (en) | 2017-06-15 |
CA2761262C (en) | 2020-01-07 |
CA2761262A1 (en) | 2010-12-09 |
CN102481355A (zh) | 2012-05-30 |
US10039820B2 (en) | 2018-08-07 |
EP2437778A4 (en) | 2013-07-24 |
AU2010257162A1 (en) | 2011-12-01 |
WO2010141084A3 (en) | 2011-03-03 |
AU2010257162B2 (en) | 2014-12-04 |
EP2437778A2 (en) | 2012-04-11 |
EP2437778B1 (en) | 2019-07-31 |
WO2010141084A2 (en) | 2010-12-09 |
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