KR20090088429A - E형 간염 바이러스의 폴리펩티드 단편, 그를 이용한 백신 조성물 및 진단용 키트 - Google Patents
E형 간염 바이러스의 폴리펩티드 단편, 그를 이용한 백신 조성물 및 진단용 키트 Download PDFInfo
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- KR20090088429A KR20090088429A KR1020097013830A KR20097013830A KR20090088429A KR 20090088429 A KR20090088429 A KR 20090088429A KR 1020097013830 A KR1020097013830 A KR 1020097013830A KR 20097013830 A KR20097013830 A KR 20097013830A KR 20090088429 A KR20090088429 A KR 20090088429A
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Abstract
Description
Claims (22)
- 서열번호 1에 나타난 E형 간염 바이러스 ORF2의 아미노산 서열의 단편을 포함하거나 상기 서열로 구성되는 폴리펩티드로, 상기 단편은 다음의 폴리펩티드들로 구성된 군에서 선택되는 것인 폴리펩티드:a) 서열번호 1의 아미노산 잔기 113 및 469 사이에서 개시하는 아미노 말단, 및 서열번호 1의 아미노산 잔기 596 및 660 사이에서 종결하는 카르복실 말단을 갖는 폴리펩티드;b) 서열번호 1의 아미노산 잔기 414 내지 660의 아미노산 서열을 갖는 폴리펩티드, 즉, 폴리펩티드 247;c) 서열번호 1의 아미노산 잔기 429 내지 660의 아미노산 서열을 갖는 폴리펩티드, 즉, 폴리펩티드 232;d) 서열번호 1의 아미노산 잔기 439 내지 660의 아미노산 서열을 갖는 폴리펩티드, 즉, 폴리펩티드 222;e) 서열번호 1의 아미노산 잔기 459 내지 660의 아미노산 서열을 갖는 폴리펩티드, 즉, 폴리펩티드 201;f) 상기 전술한 a) 내지 e)의 폴리펩티드 중 어느 하나와 적어도 80%의 상동성을 가지며, 항원성 또는 면역원성이 실질적으로 동일한 폴리펩티드.
- 정제된 모노머 폴리펩티드의 다량체로, 상기 다량체는 2 내지 180개의 모노 머 폴리펩티드의 자기 응집에 의해 형성된 것이고, 상기 각 정제된 모노머 폴리펩티드는 제1항에 따른 폴리펩티드인, 다량체.
- 제1항에 따른 폴리펩티드 중 적어도 하나 또는 제2항에 따른 다량체, 또는 이들의 조합, 또는 제2항에 따른 다량체 중 적어도 하나 또는 이들의 조합, 및 선택적으로, 약학적으로 허용 가능한 담체 및/또는 아쥬반트를 포함하는, 포유류에서의 E형 간염 바이러스 감염의 예방 및/또는 치료용 백신 조성물.
- 제1항에 따른 폴리펩티드와 인플루엔자 바이러스 유래의 적혈구 응집원의 보존적 단편을 포함하는 키메릭 단백질.
- 정제된 모노머 폴리펩티드의 다량체로, 상기 다량체는 2 내지 180개의 정제된 모노머 폴리펩티드의 자기 응집에 의해 형성된 것이고, 상기 각각의 정제된 모노머 폴리펩티드는 제4항의 키메릭 단백질인, 다량체.
- 제4항에 따른 키메릭 단백질 또는 제5항에 따른 다량체, 및 선택적으로 약학적으로 허용되는 담체 및/또는 아쥬반트를 포함하는, 포유류에서의 E형 간염 바이러스 감염의 예방 및/또는 치료용 백신 조성물.
- 제1항에 따른 폴리펩티드와 E형 간염 바이러스 ORF3의 면역원성 에피토프 또 는 이들의 면역원성 단편을 포함하는 키메릭 단백질.
- 정제된 모노머 폴리펩티드의 다량체로, 상기 다량체는 2 내지 180개의 정제된 모노머 폴리펩티드의 자기 응집에 의해 형성된 것이고, 상기 각 정제된 모노머 폴리펩티드는 제1항에 따른 폴리펩티드와 E형 간염 바이러스 ORF3의 면역원성 에피토프 또는 이들의 면역원성 단편을 포함하는 것인, 다량체.
- 제7항에 따른 키메릭 단백질 또는 제8항에 따른 다량체, 및 선택적으로, 약학적으로 허용되는 담체 및/또는 아쥬반트를 포함하는, 포유류에서의 E형 간염 바이러스 감염의 예방 및/또는 치료용 백신 조성물.
- 제1항에 따른 폴리펩티드, 제4항에 따른 키메릭 단백질 또는 제7항에 따른 키메릭 단백질을 코딩하는 뉴클레오타이드 서열을 포함하는 재조합 발현 벡터.
- 제1항에 따른 폴리펩티드, 제4항에 따른 키메릭 단백질 또는 제7항에 따른 키메릭 단백질을 각각 발현할 수 있는, 제10항에 따른 재조합 발현 벡터로 형질전환된 숙주 세포.
- 제1항에 따른 폴리펩티드의 적어도 하나 또는 이들의 조합 또는 제2항에 따른 다량체 중 적어도 하나 또는 이들의 조합을 진단 유효량으로 포함하는, 생물학 적 샘플에서의 E형 간염 바이러스의 감염을 진단하기 위한 진단 키트.
- E형 간염 바이러스 ORF3의 면역학적 에피토프 또는 이들의 면역학적 단편을 함유하는 폴리펩티드를 추가로 포함하는 제12항에 따른 진단 키트로서, 상기 폴리펩티드는 E형 간염 바이러스 OFR3의 면역학적 에피토프 또는 이들의 면역학적 단편을 포함하고, 선택적으로 제1항에 따른 선택된 폴리펩티드에 공유적으로 결합되어 있는, 진단 키트.
- 제1항에 따른 폴리펩티드 또는 제2항에 따른 다량체 중 적어도 하나를 포함하고, 필요할 경우, 상기 폴리펩티드는 적절한 지지체의 표면상에 예비-코팅되어 있는 것이고; IgG에 대하여 검출 대상 생물학적 샘플로부터 얻은 검출 가능하게 표지된 항-IgG 항체, 및 상기 검출 가능한 표지에 대응하는 검출 시약을 추가적으로 포함하고, 필요할 경우, 적절한 버퍼 시스템을 추가적으로 포함하는, 생물학적 샘플에서의 E형 간염 바이러스에 대한 항체 IgG의 측정용 제12항 또는 제13항에 따른 진단 키트.
- 포획 항체(capture antibody)로서 IgM에 대하여 검출 대상 생물학적 샘플로부터 얻은 검출 가능하게 표지된 항-IgM 항체를 포함하고, 필요할 경우, 상기 포획 항체가 적절한 지지체 표면 상에 예비-코팅되어 있고, 검출 가능하게 표지된 제1항에 따른 폴리펩티드 또는 제2항에 따른 다량체 중 적어도 하나, 및 상기 검출 가능 한 표지에 대응하는 검출 시약을 포함하고, 필요하면, 적절한 버퍼 시스템을 추가적으로 포함하는, 생물학적 샘플에서의 E형 간염 바이러스에 대한 항체 IgM의 측정용 제12항 또는 제13항에 따른 진단 키트.
- 제1항에 따른 폴리펩티드 또는 제2항에 따른 다량체 중 적어도 하나를 포함하고, 필요하다면, 상기 펩타이드는 적절한 지지체의 표면 상에 예비-코팅되어 있고; 제1항에 따른 검출 가능하게 표지된 폴리펩티드 또는 제2항에 따른 다량체의 적어도 하나, 및 상기 검출 가능한 라벨에 대응하는 검출 시약을 추가로 포함하고; 지지체의 표면에 예비-코팅을 위한 상기 폴리펩티드 또는 다량체와 검출가능하게 표지된 폴리펩티드 또는 다량체는 동일하거나, 서로 다른 것일 수 있는, 생물학적 샘플에서의 E형 간염 바이러스에 대한 전체 항체의 측정용 제12항 또는 제13항에 따른 진단 키트.
- 제1항에 따른 폴리펩티드 또는 제2항에 따른 다량체 중 적어도 하나를 지지체 표면에 고정시키는 단계; 항원 항체 상호작용을 위한 조건 하에서 이를 검출대상 샘플과 접촉시키는 단계; 적절한 버퍼로 세척하는 단계; 및 검출 가능한 표지를 갖는 E형 간염 바이러스 항원 및 대응 검출 시약을 사용하여 지지체 표면에서 항원/항체 복합체를 검출하는 단계를 포함하는, 생물학적 샘플에서의 E형 간염 바이러스에 대한 전체 항체의 검출 방법.
- 제1항에 따른 폴리펩티드 또는 제2항에 따른 다량체 중 적어도 하나를 지지체 표면에 고정시키는 단계; 항원 항체 상호작용을 위한 조건하에서 이를 검출 대상 샘플과 접촉시키는 단계; 버퍼로 세척하는 단계; 및 검출 가능하게 표지된 E형 간염 바이러스에 대한 항-IgG 항체 및 대응 검출 시약을 사용하여 지지체 표면에서 항원/항체 복합체를 검출하는 단계를 포함하는, 생물학적 샘플에서의 E형 간염 바이러스에 대한 항체 IgG의 검출 방법.
- 항-IgM 항체를 지지체 표면에 고정시키는 단계; 항원 항체 상호작용을 위한조건하에서 이를 검출 대상 샘플과 접촉시키는 단계; 적절한 버퍼로 세척하는 단계; 및 검출 가능하게 표지된 제1항에 따른 폴리펩티드 또는 제2항에 따른 다량체 중 적어도 하나, 및 대응 검출 시약을 사용하여 지지체 표면에서 항-IgM/IgM 복합체를 검출하는 단계를 포함하는, 생물학적 샘플에서의 E형 간염 바이러스에 대한 항체 IgM의 검출 방법.
- 항-IgM 항체를 지지체 표면에 고정시키는 단계; 항원 항체 상호작용을 위한 조건하에서 이를 검출 대상 샘플과 접촉시키는 단계; 버퍼로 세척하는 단계; 그리고 나서, 항원 항체 상호작용을 위한 조건하에서 제1항에 따른 폴리펩티드 또는 제2항에 따른 다량체 중 적어도 하나와 접촉시키는 단계; 버퍼로 세척하는 단계; 및 검출 가능하게 표지된 항-HEV 폴리클로날 또는 모노클로날 항체 및 대응 검출 시약을 사용하여 지지체 표면에서 항원/항체 복합체를 검출하는 단계를 포함하는, 생물학적 샘플에서의 E형 간염 바이러스에 대한 항체 IgM의 검출 방법.
- 제4항에 따른 키메릭 단백질 또는 제5항에 따른 다량체를 포함하는, 생물학적 샘플 내에서 E형 간염 바이러스의 감염을 진단 또는 생물학적 샘플 내에서 E 형 간염 바이러스에 대한 항체 IgG, 항체 IgM, 전체 항체의 검출을 위한 진단 키트.
- 제7항에 따른 키메릭 단백질 또는 제8항에 따른 다량체를 포함하는, 생물학적 샘플 내에서 E형 간염 바이러스의 감염을 진단 또는 생물학적 샘플 내에서 E 형 간염 바이러스에 대한 항체 IgG, 항체 IgM, 전체 항체의 검출을 위한 진단 키트.
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PCT/CN2001/001469 WO2002040681A1 (fr) | 2000-09-30 | 2001-09-30 | Fragment polypeptidique du virus de l'hepatite e, composition vaccinale contenant ledit fragment, agent diagnostic et leurs applications |
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CN101367869B (zh) * | 2000-09-30 | 2012-12-05 | 北京万泰生物药业股份有限公司 | 用于预防、诊断及治疗戊型肝炎病毒的多肽,及它们作为诊断试剂和疫苗 |
JP2005524386A (ja) * | 2001-11-08 | 2005-08-18 | ▲養▼生堂有限公司 | 抗e型肝炎ウイルスモノクローナル抗体、又は結合性を有するそのフラグメント、及びそれらの使用 |
CN1850855B (zh) * | 2006-05-26 | 2012-08-29 | 厦门大学 | 用于免疫或制备单克隆抗体的方法和组合物 |
JP5869885B2 (ja) * | 2009-02-27 | 2016-02-24 | ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア | E型肝炎ウイルス様粒子を用いた多抗原送達系 |
US8906863B2 (en) | 2009-02-27 | 2014-12-09 | The Regents Of The University Of California | Proteolysis-resistant capsid of chimeric hepatitis E virus as an oral delivery vector |
US8906862B2 (en) | 2009-02-27 | 2014-12-09 | The Regents Of The University Of California | Multiple antigen delivery system using hepatitis E virus-like particle |
EP2612206A1 (en) * | 2010-08-31 | 2013-07-10 | ABB Technology AG | Method for debugging of process or manufacturing plant solutions comprising multiple sub-systems |
CN102453748A (zh) * | 2010-10-18 | 2012-05-16 | 北京雅康博生物科技有限公司 | 用于荧光定量pcr定量检测的质粒标准品 |
CN102565410B (zh) * | 2012-01-12 | 2014-08-06 | 吉林大学 | 一种梅花鹿朊蛋白免疫学检测方法 |
CN104519909A (zh) * | 2012-05-09 | 2015-04-15 | 巴拉特生物技术国际有限公司 | 疫苗组合物 |
CN104031144B (zh) * | 2013-03-05 | 2017-08-25 | 厦门大学 | 特异结合戊型肝炎病毒3、4型的抗体及其用途 |
CN104789534B (zh) * | 2015-04-10 | 2017-10-17 | 浙江中医药大学 | 一种杂交瘤、单克隆抗体及其用途 |
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WO2017202973A1 (en) * | 2016-05-25 | 2017-11-30 | Intervet International B.V. | Hev vaccine |
KR101924093B1 (ko) | 2017-04-18 | 2018-11-30 | 건국대학교 산학협력단 | E형 간염 바이러스 유전자형 3 및 4 진단용 프라이머 세트 및 이를 이용한 진단 방법 |
CN110501505B (zh) * | 2018-05-18 | 2022-06-10 | 中国兽医药品监察所 | 小反刍兽疫诊断试剂盒 |
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US20210269510A1 (en) * | 2018-07-10 | 2021-09-02 | Inserm (Institut National De La Santè Et De La Recherch Médicale | Antibodies having specificity for the orf2i protein of hepatitis e virus and uses thereof for diagnostic purposes |
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EP2298793A2 (en) | 2011-03-23 |
KR100927221B1 (ko) | 2009-11-16 |
JP5681337B2 (ja) | 2015-03-04 |
JP5829830B2 (ja) | 2015-12-09 |
WO2002040681A1 (fr) | 2002-05-23 |
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KR20030048052A (ko) | 2003-06-18 |
US20100150962A1 (en) | 2010-06-17 |
AU2002220460A1 (en) | 2002-05-27 |
US20100143410A1 (en) | 2010-06-10 |
BRPI0114510B1 (pt) | 2019-09-03 |
BR0114510A (pt) | 2004-02-17 |
EP1331271B1 (en) | 2014-03-19 |
EP1331271A4 (en) | 2005-04-06 |
EP1331271A1 (en) | 2003-07-30 |
CN101367869B (zh) | 2012-12-05 |
US20040052813A1 (en) | 2004-03-18 |
KR101121754B1 (ko) | 2012-03-23 |
EP2298793A3 (en) | 2011-06-29 |
JP2014138593A (ja) | 2014-07-31 |
US8715695B2 (en) | 2014-05-06 |
US7615228B2 (en) | 2009-11-10 |
CN101367869A (zh) | 2009-02-18 |
MXPA03002751A (es) | 2004-05-04 |
JP2004525613A (ja) | 2004-08-26 |
CN1345775A (zh) | 2002-04-24 |
BRPI0114510B8 (pt) | 2021-05-25 |
JP2011201881A (ja) | 2011-10-13 |
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