HRP20210591T1 - Rekombinantna zika cjepiva - Google Patents
Rekombinantna zika cjepiva Download PDFInfo
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- HRP20210591T1 HRP20210591T1 HRP20210591TT HRP20210591T HRP20210591T1 HR P20210591 T1 HRP20210591 T1 HR P20210591T1 HR P20210591T T HRP20210591T T HR P20210591TT HR P20210591 T HRP20210591 T HR P20210591T HR P20210591 T1 HRP20210591 T1 HR P20210591T1
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- protein
- nucleic acid
- zika virus
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- 208000020329 Zika virus infectious disease Diseases 0.000 title 1
- 229960005486 vaccine Drugs 0.000 title 1
- 241000907316 Zika virus Species 0.000 claims 35
- 150000007523 nucleic acids Chemical class 0.000 claims 31
- 101710204837 Envelope small membrane protein Proteins 0.000 claims 26
- 101710145006 Lysis protein Proteins 0.000 claims 26
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 26
- 239000012634 fragment Substances 0.000 claims 15
- 241000712079 Measles morbillivirus Species 0.000 claims 10
- 108010052285 Membrane Proteins Proteins 0.000 claims 9
- 102000018697 Membrane Proteins Human genes 0.000 claims 9
- 239000002245 particle Substances 0.000 claims 9
- 230000002163 immunogen Effects 0.000 claims 8
- 208000015181 infectious disease Diseases 0.000 claims 8
- 230000002458 infectious effect Effects 0.000 claims 8
- 241000700605 Viruses Species 0.000 claims 7
- 238000002360 preparation method Methods 0.000 claims 7
- 108010076504 Protein Sorting Signals Proteins 0.000 claims 6
- 125000000539 amino acid group Chemical group 0.000 claims 6
- 210000004027 cell Anatomy 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- 108020004707 nucleic acids Proteins 0.000 claims 5
- 102000039446 nucleic acids Human genes 0.000 claims 5
- 238000000746 purification Methods 0.000 claims 4
- 239000004475 Arginine Substances 0.000 claims 3
- 239000000427 antigen Substances 0.000 claims 3
- 102000036639 antigens Human genes 0.000 claims 3
- 108091007433 antigens Proteins 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 2
- 230000035772 mutation Effects 0.000 claims 2
- 241000710831 Flavivirus Species 0.000 claims 1
- 241000287828 Gallus gallus Species 0.000 claims 1
- 201000005505 Measles Diseases 0.000 claims 1
- 101710172711 Structural protein Proteins 0.000 claims 1
- 150000001413 amino acids Chemical group 0.000 claims 1
- 238000004587 chromatography analysis Methods 0.000 claims 1
- 230000001605 fetal effect Effects 0.000 claims 1
- 210000002950 fibroblast Anatomy 0.000 claims 1
- 210000005265 lung cell Anatomy 0.000 claims 1
- 210000001161 mammalian embryo Anatomy 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 238000005498 polishing Methods 0.000 claims 1
- 238000000926 separation method Methods 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 210000003501 vero cell Anatomy 0.000 claims 1
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/155—Paramyxoviridae, e.g. parainfluenza virus
- A61K39/165—Mumps or measles virus
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Claims (11)
1. Imunogeni pripravak koji sadrži najmanje jednu zaraznu česticu virusa ospica, pri čemu zarazna čestica virusa sadrži okosnicu vektora virusa ospica i E-protein Zika virusa ili funkcionalni ulomak E-proteina Zika virusa, pri čemu zarazna čestica virusa ospica sadrži kao svoj genom dvije sekvence nukleinske kiseline, pri čemu je prva sekvenca nukleinske kiseline sekvenca koja kodira E-protein Zika virusa ili funkcionalni ulomak E-proteina Zika virusa, te pri čemu je prva sekvenca nukleinske kiseline operativno povezana s drugom sekvencom nukleinske kiseline koja sadrži okosnicu vektora virusa ospica, pri čemu imunogeni pripravak po izboru sadrži najmanje jedan farmaceutski i/ili veterinarski prihvatljiv nosač i/ili pomoćnu tvar,
pri čemu imunogeni pripravak ne sadrži daljnju sekvencu nukleinske kiseline koja kodira ne-strukturni protein flavivirusa; i
(a) pri čemu jedna prva sekvenca nukleinske kiseline sadrži, u uzastopnom nizu,
(i) sekvencu nukleinske kiseline koja kodira dva bazična aminokiselinska ostatka, pri čemu dva bazična aminokiselinska ostatka imaju sekvencu arginin-arginin,
(ii) sekvencu koja kodira signalnu sekvencu za pred-membranski protein Zika virusa ili za funkcionalni ulomak pred-membranskog proteina Zika virusa,
(iii) sekvencu koja kodira pred-membranski protein Zika virusa ili njegov funkcionalni ulomak,
(iv) sekvencu nukleinske kiseline koja kodira signalnu sekvencu za E-protein E-proteina Zika virusa ili za funkcionalni ulomak E-proteina Zika virusa, i
(v) sekvencu nukleinske kiseline koja kodira E-protein Zika virusa ili funkcionalni ulomak E-proteina Zika virusa, i
(vi) pri čemu prva sekvenca nukleinske kiseline ne sadrži sekvencu koja kodira regiju stabljika-sidro E-proteina Zika virusa, ili heterolognu regiju stabljika-sidro za E-protein Zika virusa; ili
(b1) pri čemu prva sekvenca nukleinske kiseline sadrži, u uzastopnom nizu,
(i) sekvencu nukleinske kiseline koja kodira dva bazična aminokiselinska ostatka, pri čemu dva bazična aminokiselinska ostatka imaju sekvencu arginin-arginin,
(ii) sekvencu koja kodira signalnu sekvencu za pred-membranski protein Zika virusa ili za funkcionalni ulomak pred-membranskog proteina Zika virusa,
(iii) sekvencu koja kodira pred-membranski protein Zika virusa ili njegov funkcionalni ulomak,
(iv) sekvencu nukleinske kiseline koja kodira signalnu sekvencu za E-protein E-proteina Zika virusa ili za funkcionalni ulomak E-proteina Zika virusa, i
(v) sekvencu nukleinske kiseline koja kodira E-protein Zika virusa ili njegov funkcionalni ulomak koji ima mutaciju na aminokiselinskom položaju 107 u usporedbi sa sekvencama SEQ ID NO:40 do 52 ili 130 do 150 koje predstavljaju divlji tip E-proteina Zika virusa, i
(vi) sekvencu nukleinske kiseline koja sadrži sekvencu koja kodira regiju stabljika-sidro E-proteina Zika virusa, ili heterolognu regiju stabljika-sidro za E-protein Zika virusa; ili
(b2) pri čemu je prva sekvenca nukleinske kiseline kako je definirana u (b1) i sadrži mutaciju L107D u usporedbi sa sekvencama SEQ ID NO:40 do 52 ili 130 do 150 u E-proteinu Zika virusa ili njegovom funkcionalnom ulomku kodiranom s prvom sekvencom nukleinske kiseline; ili
(c) pri čemu prva sekvenca nukleinske kiseline sadrži, u uzastopnom nizu,
(i) sekvencu nukleinske kiseline koja kodira dva bazična aminokiselinska ostatka, pri čemu dva bazična aminokiselinska ostatka imaju sekvencu arginin-arginin,
(ii) sekvencu koja kodira signalnu sekvencu za pred-membranski protein Zika virusa ili za funkcionalni ulomak pred-membranskog proteina Zika virusa,
(iii) sekvencu koja kodira pred-membranski protein Zika virusa ili njegov funkcionalni ulomak,
(iv) sekvencu nukleinske kiseline koja kodira signalnu sekvencu za E-protein E-proteina Zika virusa ili za funkcionalni ulomak E-proteina Zika virusa,
(v) sekvencu nukleinske kiseline koja kodira E-protein Zika virusa ili funkcionalni ulomak E-proteina Zika virusa, i
(vi) sekvencu nukleinske kiseline koja sadrži sekvencu koja kodira regiju stabljika-sidro E-proteina Zika virusa, ili heterolognu regiju stabljika-sidro za E-protein Zika virusa,
pri čemu prva sekvenca nukleinske kiseline sadrži sekvencu odabranu iz skupine koja se sastoji od sekvenci SEQ ID NO: 53 do 56, ili sekvencu koja ima najmanje 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% ili 99% identičnosti sekvence s njom, pod uvjetom da homologna sekvenca još uvijek kodira najmanje jedan funkcionalni antigen Zika virusa.
2. Imunogeni pripravak u skladu s patentnim zahtjevom 1, naznačen time što je vektorska okosnica iz oslabljenog soja virusa ospica, te je soj virusa ospica odabran iz skupine koju čine soj Schwarz, soj Zagreb, soj AIK-C i soj Moraten, poželjno pri čemu vektorska okosnica sadrži sekvencu prema bilo kojoj od SEQ ID NO: 59, 60 ili 192.
3. Imunogeni pripravak prema bilo kojem od patentnih zahtjeva 1 ili 2, naznačen time što imunogeni pripravak sadrži sekvencu odabranu iz skupine koja se sastoji od sekvenci SEQ ID NO: 53 do 58 ili sekvencu nukleinske kiseline koja ima najmanje 93%, 94%, 95%, 96%, 97%, 98% ili 99% identičnosti sekvence s njom, pod uvjetom da homologna sekvenca, po izboru nakon ekspresije, još uvijek kodira najmanje jedan funkcionalni antigen Zika virusa.
4. Molekula nukleinske kiseline, naznačena time što sadrži prvu sekvencu nukleinske kiseline kako je definirana u patentnom zahtjevu 1 dio (a), (b1), (b2), ili (c).
5. Molekula nukleinske kiseline prema patentnom zahtjevu 4, naznačen time što je prva sekvenca nukleinske kiseline odabrana iz skupine koja se sastoji od sekvenci SEQ ID NO: 53 do 56 ili sekvence koja ima najmanje 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% ili 99% identičnosti sekvence s njom, pod uvjetom da sekvenca nakon ekspresije i dalje kodira funkcionalni antigen Zika virusa.
6. Zarazna čestica virusa ospica kako je definirana u patentnom zahtjevu 1.
7. Stanica domaćina, naznačena time što sadrži molekulu nukleinske kiseline u skladu s patentnim zahtjevima 4 ili 5, ili sadrži zaraznu česticu virusa ospica prema patentnom zahtjevu 6.
8. Postupak za proizvodnju zarazne čestice virusa ospica prema patentnom zahtjevu 6, ili za proizvodnju imunogenog pripravka prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time što postupak sadrži sljedeće korake:
(i) umetanje prve sekvence nukleinske kiseline kako je definirana u patentnom zahtjevu 1 dio (a), (b1), (b2), ili (c) u okosnicu vektora ospica kako je definirano u zahtjevima 1 i 2 radi operativnog povezivanja sekvence nukleinske kiseline i okosnice vektora radi dobivanja rekombinantne kimerne sekvence virusa;
(ii) inficiranje najmanje jedne stanice domaćina s najmanje jednom rekombinantnom kimernom sekvencom virusa dobivenom u koraku (i) radi dobivanja uzorka virusa;
(iii) razjašnjavanje uzorka virusa iz koraka (ii);
(iv) pročišćavanje razjašnjenog uzorka virusa iz koraka (iii);
(v) po izboru: formuliranje najmanje jednog rekombinantnog kimernog virusa s najmanje jednim farmaceutski i/ili veterinarski prihvatljivim nosačem i/ili pomoćnom tvari;
(vi) dobivanje zarazne čestice virusa ospica ili imunogenog pripravka.
9. Postupak prema patentnom zahtjevu 8, naznačen time što obuhvaća korak pročišćavanja (iv), pri čemu stupanj pročišćavanja obuhvaća pročišćavanje kromatografijom, po mogućnosti, pri čemu pročišćavanje slijedi dodatni korak poliranja.
10. Postupak prema patentnom zahtjevu 8 ili 9, naznačen time što je stanica domaćina odabrana iz skupine koja se sastoji od Vero stanica, stanica fibroblasta pilećeg embrija, HEK293 stanica, HeLa stanica, fetalnih rezus plućnih stanica ili MRC5 stanica.
11. Postupak prema bilo kojem od patentnih zahtjeva 8 do 10, naznačen time što postupak obuhvaća daljnji korak koji sadrži
(vii) odvajanje rekombinantnih subvirusnih čestica iz zaraznih čestica.
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| EP16162688.2A EP3184118B1 (en) | 2015-12-23 | 2016-03-29 | Recombinant zika vaccines |
| EP16826738.3A EP3393505B1 (en) | 2015-12-23 | 2016-12-23 | Recombinant zika vaccines |
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| TW201628649A (zh) | 2014-10-09 | 2016-08-16 | 再生元醫藥公司 | 減少醫藥調配物中微可見顆粒之方法 |
| WO2017015463A2 (en) | 2015-07-21 | 2017-01-26 | Modernatx, Inc. | Infectious disease vaccines |
| US11364292B2 (en) | 2015-07-21 | 2022-06-21 | Modernatx, Inc. | CHIKV RNA vaccines |
| WO2017070624A1 (en) | 2015-10-22 | 2017-04-27 | Modernatx, Inc. | Tropical disease vaccines |
| BR112018075513A2 (pt) * | 2016-06-13 | 2019-10-01 | Us Health | ácidos nucleicos que codificam as partículas seme-lhantes ao vírus da zika e seu uso nas vacinas e no ensaio de diagnóstico do vírus da zika |
| WO2017221076A1 (en) * | 2016-06-24 | 2017-12-28 | Institut Pasteur | Compositions and methods comprising measles virus defective interfering particles for the prevention of infectious diseases |
| AU2017301918B2 (en) * | 2016-07-27 | 2022-07-14 | Hawaii Biotech Inc. | Optimized Zika virus envelope gene and expression thereof |
| GB201613191D0 (en) * | 2016-07-29 | 2016-09-14 | Univ Oxford Innovation Ltd | Zika virus vaccine |
| CA3031742A1 (en) | 2016-08-16 | 2018-02-22 | Regeneron Pharmaceuticals, Inc. | Methods for quantitating individual antibodies from a mixture |
| CN109923411B (zh) | 2016-10-25 | 2022-05-31 | 里珍纳龙药品有限公司 | 用于色谱数据分析的方法和系统 |
| WO2018151816A1 (en) | 2017-02-16 | 2018-08-23 | Modernatx, Inc. | High potency immunogenic compositions |
| EP3412307A1 (en) * | 2017-06-07 | 2018-12-12 | Institut Pasteur | Recombinant measles virus expressing zika virus proteins and their applications |
| US10653767B2 (en) | 2017-09-14 | 2020-05-19 | Modernatx, Inc. | Zika virus MRNA vaccines |
| CN111201042B (zh) | 2017-09-19 | 2024-05-10 | 里珍纳龙药品有限公司 | 减少粒子形成的方法以及由其形成的组合物 |
| US11730802B2 (en) | 2017-11-03 | 2023-08-22 | Takeda Vaccines, Inc. | Zika vaccines and immunogenic compositions, and methods of using the same |
| JP2021505549A (ja) | 2017-11-30 | 2021-02-18 | タケダ ワクチン, インコーポレイテッドTakeda Vaccines, Inc. | ジカワクチン及び免疫原性組成物、ならびにその使用方法 |
| CN107987136A (zh) * | 2017-12-13 | 2018-05-04 | 清华大学 | Zikv-ns1蛋白及其在制备寨卡病毒传播阻断疫苗中的应用 |
| US11254953B2 (en) | 2018-04-18 | 2022-02-22 | Utah State University | Compositions and methods for zika virus characterization and vaccine development |
| EP3581646A1 (en) | 2018-06-15 | 2019-12-18 | Themis Bioscience GmbH | Integrated manufacturing and chromatographic system for virus production |
| JP7566637B2 (ja) | 2018-07-02 | 2024-10-15 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 混合物からポリペプチドを調製するための複数の疎水性相互作用クロマトグラフィーの使用 |
| US20220047691A1 (en) * | 2018-10-17 | 2022-02-17 | Texas Tech University System | Multivalent Virus Like Particle Vaccines |
| KR101966841B1 (ko) | 2018-12-12 | 2019-04-08 | 대한민국 | 지카바이러스 e 단백질 유래의 재조합 항원 및 이의 용도 |
| EP3673917A1 (en) * | 2018-12-28 | 2020-07-01 | Themis Bioscience GmbH | Norovirus vaccines |
| US12070495B2 (en) | 2019-03-15 | 2024-08-27 | Modernatx, Inc. | HIV RNA vaccines |
| CN109943536B (zh) * | 2019-03-26 | 2021-09-14 | 昆明理工大学 | 一种戊型肝炎病毒的培养方法及其灭活疫苗的制备方法 |
| US20220213504A1 (en) * | 2019-05-21 | 2022-07-07 | The Regents Of The University Of California | Zika Virus Constructs and Therapeutic Compositions Thereof |
| WO2021158815A1 (en) * | 2020-02-05 | 2021-08-12 | New York Blood Center, Inc. | Zika virus immunogenic compositions |
| CN111875680A (zh) * | 2020-08-08 | 2020-11-03 | 武汉圣润生物科技有限公司 | 一种预防新型冠状病毒微颗粒的制备方法及应用 |
| EP3957650A1 (en) | 2020-08-17 | 2022-02-23 | Themis Bioscience GmbH | Co-stimulatory 4-1bbl ectodomain polypeptides for immunomodulation |
| CN113322282A (zh) * | 2021-04-20 | 2021-08-31 | 华南农业大学 | 稳定表达NS1蛋白的犬肾细胞系MDCK-pCDH-NS1及其构建方法和应用 |
| WO2023250054A1 (en) * | 2022-06-23 | 2023-12-28 | Merck Sharp & Dohme Llc | Immunogenic compositions for epstein-barr virus proteins |
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| US7569383B2 (en) | 2001-06-01 | 2009-08-04 | Acambis Inc. | Chimeric flavivirus vectors |
| EP1375512B1 (en) | 2002-06-20 | 2009-07-22 | Institut Pasteur | Infectious cDNA of an approved vaccine strain of measles virus. Use for immunogenic compositions |
| 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 |
| FR2870126B1 (fr) | 2004-05-17 | 2009-07-17 | Pasteur Institut | Vecteur lentiviral recombinant d'expression d'une proteine de flaviviridae et ses applications comme vaccin |
| CA2614322A1 (en) * | 2005-07-14 | 2007-01-25 | Mayo Foundation For Medical Education And Research | Paramyxoviridae virus preparations |
| EA014062B1 (ru) * | 2005-11-01 | 2010-08-30 | Новартис Вэксинс Энд Диагностикс Гмбх & Ко Кг | Вирусные вакцины, полученные из клеток с низкими уровнями остаточной клеточной днк |
| EP1939214B1 (en) | 2006-12-22 | 2013-07-10 | Institut Pasteur | Cells and methodology to generate non-segmented negative-strand RNA viruses |
| AU2012326079B2 (en) * | 2011-10-20 | 2017-01-12 | The Government Of The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services | Dengue virus E-glycoprotein polypeptides containing mutations that eliminate immunodominant cross-reactive epitopes |
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| EP2712871A1 (en) | 2012-09-27 | 2014-04-02 | Institut Pasteur | Recombinant Measles virus expressing Chikungunya virus polypeptides and their applications |
| US9267114B2 (en) | 2012-11-07 | 2016-02-23 | Southern Research Institute | Flavivirus envelope protein mutations affecting virion disassembly |
| WO2016130786A2 (en) * | 2015-02-15 | 2016-08-18 | Integral Molecular, Inc. | Flaviviridae proteins and virions and methods of use thereof |
| WO2016145149A1 (en) * | 2015-03-11 | 2016-09-15 | The United States Of America, As Represented By The Secretary Of The Army, On Behalf Of The Walter Reed Army Institute Of Research | Combination purified inactivated vaccine for flaviviruses |
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2016
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- 2016-12-23 LT LTEP16826738.3T patent/LT3393505T/lt unknown
- 2016-12-23 PL PL16826738T patent/PL3393505T3/pl unknown
- 2016-12-23 PT PT168267383T patent/PT3393505T/pt unknown
- 2016-12-23 EP EP21165273.0A patent/EP3903814A1/en active Pending
- 2016-12-23 SG SG10202004516VA patent/SG10202004516VA/en unknown
- 2016-12-23 HU HUE16826738A patent/HUE054847T2/hu unknown
- 2016-12-23 RS RS20210601A patent/RS61939B1/sr unknown
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- 2016-12-23 EP EP16826738.3A patent/EP3393505B1/en active Active
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- 2016-12-23 ES ES16826738T patent/ES2867954T3/es active Active
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- 2016-12-23 MX MX2018007860A patent/MX2018007860A/es unknown
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- 2016-12-23 DK DK16826738.3T patent/DK3393505T3/da active
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2018
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2021
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| US11110162B2 (en) | 2021-09-07 |
| WO2017109211A1 (en) | 2017-06-29 |
| DK3393505T3 (da) | 2021-05-10 |
| PT3393505T (pt) | 2021-04-28 |
| RS61939B1 (sr) | 2021-07-30 |
| SG10202004516VA (en) | 2020-06-29 |
| PL3393505T3 (pl) | 2021-10-25 |
| WO2017109211A9 (en) | 2017-07-20 |
| HUE054847T2 (hu) | 2021-10-28 |
| EP3184118B1 (en) | 2020-05-06 |
| ZA201804071B (en) | 2020-01-29 |
| WO2017109222A1 (en) | 2017-06-29 |
| ZA201804735B (en) | 2019-05-29 |
| LT3393505T (lt) | 2021-05-25 |
| SI3393505T1 (sl) | 2021-08-31 |
| EP3184118A1 (en) | 2017-06-28 |
| US20190083601A1 (en) | 2019-03-21 |
| CY1124202T1 (el) | 2022-05-27 |
| EP3184119A1 (en) | 2017-06-28 |
| EP3903814A1 (en) | 2021-11-03 |
| EP3393505A1 (en) | 2018-10-31 |
| MX2018007860A (es) | 2018-11-09 |
| BR112018012962A2 (pt) | 2018-12-04 |
| US10894079B2 (en) | 2021-01-19 |
| ES2867954T3 (es) | 2021-10-21 |
| SG11201804496UA (en) | 2018-07-30 |
| EP3393513B1 (en) | 2021-04-21 |
| EP3393505B1 (en) | 2021-03-31 |
| US20180371426A1 (en) | 2018-12-27 |
| EP3393513A1 (en) | 2018-10-31 |
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