JP2018502080A - デングウイルスワクチン組成物およびその使用方法 - Google Patents

デングウイルスワクチン組成物およびその使用方法 Download PDF

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JP2018502080A
JP2018502080A JP2017533387A JP2017533387A JP2018502080A JP 2018502080 A JP2018502080 A JP 2018502080A JP 2017533387 A JP2017533387 A JP 2017533387A JP 2017533387 A JP2017533387 A JP 2017533387A JP 2018502080 A JP2018502080 A JP 2018502080A
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dengue
vaccine
composition
virus
live
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JP2018502080A5 (cg-RX-API-DMAC7.html
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カジミーロ，ダニーロ・アール
ベット，アンドリュー
コラー，ベス−アン・グリスウォールド
ダナセカラーン，ガバインダラジャン
シンタラ，ラメシュ・ブイ
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Merck Sharp and Dohme LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5252—Virus inactivated (killed)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5254—Virus avirulent or attenuated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55577—Saponins; Quil A; QS21; ISCOMS
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24122—New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24171—Demonstrated in vivo effect
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
JP2017533387A 2014-12-22 2015-12-18 デングウイルスワクチン組成物およびその使用方法 Pending JP2018502080A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462095331P 2014-12-22 2014-12-22
US62/095,331 2014-12-22
PCT/US2015/066549 WO2016106107A2 (en) 2014-12-22 2015-12-18 Dengue virus vaccine compositions and methods of use thereof

Publications (2)

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JP2018502080A true JP2018502080A (ja) 2018-01-25
JP2018502080A5 JP2018502080A5 (cg-RX-API-DMAC7.html) 2019-01-31

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US (1) US10449243B2 (cg-RX-API-DMAC7.html)
EP (1) EP3236997B1 (cg-RX-API-DMAC7.html)
JP (1) JP2018502080A (cg-RX-API-DMAC7.html)
CN (1) CN106999568A (cg-RX-API-DMAC7.html)
AU (1) AU2015369875A1 (cg-RX-API-DMAC7.html)
BR (1) BR112017013270A2 (cg-RX-API-DMAC7.html)
CL (1) CL2017001595A1 (cg-RX-API-DMAC7.html)
CO (1) CO2017005830A2 (cg-RX-API-DMAC7.html)
CR (1) CR20170280A (cg-RX-API-DMAC7.html)
ES (1) ES2981476T3 (cg-RX-API-DMAC7.html)
MX (1) MX383329B (cg-RX-API-DMAC7.html)
MY (1) MY192543A (cg-RX-API-DMAC7.html)
NI (1) NI201700080A (cg-RX-API-DMAC7.html)
PH (1) PH12017501165B1 (cg-RX-API-DMAC7.html)
SG (1) SG11201704942QA (cg-RX-API-DMAC7.html)
WO (1) WO2016106107A2 (cg-RX-API-DMAC7.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170143817A1 (en) * 2015-11-20 2017-05-25 Oregon Health & Science University Dengue virus vaccine
TWI625393B (zh) * 2016-11-15 2018-06-01 國立清華大學 對抗複數種登革熱病毒血清型之疫苗套組及其製備方法與用途
CN111447947B (zh) 2017-12-07 2024-01-12 默沙东有限责任公司 登革病毒疫苗组合物的制剂
CN114302737A (zh) * 2019-05-20 2022-04-08 索利吉尼克斯公司 制造三价线状病毒疫苗的组合物和方法
WO2025027616A1 (en) * 2023-08-01 2025-02-06 Serum Institute Of India Private Limited Freeze-dried viral vaccine compositions and method of manufacturing thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100104598A1 (en) * 2006-08-15 2010-04-29 The Government Of The U.S.A., As Represented By The Secretary, Dept. Of Health Development of dengue virus vaccine components
JP2013542224A (ja) * 2010-10-29 2013-11-21 メルク・シャープ・アンド・ドーム・コーポレーション デングウイルス組換えサブユニットスワクチン
WO2014016362A1 (en) * 2012-07-24 2014-01-30 Sanofi Pasteur Vaccine compositions for prevention against dengue virus infection

Family Cites Families (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6184024B1 (en) 1988-07-14 2001-02-06 The United States Of America As Represented By The Department Of Health And Human Services Chimeric and/or growth-restricted flaviviruses
US6190859B1 (en) 1995-04-17 2001-02-20 The United States Of America As Represented By The Secretary Of The Army Method and kit for detection of dengue virus
US6254873B1 (en) 1995-04-17 2001-07-03 The United States Of America As Represented By The Secretary Of The Army Inactivated dengue virus vaccine
WO1996040933A1 (en) 1995-06-07 1996-12-19 The Government Of The United States Of America, Represented By The Secretary Department Of Health And Human Services Infectious dengue 2 virus pdk-53 as quadravalent vaccine
EP0836090A1 (en) 1996-10-12 1998-04-15 Evotec BioSystems GmbH Method of analysis of samples by determination of the distribution of specific brightnesses of particles
NZ337522A (en) 1997-02-28 2001-02-23 St Chimeric flavivirus incorporating yellow fever virus modified such that a prM-E protein of a second flavivirus is expressed, and vaccines for flavivruses
JP2001511459A (ja) 1997-07-31 2001-08-14 ハワイ バイオテクノロジー グループ， インコーポレイテッド フラビウイルス感染に対抗する組換え二量体エンベロープワクチン
CA2341354C (en) 1998-09-02 2009-10-20 The Government Of The United States Of America Dengue viruses that are replication defective in mosquitos for use as vaccines
EP1165128A2 (en) 1999-03-26 2002-01-02 Walter Reed Army Institute of Research Attenuated dengue-2 virus vaccine
ES2322327T3 (es) 1999-03-26 2009-06-19 Walter Reed Army Institute Of Research Vacuna multivalente contra el virus del dengue.
AU4179200A (en) 1999-03-26 2000-10-16 Walter Reed Army Institute Of Research Attenuated dengue-1 virus vaccine
WO2000057910A1 (en) 1999-03-26 2000-10-05 Walter Reed Army Institute Of Research Attenuated dengue-4 virus vaccine
US6432411B1 (en) 1999-07-13 2002-08-13 Hawaii Biotechnology Group Recombinant envelope vaccine against flavivirus infection
EP1402075B1 (en) 2001-05-22 2012-11-14 THE GOVERNMENT OF THE UNITED STATES OF AMERICA, as represented by THE SECRETARY, the Department of Health and Human Services, Development of mutations useful for attenuating dengue viruses and chimeric dengue viruses
AU2003267937C1 (en) 2002-01-15 2019-08-08 Sanofi Pasteur Biologics, Llc Flavivirus vaccines
DK2338508T3 (en) * 2002-05-03 2018-05-28 The Government Of The Us Secretary Department Of Health And Human Services rDEN3 / 4delta30 (ME), rDEN2 / 4delta30 (ME) or rDEN1 / 4delta30 (ME) recombinant chimeric Dengue virus containing a 30 nucleotide deletion (delta30) in a section of the 3 'untranslated region of Dengue type 4 genome, where The 30-nucleotide deletion corresponds to the TL2 hairpin structure
WO2003101397A2 (en) 2002-05-31 2003-12-11 Acambis, Inc. Tetravalent dengue vaccines
US7189403B2 (en) 2003-06-30 2007-03-13 Institut Pasteur Attenuated flavivirus strains containing a mutated M-ectodomain and their applications
EP1699814A4 (en) 2003-12-08 2009-01-14 Hybridon Inc MODULATION OF IMMUNOSTIMULATORY PROPERTIES OF COMPOUNDS FORMED FROM SMALL OLIGONUCLEOTIDES
US8029802B2 (en) 2004-10-20 2011-10-04 Sanofi Pasteur Biologics Co. Vaccines against Japanese encephalitis virus and West Nile virus
ATE475706T1 (de) 2005-06-17 2010-08-15 Sanofi Pasteur Abgeschwächter dengue-serotyp-2-stamm
CA2611934C (en) 2005-06-17 2015-11-03 Sanofi Pasteur Dengue serotype 1 attenuated strain
CN101222936A (zh) 2005-06-24 2008-07-16 英特威国际有限公司 灭活的嵌合疫苗和相关的使用方法
US8017754B2 (en) 2005-07-22 2011-09-13 Research Development Foundation Attenuated virus strains and uses thereof
US7470674B2 (en) 2005-11-07 2008-12-30 Idera Pharmaceuticals, Inc. Immunostimulatory properties of oligonucleotide-based compounds comprising modified immunostimulatory dinucleotides
AR061197A1 (es) 2006-06-07 2008-08-13 Sanofi Pasteur Cepas del virus 3 del dengue vivas atenuadas
FR2906724B1 (fr) 2006-10-04 2009-03-20 Sanofi Pasteur Sa Methode d'immunisation contre les 4 serotypes de la dengue.
WO2008127307A2 (en) 2006-11-09 2008-10-23 The United States Of America As Represented By The Secretary Of The Navy Induction of an immune response against dengue virus using prime-boost approach
US8440202B2 (en) 2006-11-09 2013-05-14 The United States Of America As Represented By The Secretary Of The Navy Induction of an immune response against dengue virus using the prime-boost approach
BRPI0904020B8 (pt) * 2009-10-01 2021-05-25 Fundacao Oswaldo Cruz composição vacinal contra o vírus da dengue, e, kit
WO2012065105A2 (en) * 2010-11-12 2012-05-18 Thomas Monath Chimeric flavivirus vaccines
JP2016523251A (ja) 2013-06-21 2016-08-08 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． デングウイルスワクチン組成物およびその使用方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100104598A1 (en) * 2006-08-15 2010-04-29 The Government Of The U.S.A., As Represented By The Secretary, Dept. Of Health Development of dengue virus vaccine components
JP2013542224A (ja) * 2010-10-29 2013-11-21 メルク・シャープ・アンド・ドーム・コーポレーション デングウイルス組換えサブユニットスワクチン
WO2014016362A1 (en) * 2012-07-24 2014-01-30 Sanofi Pasteur Vaccine compositions for prevention against dengue virus infection

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EP3236997A4 (en) 2018-05-30
ES2981476T3 (es) 2024-10-09
MY192543A (en) 2022-08-26
CL2017001595A1 (es) 2018-01-26
PH12017501165B1 (en) 2023-02-22
US10449243B2 (en) 2019-10-22
SG11201704942QA (en) 2017-07-28
MX2017008342A (es) 2017-10-24
NI201700080A (es) 2017-07-18
EP3236997A2 (en) 2017-11-01
CO2017005830A2 (es) 2017-08-31
EP3236997B1 (en) 2024-05-29
CR20170280A (es) 2017-08-21
MX383329B (es) 2025-03-13
AU2015369875A1 (en) 2017-06-15
US20170360917A1 (en) 2017-12-21
WO2016106107A2 (en) 2016-06-30
PH12017501165A1 (en) 2017-12-11
WO2016106107A3 (en) 2016-08-18
BR112017013270A2 (pt) 2018-03-06
CN106999568A (zh) 2017-08-01

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