MX2018007413A - Formulaciones de vacuna contra rotavirus termicamente estable y metodos de uso de la misma. - Google Patents

Formulaciones de vacuna contra rotavirus termicamente estable y metodos de uso de la misma.

Info

Publication number
MX2018007413A
MX2018007413A MX2018007413A MX2018007413A MX2018007413A MX 2018007413 A MX2018007413 A MX 2018007413A MX 2018007413 A MX2018007413 A MX 2018007413A MX 2018007413 A MX2018007413 A MX 2018007413A MX 2018007413 A MX2018007413 A MX 2018007413A
Authority
MX
Mexico
Prior art keywords
rotavirus
methods
thermally stable
vaccine formulations
rotavirus vaccine
Prior art date
Application number
MX2018007413A
Other languages
English (en)
Inventor
K Evans Robert
L Strable Erica
ISOPI Lynne
Original Assignee
Merck Sharp & Dohme
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Publication of MX2018007413A publication Critical patent/MX2018007413A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/15Reoviridae, e.g. calf diarrhea virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/0016Combination vaccines based on diphtheria-tetanus-pertussis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525Virus
    • A61K2039/5254Virus avirulent or attenuated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541Mucosal route
    • A61K2039/542Mucosal route oral/gastrointestinal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2720/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsRNA viruses
    • C12N2720/00011Details
    • C12N2720/12011Reoviridae
    • C12N2720/12311Rotavirus, e.g. rotavirus A
    • C12N2720/12334Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

La presente invención se relaciona a formulaciones de vacuna contra rotavirus orales térmicamente estables que comprenden uno o más reclasificadores de rotavirus o cepas atenuadas de rotavirus, una sal de calcio farmacéuticamente aceptable, ácido adípico, sacarosa, y fosfato de sodio, en donde cada uno del uno o más reclasificadores de rotavirus o cepas atenuadas de rotavirus está estable por 7 días a 37°C, por 45 días a 25°C y por 2 años o más a 2-8°C. Las formulaciones que contienen calcio de la invención pueden además comprender uno o más excipientes que están presentes en una cantidad que es efectiva para optimizar los iones de calcio libres en solución para estabilizar las partículas del rotavirus. En modalidades de la invención, la formulación comprende un tensoactivo, tal como polisorbato 80. La invención también se relaciona métodos de uso de las composiciones de vacuna contra rotavirus de la invención para prevenir la infección por rotavirus, o reducir la probabilidad de infección o para prevenir, aliviar, o retrasar la aparición o progreso de las manifestaciones clínicas de la misma.
MX2018007413A 2015-12-18 2016-12-13 Formulaciones de vacuna contra rotavirus termicamente estable y metodos de uso de la misma. MX2018007413A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562269419P 2015-12-18 2015-12-18
PCT/US2016/066248 WO2017106115A1 (en) 2015-12-18 2016-12-13 Thermally stable rotavirus vaccine formulations and methods of use thereof

Publications (1)

Publication Number Publication Date
MX2018007413A true MX2018007413A (es) 2018-08-15

Family

ID=59057455

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2018007413A MX2018007413A (es) 2015-12-18 2016-12-13 Formulaciones de vacuna contra rotavirus termicamente estable y metodos de uso de la misma.

Country Status (11)

Country Link
US (1) US10874732B2 (es)
EP (1) EP3389786A4 (es)
JP (1) JP2019502685A (es)
KR (1) KR20180095817A (es)
CN (1) CN108367164A (es)
AU (1) AU2016370401A1 (es)
BR (1) BR112018012181A2 (es)
CA (1) CA3006069A1 (es)
MX (1) MX2018007413A (es)
RU (1) RU2018126322A (es)
WO (1) WO2017106115A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113994925B (zh) * 2021-12-30 2022-04-26 北京赛尔富森生物科技有限公司 一种轮状病毒攻毒动物模型及其建立方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK0939648T3 (da) 1996-09-26 2008-02-11 Merck & Co Inc Rotavirusvaccineformuleringer
US6616931B1 (en) * 1996-09-26 2003-09-09 Merck & Co., Inc. Rotavirus vaccine formulations
US5932223A (en) 1996-09-26 1999-08-03 Merck & Co., Inc. Rotavirus vaccine formulations
US6656719B1 (en) 1997-10-27 2003-12-02 Merck & Co., Inc. Serum-free, low-protein media for rotavirus vaccine production
WO2001012797A2 (en) * 1999-08-17 2001-02-22 Smithkline Beecham Biologicals S.A. Method of separating rotavirus variants and live attenuated rotavirus vaccine
GB9919468D0 (en) * 1999-08-17 1999-10-20 Smithkline Beecham Biolog Vaccine
GB0503337D0 (en) * 2005-02-17 2005-03-23 Glaxosmithkline Biolog Sa Compositions
WO2009042202A2 (en) 2007-09-25 2009-04-02 Aridis Pharmaceuticals Formulations for preservation of rota virus
WO2013029033A2 (en) * 2011-08-25 2013-02-28 Brian Pulliam Rotavirus preparations with excess calcium ions and high viscosities that ensure vaccine viability at elevated temperatures
US10568957B2 (en) * 2012-04-23 2020-02-25 Bharat Biotech International Ltd. Rotavirus vaccine compositions and process for preparing the same
GB201614799D0 (en) * 2016-09-01 2016-10-19 Glaxosmithkline Biologicals Sa Compositions

Also Published As

Publication number Publication date
RU2018126322A (ru) 2020-01-20
BR112018012181A2 (pt) 2018-11-27
CA3006069A1 (en) 2017-06-22
US20190000957A1 (en) 2019-01-03
EP3389786A1 (en) 2018-10-24
KR20180095817A (ko) 2018-08-28
WO2017106115A1 (en) 2017-06-22
JP2019502685A (ja) 2019-01-31
CN108367164A (zh) 2018-08-03
AU2016370401A1 (en) 2018-05-31
EP3389786A4 (en) 2019-08-21
US10874732B2 (en) 2020-12-29

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