MX2019001780A - Composicion de vacuna multivalente novedosa. - Google Patents

Composicion de vacuna multivalente novedosa.

Info

Publication number
MX2019001780A
MX2019001780A MX2019001780A MX2019001780A MX2019001780A MX 2019001780 A MX2019001780 A MX 2019001780A MX 2019001780 A MX2019001780 A MX 2019001780A MX 2019001780 A MX2019001780 A MX 2019001780A MX 2019001780 A MX2019001780 A MX 2019001780A
Authority
MX
Mexico
Prior art keywords
antigen
alum
ipv
antigens
rotavirus
Prior art date
Application number
MX2019001780A
Other languages
English (en)
Inventor
Shankar Pisal Sambhaji
Mhalasakant Dhere Rajeev
Kamalaji Zade Jagdish
Narayan SABALE Rajendra
Bapurao Kadam Ravindra
Sanjeev Kamble Abhijeet
Jiang Baoming
Glass Roger
Original Assignee
Serum Institute Of India Pvt Ltd
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 Serum Institute Of India Pvt Ltd filed Critical Serum Institute Of India Pvt Ltd
Publication of MX2019001780A publication Critical patent/MX2019001780A/es

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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
    • A61K39/295Polyvalent viral antigens; Mixtures of viral and bacterial antigens
    • 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
    • A61K39/02Bacterial antigens
    • A61K39/099Bordetella
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/125Picornaviridae, e.g. calicivirus
    • A61K39/13Poliovirus
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • 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
    • 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
    • A61K2039/5252Virus inactivated (killed)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55544Bacterial toxins
    • 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
    • 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
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/32011Picornaviridae
    • C12N2770/32611Poliovirus
    • C12N2770/32634Use 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Virology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Communicable Diseases (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invención se refiere a una vacuna o vacunas de combinación inmunogénica estables que comprenden una mezcla de antígenos para la prevención y profilaxis de infecciones causadas por el rotavirus, el virus de la poliomielitis, Haemophilus influenzae, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis y el virus de la Hepatitis B. La invención proporciona en particular una vacuna de combinación multivalente que comprende: i) antígenos de IPV Salk o IPV Sabin (IPV) en dosis significativamente reducida, preparados mediante el uso de métodos mejorados de inactivación de formaldehído y adsorción de hidróxido de aluminio, que dan como resultado la recuperación máxima del antígeno D y ii) Antígeno (s) de rotavirus inactivado por calor e inyectable obtenido de cepas de rotavirus (CDC-9) que proporcionan una amplia inmunidad de protección cruzada entre las cepas de rotavirus humano, iii) conjugado de PRP de Hib-proteína transportadora que tiene estabilidad e inmunogenicidad mejoradas en donde el conjugado de PRP Hib-proteína transportadora es inicialmente preparado usando un nuevo proceso de conjugación y posteriormente se mezcla a baja temperatura en presencia de un estabilizador para minimizar la liberación de PRP libre, iv) antígeno de pertussis de células completas con inmunogenicidad y estabilidad mejoradas obtenidas mediante la adición de antígeno de pertussis de células enteras en una etapa posterior en una mezcla, minimizando así la degradación basada en hidrólisis v) fracciones homogéneas de toxoide de difteria y toxoide tetánico obtenidos mediante la eliminación de agregados no deseados por el uso de cromatografía por permeación en gel. También se describe el proceso para producir estas composiciones de vacunas inmunogénicas estables mediante las etapas de i) adsorber individualmente IPV en dosis reducida, antígenos de IRV en el hidróxido de aluminio, manteniendo el otro antígeno (s) no absorbido o adsorbido en fosfato de aluminio, hidróxido de aluminio, en una combinación de hidróxido de aluminio y fosfato de aluminio y ii) usar un orden particular de adición de antígenos durante la mezcla.
MX2019001780A 2016-08-26 2017-08-24 Composicion de vacuna multivalente novedosa. MX2019001780A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201621029037 2016-08-26
PCT/IB2017/055100 WO2018037365A1 (en) 2016-08-26 2017-08-24 Multivalent vaccine composition

Publications (1)

Publication Number Publication Date
MX2019001780A true MX2019001780A (es) 2020-01-13

Family

ID=60083359

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019001780A MX2019001780A (es) 2016-08-26 2017-08-24 Composicion de vacuna multivalente novedosa.

Country Status (17)

Country Link
US (1) US11235054B2 (es)
EP (1) EP3503917B1 (es)
JP (3) JP7384667B2 (es)
KR (1) KR102607295B1 (es)
CN (1) CN110691611A (es)
AU (1) AU2017316768B2 (es)
BR (1) BR112019003419A2 (es)
CA (1) CA3032901A1 (es)
CU (1) CU24682B1 (es)
EA (1) EA201900117A1 (es)
IL (1) IL264605B2 (es)
MX (1) MX2019001780A (es)
MY (1) MY191163A (es)
PE (1) PE20200004A1 (es)
PH (1) PH12019500404A1 (es)
SG (1) SG11201900365WA (es)
WO (1) WO2018037365A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11201900365WA (en) * 2016-08-26 2019-02-27 Serum Institute Of India Pvt Ltd Multivalent vaccine composition
EP3621645A4 (en) * 2017-05-10 2021-01-27 University of Massachusetts BIVALENT DENGUE / HEPATITIS B VACCINES
JOP20190242A1 (ar) * 2018-10-12 2020-04-12 Serum Institute Of India Pvt Ltd تركيبة لقاح توليفي تشمل فيروس شلل الأطفال ذو جرعة مخفّضة خاملة التنشيط وطريقة لتحضيرها
JOP20200214A1 (ar) 2019-09-03 2021-03-03 Serum Institute Of India Pvt Ltd تركيبات مولدة للمناعة ضد الأمراض المعوية وطرق لتحضيرها

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006113528A2 (en) 2005-04-18 2006-10-26 Novartis Vaccines And Diagnostics Inc. Expressing hepatitis b virus surface antigen for vaccine preparation
MX2009002560A (es) * 2006-09-07 2009-03-20 Glaxosmithkline Biolog Sa Vacuna.
PE20100365A1 (es) * 2008-10-24 2010-05-21 Panacea Biotec Ltd Novedosas vacunas de combinacion con tos ferina de celulas enteras y metodo para su elaboracion
CA3121471A1 (en) 2009-05-12 2010-11-18 The Government Of The United States Of America, As Represented By The Secretary, Department Of Health And Human Services, Centers For Disease Control And Prevention New human rotavirus strains and vaccines
EP3459562B1 (en) * 2011-01-05 2024-03-20 Bharat Biotech International Limited A combination heptavalent vaccine
US20140112950A1 (en) * 2011-03-02 2014-04-24 Manmohan Singh Combination vaccines with lower doses of antigen and/or adjuvant
HUE049104T2 (hu) * 2014-10-07 2020-08-28 Serum Institute Of India Pvt Ltd Javított eljárások poliovírus inaktiválására, adjuváns adszorpciója
SG11201900365WA (en) * 2016-08-26 2019-02-27 Serum Institute Of India Pvt Ltd Multivalent vaccine composition

Also Published As

Publication number Publication date
KR102607295B1 (ko) 2023-11-29
EP3503917B1 (en) 2024-07-03
IL264605B2 (en) 2023-04-01
IL264605B (en) 2022-12-01
MY191163A (en) 2022-06-03
SG11201900365WA (en) 2019-02-27
WO2018037365A8 (en) 2018-09-20
KR20190142311A (ko) 2019-12-26
AU2017316768B2 (en) 2024-04-11
CA3032901A1 (en) 2018-03-01
US11235054B2 (en) 2022-02-01
EP3503917A1 (en) 2019-07-03
EA201900117A1 (ru) 2019-09-30
PH12019500404A1 (en) 2020-01-20
JP7384667B2 (ja) 2023-11-21
WO2018037365A1 (en) 2018-03-01
JP2024009899A (ja) 2024-01-23
JP2021181445A (ja) 2021-11-25
PE20200004A1 (es) 2020-01-06
CN110691611A (zh) 2020-01-14
AU2017316768A1 (en) 2019-04-11
US20190175722A1 (en) 2019-06-13
CU20190013A7 (es) 2019-10-04
IL264605A (en) 2019-02-28
CU24682B1 (es) 2023-10-06
JP2019526635A (ja) 2019-09-19
BR112019003419A2 (pt) 2019-05-21

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