ES2528665T3 - Fabricación de vacunas amplificadoras que tienen dosis de antígeno reducidas - Google Patents

Fabricación de vacunas amplificadoras que tienen dosis de antígeno reducidas Download PDF

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Publication number
ES2528665T3
ES2528665T3 ES07825522.1T ES07825522T ES2528665T3 ES 2528665 T3 ES2528665 T3 ES 2528665T3 ES 07825522 T ES07825522 T ES 07825522T ES 2528665 T3 ES2528665 T3 ES 2528665T3
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Prior art keywords
vaccines
amplifying
manufacture
reduced antigen
antigen doses
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ES07825522.1T
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English (en)
Inventor
Koenraad De Heyder
Claude Artois
Christian Vandecasserie
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GlaxoSmithKline Biologicals SA
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GlaxoSmithKline Biologicals SA
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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
    • 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
    • A61K39/0016—Combination vaccines based on diphtheria-tetanus-pertussis
    • A61K39/0018—Combination vaccines based on acellular diphtheria-tetanus-pertussis
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/05—Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/099—Bordetella
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/125—Picornaviridae, e.g. calicivirus
    • A61K39/13—Poliovirus
    • 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
    • A61P31/04—Antibacterial agents
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • 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
    • A61K2039/545—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
    • A61K2039/70—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
    • C12N2770/32011—Picornaviridae
    • C12N2770/32611—Poliovirus
    • C12N2770/32622—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
    • C12N2770/32011—Picornaviridae
    • C12N2770/32611—Poliovirus
    • C12N2770/32634—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Virology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Un procedimiento de fabricación de una vacuna, en el que la vacuna comprende toxoide diftérico y toxoide tetánico, y en el que el procedimiento comprende las etapas de combinar (i) un primer volumen que comprende toxoide diftérico y toxoide tetánico a una relación de difteria: tétanos entre 2 : 1 y 3 : 1 (medida en unidades Lf) con (ii) un segundo volumen que comprende toxoide tetánico pero no toxoide diftérico.

Description

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Claims (1)

  1. imagen1
ES07825522.1T 2006-08-16 2007-08-15 Fabricación de vacunas amplificadoras que tienen dosis de antígeno reducidas Active ES2528665T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB0616306.7A GB0616306D0 (en) 2006-08-16 2006-08-16 Vaccines
GB0616306 2006-08-16
PCT/IB2007/003255 WO2008020328A2 (en) 2006-08-16 2007-08-15 Manufacture of booster vaccines having reduced antigen doses

Publications (1)

Publication Number Publication Date
ES2528665T3 true ES2528665T3 (es) 2015-02-11

Family

ID=37081096

Family Applications (1)

Application Number Title Priority Date Filing Date
ES07825522.1T Active ES2528665T3 (es) 2006-08-16 2007-08-15 Fabricación de vacunas amplificadoras que tienen dosis de antígeno reducidas

Country Status (7)

Country Link
US (1) US20100158940A1 (es)
EP (1) EP2073841B1 (es)
JP (2) JP5090452B2 (es)
CN (1) CN101522217B (es)
ES (1) ES2528665T3 (es)
GB (1) GB0616306D0 (es)
WO (1) WO2008020328A2 (es)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0822633D0 (en) * 2008-12-11 2009-01-21 Novartis Ag Formulation
US9950062B2 (en) 2009-09-02 2018-04-24 Glaxosmithkline Biologicals Sa Compounds and compositions as TLR activity modulators
BR112013005134A2 (pt) 2010-09-01 2018-04-24 Novartis Ag adsorção de imunopotenciadores em sais metálicos insolúveis
US20140112950A1 (en) 2011-03-02 2014-04-24 Manmohan Singh Combination vaccines with lower doses of antigen and/or adjuvant
CN102526717A (zh) * 2011-11-25 2012-07-04 成都康华生物制品有限公司 一种吸附无细胞百白破联合疫苗的制备方法
US20150125486A1 (en) * 2012-03-08 2015-05-07 Novartis Ag Adjuvanted formulations of pediatric antigens
CN104159602B (zh) * 2012-03-08 2017-10-24 葛兰素史密丝克莱恩生物有限公司 加强疫苗的含佐剂制剂
CN103908667A (zh) * 2014-04-18 2014-07-09 中国医学科学院医学生物学研究所 吸附无细胞百白破-Sabin株脊髓灰质炎联合疫苗及制备方法
CN104707134A (zh) * 2015-03-27 2015-06-17 成都欧林生物科技股份有限公司 一种无细胞百日破联合疫苗及其制备方法
EP3530285B1 (en) * 2016-10-20 2023-08-09 KM Biologics Co., Ltd. METHOD FOR PRODUCING HIB CONJUGATE VACCINE USING PRP WITH
LOWERED MOLECULAR WEIGHT
KR102426041B1 (ko) * 2017-08-01 2022-07-29 주식회사 녹십자 냉동 및 해동 과정을 포함하는 백일해균 유래 단백질 수득 방법
WO2020165920A1 (en) * 2019-02-12 2020-08-20 Biological E Limited Multivalent vaccine composition
CN111053898B (zh) * 2019-12-26 2023-05-16 北京科兴中维生物技术有限公司 一种疫苗组合物及其应用
CN114748616A (zh) * 2022-05-23 2022-07-15 中国医学科学院医学生物学研究所 一种成人青少年用无细胞百白破联合疫苗及其制备方法

Family Cites Families (9)

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Publication number Priority date Publication date Assignee Title
US5554125A (en) * 1987-07-08 1996-09-10 Reynolds; David L. Prefilled vial syringe
HU220236B (hu) * 1992-05-23 2001-11-28 Smithkline Beecham Biologicals S.A. Hepatitis B felszíni antigént és egyéb antigéneket tartalmazó, kombinált oltóanyagok
US6696065B1 (en) * 1995-05-04 2004-02-24 Aventis Pastuer Limited Acellular pertussis vaccines and methods of preparation thereof
JP3280675B2 (ja) * 1996-07-02 2002-05-13 コノート ラボラトリーズ リミテッド 多価ｄｔｐポリオワクチン
GB9623233D0 (en) * 1996-11-07 1997-01-08 Smithkline Beecham Biolog Vaccine composition
US20010014331A1 (en) * 1996-11-07 2001-08-16 Smithkline Beecham Biologicals S.A. Acellular pertussis vaccine with diphthriae-and tetanus-toxoids
ATE316797T1 (de) * 1997-09-15 2006-02-15 Sanofi Pasteur Msd Verfahren zur herstellung multivalenter impfstoffe
EP1004314A1 (fr) * 1998-11-26 2000-05-31 Pasteur Merieux MSD Vaccin T.d. Polio rappel pour une population vaccinée ou sensibilisée
KR100401423B1 (ko) * 2001-01-10 2003-10-17 주식회사 엘지생명과학 혼합 백신의 제조 방법

Also Published As

Publication number Publication date
CN101522217B (zh) 2014-07-16
EP2073841B1 (en) 2014-11-26
US20100158940A1 (en) 2010-06-24
JP2010500398A (ja) 2010-01-07
WO2008020328A2 (en) 2008-02-21
WO2008020328A3 (en) 2008-06-19
GB0616306D0 (en) 2006-09-27
EP2073841A2 (en) 2009-07-01
JP2012236864A (ja) 2012-12-06
CN101522217A (zh) 2009-09-02
JP5090452B2 (ja) 2012-12-05

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