JP5090452B2 - 低減された抗原用量を有するブースターワクチンの製造 - Google Patents

低減された抗原用量を有するブースターワクチンの製造 Download PDF

Info

Publication number
JP5090452B2
JP5090452B2 JP2009524255A JP2009524255A JP5090452B2 JP 5090452 B2 JP5090452 B2 JP 5090452B2 JP 2009524255 A JP2009524255 A JP 2009524255A JP 2009524255 A JP2009524255 A JP 2009524255A JP 5090452 B2 JP5090452 B2 JP 5090452B2
Authority
JP
Japan
Prior art keywords
vaccine
bulk
toxoid
diphtheria
tetanus
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
JP2009524255A
Other languages
English (en)
Japanese (ja)
Other versions
JP2010500398A (ja
JP2010500398A5 (enExample
Inventor
エリック フリングス，
クリストフ ハンガラー，
Original Assignee
ノバルティス アーゲー
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 ノバルティス アーゲー filed Critical ノバルティス アーゲー
Publication of JP2010500398A publication Critical patent/JP2010500398A/ja
Publication of JP2010500398A5 publication Critical patent/JP2010500398A5/ja
Application granted granted Critical
Publication of JP5090452B2 publication Critical patent/JP5090452B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Virology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (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)
JP2009524255A 2006-08-16 2007-08-15 低減された抗原用量を有するブースターワクチンの製造 Expired - Fee Related JP5090452B2 (ja)

Applications Claiming Priority (3)

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2012200460A Division JP2012236864A (ja) 2006-08-16 2012-09-12 低減された抗原用量を有するブースターワクチンの製造

Publications (3)

Publication Number Publication Date
JP2010500398A JP2010500398A (ja) 2010-01-07
JP2010500398A5 JP2010500398A5 (enExample) 2011-09-01
JP5090452B2 true JP5090452B2 (ja) 2012-12-05

Family

ID=37081096

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2009524255A Expired - Fee Related JP5090452B2 (ja) 2006-08-16 2007-08-15 低減された抗原用量を有するブースターワクチンの製造
JP2012200460A Pending JP2012236864A (ja) 2006-08-16 2012-09-12 低減された抗原用量を有するブースターワクチンの製造

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2012200460A Pending JP2012236864A (ja) 2006-08-16 2012-09-12 低減された抗原用量を有するブースターワクチンの製造

Country Status (7)

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

Families Citing this family (17)

* 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
ES2443952T3 (es) 2009-09-02 2014-02-21 Novartis Ag Composiciones inmunógenas que incluyen moduladores de la actividad de TLR
CN105999275A (zh) 2010-09-01 2016-10-12 诺华有限公司 免疫增强剂吸附不溶性金属离子
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
US9375471B2 (en) * 2012-03-08 2016-06-28 Glaxosmithkline Biologicals Sa Adjuvanted formulations of booster vaccines
US20150125486A1 (en) * 2012-03-08 2015-05-07 Novartis Ag Adjuvanted formulations of pediatric antigens
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
JP6944946B2 (ja) * 2016-10-20 2021-10-06 Ｋｍバイオロジクス株式会社 低分子化ＰＲＰを用いたＨｉｂコンジュゲートワクチンの製造方法
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
JP7704740B2 (ja) 2019-09-16 2025-07-08 アムジエン・インコーポレーテツド 薬物送達デバイスの外部滅菌の方法
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
CN119548620B (zh) * 2025-01-23 2025-09-12 康希诺生物股份公司 一种用于预防白喉、百日咳和破伤风的免疫原性组合物、疫苗及其制备方法和应用
CN119524117B (zh) * 2025-01-23 2025-09-23 康希诺生物股份公司 免疫原性组合物、百白破联合疫苗及其制备方法和应用

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5554125A (en) * 1987-07-08 1996-09-10 Reynolds; David L. Prefilled vial syringe
EP2156845A1 (en) * 1992-05-23 2010-02-24 GlaxoSmithKline Biologicals SA Combined vaccines comprising hepatitis B surface antigen and other antigens
US6696065B1 (en) * 1995-05-04 2004-02-24 Aventis Pastuer Limited Acellular pertussis vaccines and methods of preparation thereof
TR199802783T2 (xx) * 1996-07-02 1999-03-22 Connaught Laboratories Limited �ok de�erli DTP polyo a��lar.
US20010014331A1 (en) * 1996-11-07 2001-08-16 Smithkline Beecham Biologicals S.A. Acellular pertussis vaccine with diphthriae-and tetanus-toxoids
GB9623233D0 (en) * 1996-11-07 1997-01-08 Smithkline Beecham Biolog Vaccine composition
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
WO2008020328A3 (en) 2008-06-19
CN101522217A (zh) 2009-09-02
JP2010500398A (ja) 2010-01-07
EP2073841B1 (en) 2014-11-26
CN101522217B (zh) 2014-07-16
EP2073841A2 (en) 2009-07-01
US20100158940A1 (en) 2010-06-24
ES2528665T3 (es) 2015-02-11
GB0616306D0 (en) 2006-09-27
WO2008020328A2 (en) 2008-02-21
JP2012236864A (ja) 2012-12-06

Similar Documents

Publication Publication Date Title
JP5090452B2 (ja) 低減された抗原用量を有するブースターワクチンの製造
CA2621023C (en) Multiple vaccination including serogroup c meningococcus
CN101330927B (zh) 同时含乙肝病毒表面抗原和表面活性剂的疫苗的制造
US20100226937A1 (en) Combination vaccines with 1-hydroxy-2-phenoxyethane preservative
US9040058B2 (en) Fermentation media free of animal-derived components for production of diphtheria toxoids suitable for human vaccine use
EP2592137A1 (en) Fermentation media free of animal-derived components for production of diphtheria toxoids suitable for human vaccine use
AU2012261764B2 (en) Multiple vaccination including serogroup C meningococcus
AU2012261763B2 (en) Multiple vaccination including serogroup C meningococcus
GB2498112A (en) Preparation of a diphtheria toxoid by incubating toxin concentrate with an amino acid and formaldehyde

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20100721

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20100730

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20110214

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20110214

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20110706

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20120831

A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20120912

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20150921

Year of fee payment: 3

R150 Certificate of patent or registration of utility model

Free format text: JAPANESE INTERMEDIATE CODE: R150

S111 Request for change of ownership or part of ownership

Free format text: JAPANESE INTERMEDIATE CODE: R313113

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

RD02 Notification of acceptance of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: R3D02

LAPS Cancellation because of no payment of annual fees