JP7526880B2 - 6種混合液状ワクチン組成物 - Google Patents

6種混合液状ワクチン組成物 Download PDF

Info

Publication number
JP7526880B2
JP7526880B2 JP2023515483A JP2023515483A JP7526880B2 JP 7526880 B2 JP7526880 B2 JP 7526880B2 JP 2023515483 A JP2023515483 A JP 2023515483A JP 2023515483 A JP2023515483 A JP 2023515483A JP 7526880 B2 JP7526880 B2 JP 7526880B2
Authority
JP
Japan
Prior art keywords
adjuvant
hbs
aluminum
prp
added
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.)
Active
Application number
JP2023515483A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2022224966A5 (https=
JPWO2022224966A1 (https=
Inventor
駿 山下
達哉 白井
和広 大門
智博 簑田
慎二 赤▲崎▼
香奈衣 石川
春菜 岩田
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KM Biologics Co Ltd
Original Assignee
KM Biologics Co 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 KM Biologics Co Ltd filed Critical KM Biologics Co Ltd
Publication of JPWO2022224966A1 publication Critical patent/JPWO2022224966A1/ja
Publication of JPWO2022224966A5 publication Critical patent/JPWO2022224966A5/ja
Application granted granted Critical
Publication of JP7526880B2 publication Critical patent/JP7526880B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • 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
    • A61K39/0018Combination vaccines based on acellular diphtheria-tetanus-pertussis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/05Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/08Clostridium, e.g. Clostridium tetani
    • 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
    • A61K39/02Bacterial antigens
    • A61K39/102Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/116Polyvalent 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
    • 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
    • A61K39/145Orthomyxoviridae, e.g. influenza 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
    • A61K39/29Hepatitis virus
    • A61K39/292Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • A61P31/14Antivirals for RNA viruses
    • 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
    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
    • 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
    • A61P31/20Antivirals for DNA 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
    • A61K2039/5252Virus inactivated (killed)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal 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
    • 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
    • A61K2039/55516Proteins; Peptides
    • 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
    • C12N2730/00Reverse transcribing DNA viruses
    • C12N2730/00011Details
    • C12N2730/10011Hepadnaviridae
    • C12N2730/10111Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10134Use 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)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Communicable Diseases (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Biotechnology (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2023515483A 2021-04-20 2022-04-19 6種混合液状ワクチン組成物 Active JP7526880B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2021070897 2021-04-20
JP2021070897 2021-04-20
PCT/JP2022/018211 WO2022224966A1 (ja) 2021-04-20 2022-04-19 6種混合液状ワクチン組成物

Publications (3)

Publication Number Publication Date
JPWO2022224966A1 JPWO2022224966A1 (https=) 2022-10-27
JPWO2022224966A5 JPWO2022224966A5 (https=) 2024-01-10
JP7526880B2 true JP7526880B2 (ja) 2024-08-01

Family

ID=83722353

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023515483A Active JP7526880B2 (ja) 2021-04-20 2022-04-19 6種混合液状ワクチン組成物

Country Status (8)

Country Link
US (1) US12268738B2 (https=)
EP (1) EP4327820A4 (https=)
JP (1) JP7526880B2 (https=)
KR (1) KR102861088B1 (https=)
CN (1) CN117177768A (https=)
MY (1) MY208608A (https=)
TW (1) TWI880080B (https=)
WO (1) WO2022224966A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7526880B2 (ja) * 2021-04-20 2024-08-01 Kmバイオロジクス株式会社 6種混合液状ワクチン組成物

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015533148A (ja) 2012-10-12 2015-11-19 グラクソスミスクライン バイオロジカルズ ソシエテ アノニム 混合ワクチン用の架橋されていない無細胞百日咳抗原
JP2017203043A (ja) 2012-01-17 2017-11-16 サノフィ パスツール エスエー 水酸化酸化アルミニウムへ吸着可能な少なくとも2種類の抗原を含有するワクチンの調製方法
WO2018074296A1 (ja) 2016-10-20 2018-04-26 一般財団法人化学及血清療法研究所 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

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI945483A7 (fi) 1992-05-23 1995-01-20 Smithkline Beecham Biologicals S A Hepatiitti B - pinta-antigeenejä ja muita antigeenejä sisältäviä yhdistelmärokotteita
FR2734484B1 (fr) 1995-05-24 1997-06-27 Pasteur Merieux Serums Vacc Composition vaccinale liquide et procede de fabrication
CA2303105A1 (en) 1997-09-15 1999-03-25 Pasteur Merieux Msd Multivalent vaccines
JP6606600B2 (ja) * 2016-04-15 2019-11-13 富士フイルム株式会社 マイクロニードルアレイ
GEP20227386B (en) * 2017-07-18 2022-06-10 Serum Institute Of India Pvt Ltd Immunogenic composition having improved stability, enhanced immunogenicity and reduced reactogenicity and process for preparation thereof
JP7526880B2 (ja) * 2021-04-20 2024-08-01 Kmバイオロジクス株式会社 6種混合液状ワクチン組成物

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017203043A (ja) 2012-01-17 2017-11-16 サノフィ パスツール エスエー 水酸化酸化アルミニウムへ吸着可能な少なくとも2種類の抗原を含有するワクチンの調製方法
JP2015533148A (ja) 2012-10-12 2015-11-19 グラクソスミスクライン バイオロジカルズ ソシエテ アノニム 混合ワクチン用の架橋されていない無細胞百日咳抗原
WO2018074296A1 (ja) 2016-10-20 2018-04-26 一般財団法人化学及血清療法研究所 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

Also Published As

Publication number Publication date
US20240197863A1 (en) 2024-06-20
EP4327820A1 (en) 2024-02-28
WO2022224966A1 (ja) 2022-10-27
KR102861088B1 (ko) 2025-09-17
CN117177768A (zh) 2023-12-05
TW202308684A (zh) 2023-03-01
EP4327820A4 (en) 2025-09-17
TWI880080B (zh) 2025-04-11
MY208608A (en) 2025-05-20
US12268738B2 (en) 2025-04-08
JPWO2022224966A1 (https=) 2022-10-27
KR20230173114A (ko) 2023-12-26

Similar Documents

Publication Publication Date Title
EP2066344B2 (en) Inactivated Poliovirus combination vaccine
AU785433B2 (en) Combined vaccines comprising hepatitis B surface antigen and other antigens
TWI786153B (zh) 具有改善之安定性、增強之免疫原性及降低之反應原性的免疫原性組成物和其製備方法
US20110206726A1 (en) Combination vaccine with acellular pertussis
EP2682127A1 (en) Vaccine
JP4954056B2 (ja) 低用量のHib結合体との組合せワクチン
RU2613295C2 (ru) Комбинированная вакцина с цельноклеточным коклюшем
KR102822878B1 (ko) 감소된 용량의 불활성화된 폴리오바이러스를 포함하는 조합 백신 조성물 및 그의 제조 방법
JP2008533125A (ja) 全細胞百日咳抗原を含む混合ワクチン
JP7526880B2 (ja) 6種混合液状ワクチン組成物
KR102607295B1 (ko) 다가 백신 조성물
US8574589B2 (en) Antigen purification process for pertactin antigen
JP2008536515A (ja) ワクチンの調製のためのb型肝炎ウイルス表面抗原の発現
KR102388325B1 (ko) 저분자화 PRP를 사용한 Hib 컨쥬게이트 백신의 제조방법
EA043682B1 (ru) Комбинированная вакцина и способ её производства (варианты)

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20231219

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20231219

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20231219

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240206

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240401

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20240502

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: 20240702

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20240722

R150 Certificate of patent or registration of utility model

Ref document number: 7526880

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150