Title:
LIQUID SEXTUPLE VACCINE COMPOSITION
Document Type and Number:
WIPO Patent Application WO/2022/224966
Kind Code:
A1
Abstract:
The present invention provides a liquefied formulation of a sextuple vaccine which comprises DPT-IPV-Hib-HBs and in which an HBs antigen is stably adsorbed and held on an aluminum adjuvant and PRP that is an Hib antigen is stably bound to and held on a carrier protein. Provided is a method for producing a stable liquefied formulation of a sextuple vaccine against diphtheria, pertussis, tetanus, poliomyelitis, Haemophilus influenzae type b (Hib), and hepatitis B (HepB), said method comprising: (1) a step for mixing diphtheria toxoid (D) and tetanus toxoid (T) with an aluminum adjuvant to generate a DT adjuvant; (2) a step for mixing the DT adjuvant obtained in step (1) with a hepatitis B surface (HBs) antigen to generate a DT-HBs adjuvant; (3) a step for mixing the DT-HBs adjuvant obtained in step (2) with a pertussis antigen (P) to generate a DPT-HBs adjuvant; (4) a step for mixing the DPT-HBs adjuvant obtained in step (3) with an inactivated poliomyelitis virus (IPV) to generate a DPT-IPV-HBs adjuvant; (5) a step for adding a succinic acid-phosphoric acid buffer solution to the DPT-IPV-HBs adjuvant obtained in step (4), and then adding PRP (PRP-T conjugate) as an Hib antigen to generate a mixture of the PRP-T conjugate and the DPT-IPV-HBs adjuvant; and (6) a step for preparing pH of the mixture of the PRP-T conjugate and the DPT-IPV-HBs adjuvant obtained in step (5) to be 5.4-5.9.
Inventors:
YAMASHITA SHUN (JP)
SHIRAI TATSUYA (JP)
DAIMON KAZUHIRO (JP)
MINODA TOMOHIRO (JP)
AKASAKI SHINJI (JP)
ISHIKAWA KANAE (JP)
IWATA HARUNA (JP)
SHIRAI TATSUYA (JP)
DAIMON KAZUHIRO (JP)
MINODA TOMOHIRO (JP)
AKASAKI SHINJI (JP)
ISHIKAWA KANAE (JP)
IWATA HARUNA (JP)
Application Number:
PCT/JP2022/018211
Publication Date:
October 27, 2022
Filing Date:
April 19, 2022
Export Citation:
Assignee:
KM BIOLOGICS CO LTD (JP)
International Classes:
A61K39/116; A61K9/08; A61K39/05; A61K39/08; A61K39/10; A61K39/102; A61K39/13; A61K39/29; A61K39/295; A61K39/39; A61P31/04; A61P31/14; A61P31/16; A61P31/20
Domestic Patent References:
| WO2018074296A1 | 2018-04-26 | |||
| WO2018074296A1 | 2018-04-26 | |||
| WO1999013906A1 | 1999-03-25 | |||
| WO1996037222A1 | 1996-11-28 |
Foreign References:
| JP2017203043A | 2017-11-16 | |||
| JP2015533148A | 2015-11-19 | |||
| JPH07508267A | 1995-09-14 | |||
| JP2017203043A | 2017-11-16 |
Other References:
VACCINE, vol. 12, no. 8, 1994, pages 700 - 706
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, vol. 21, no. 6, 2000, pages 1087 - 1091
JOURNAL OF MICROBIOLOGY AND BIOTECHNOLOGY, vol. 13, no. 3, 2003, pages 469 - 472
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, vol. 21, no. 6, 2000, pages 1087 - 1091
JOURNAL OF MICROBIOLOGY AND BIOTECHNOLOGY, vol. 13, no. 3, 2003, pages 469 - 472
Attorney, Agent or Firm:
YAMAO, Norihito et al. (JP)
Download PDF:
Previous Patent: SPECIMEN RETENTION CARD AND SPECIMEN INSPECTION METHOD USING SAME
Next Patent: SADDLE-RIDE TYPE VEHICLE
Next Patent: SADDLE-RIDE TYPE VEHICLE