NZ731341B2 - Improved methods for enterovirus inactivation, adjuvant adsorption and dose reduced vaccine compositions obtained thereof - Google Patents
Improved methods for enterovirus inactivation, adjuvant adsorption and dose reduced vaccine compositions obtained thereof Download PDFInfo
- Publication number
- NZ731341B2 NZ731341B2 NZ731341A NZ73134115A NZ731341B2 NZ 731341 B2 NZ731341 B2 NZ 731341B2 NZ 731341 A NZ731341 A NZ 731341A NZ 73134115 A NZ73134115 A NZ 73134115A NZ 731341 B2 NZ731341 B2 NZ 731341B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- type
- neisseria meningitidis
- poliovirus particles
- poliovirus
- producing
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract 8
- 239000000203 mixture Substances 0.000 title claims abstract 6
- 239000002671 adjuvant Substances 0.000 title claims abstract 4
- 238000001179 sorption measurement Methods 0.000 title claims abstract 4
- 229960005486 vaccine Drugs 0.000 title claims 4
- 241000709661 Enterovirus Species 0.000 title 1
- 230000002779 inactivation Effects 0.000 title 1
- 239000007983 Tris buffer Substances 0.000 claims abstract 2
- 229910052782 aluminium Inorganic materials 0.000 claims abstract 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims abstract 2
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims abstract 2
- 229910021502 aluminium hydroxide Inorganic materials 0.000 claims abstract 2
- 239000000427 antigen Substances 0.000 claims abstract 2
- 241000991587 Enterovirus C Species 0.000 claims 10
- 239000002245 particle Substances 0.000 claims 8
- 241000588650 Neisseria meningitidis Species 0.000 claims 6
- 229940029583 inactivated polio vaccine Drugs 0.000 claims 4
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims 3
- 239000000872 buffer Substances 0.000 claims 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 241000274177 Juniperus sabina Species 0.000 claims 2
- 201000005702 Pertussis Diseases 0.000 claims 2
- 159000000013 aluminium salts Chemical class 0.000 claims 2
- 229910000329 aluminium sulfate Inorganic materials 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000008363 phosphate buffer Substances 0.000 claims 2
- JKMHFZQWWAIEOD-UHFFFAOYSA-N 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid Chemical compound OCC[NH+]1CCN(CCS([O-])(=O)=O)CC1 JKMHFZQWWAIEOD-UHFFFAOYSA-N 0.000 claims 1
- DVLFYONBTKHTER-UHFFFAOYSA-N 3-(N-morpholino)propanesulfonic acid Chemical compound OS(=O)(=O)CCCN1CCOCC1 DVLFYONBTKHTER-UHFFFAOYSA-N 0.000 claims 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- 239000007995 HEPES buffer Substances 0.000 claims 1
- 241000606768 Haemophilus influenzae Species 0.000 claims 1
- 239000007993 MOPS buffer Substances 0.000 claims 1
- 241000293871 Salmonella enterica subsp. enterica serovar Typhi Species 0.000 claims 1
- 241000193998 Streptococcus pneumoniae Species 0.000 claims 1
- 229940037003 alum Drugs 0.000 claims 1
- ILRRQNADMUWWFW-UHFFFAOYSA-K aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 claims 1
- 229940001007 aluminium phosphate Drugs 0.000 claims 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 229940001442 combination vaccine Drugs 0.000 claims 1
- 229960003983 diphtheria toxoid Drugs 0.000 claims 1
- 229940047650 haemophilus influenzae Drugs 0.000 claims 1
- 208000005252 hepatitis A Diseases 0.000 claims 1
- 208000002672 hepatitis B Diseases 0.000 claims 1
- 230000000415 inactivating effect Effects 0.000 claims 1
- 238000011534 incubation Methods 0.000 claims 1
- 244000052769 pathogen Species 0.000 claims 1
- 230000001717 pathogenic effect Effects 0.000 claims 1
- 229940031000 streptococcus pneumoniae Drugs 0.000 claims 1
- 229960000814 tetanus toxoid Drugs 0.000 claims 1
- 125000002306 tributylsilyl group Chemical group C(CCC)[Si](CCCC)(CCCC)* 0.000 claims 1
- 239000003656 tris buffered saline Substances 0.000 claims 1
- 229940124867 Poliovirus vaccine Drugs 0.000 abstract 1
- 239000004411 aluminium Substances 0.000 abstract 1
- 239000002609 medium Substances 0.000 abstract 1
- 238000011084 recovery Methods 0.000 abstract 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 abstract 1
Classifications
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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
- 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
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
- A61K2039/5254—Virus avirulent or attenuated
-
- 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
- A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
- A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
-
- 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
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
-
- 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
- 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
- C12N2770/32311—Enterovirus
- C12N2770/32334—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
-
- 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
-
- 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
- C12N2770/32661—Methods of inactivation or attenuation
- C12N2770/32663—Methods of inactivation or attenuation by chemical treatment
-
- 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
- C12N2770/32671—Demonstrated in vivo effect
-
- 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
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
-
- 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
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
- C12N7/04—Inactivation or attenuation; Producing viral sub-units
- C12N7/045—Pseudoviral particles; Non infectious pseudovirions, e.g. genetically engineered
-
- 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
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
- C12N7/04—Inactivation or attenuation; Producing viral sub-units
- C12N7/06—Inactivation or attenuation by chemical treatment
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- 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
Abstract
The present invention is directed to an improved method of producing poliovirus vaccine, using a M-199 medium, TRIS buffer and Aluminium adjuvant at specific concentrations and pH to maximise recovery of D-antigen. Subsequent adsorption of said sIPV on aluminium hydroxide provides significantly dose reduced sIPV compositions.
Claims (7)
1. A method for producing a vaccine composition comprising inactivated poliovirus particles, the method comprising the steps of: a) producing a medium containing the poliovirus particles; b) purifying the poliovirus particles from the medium in the presence of a phosphate buffer; c) exchanging the phosphate buffer of the poliovirus particles with a buffer selected from TRIS, TBS, MOPS, HEPES, and bicarbonate buffers having a pH of 6.8 to 7.2 and a concentration in the range of 30 mM to 50 mM; d) adding 10X concentrated M-199 medium containing 0.5 % glycine to achieve final concentration of 1x e) inactivating the poliovirus particles by incubation with 0.025 % formaldehyde at 37 °C for 5 to 13 days; and, f) adsorption of poliovirus particles on Aluminium salt adjuvant whereby percentage adsorption on alum is at least 95% and wherein aluminum content per 0.5mL dose, is 0.4 mg Al3+ for Type 1, 0.2mg Al3+ for Type 2, and 0.2mg Al3+ for Type 3.
2. The method as claimed in claim 1, wherein the buffer has a concentration of 40 mM.
3. The method as claimed in claim 1, wherein the aluminium salt adjuvant of step (e) is selected from a group of aluminium hydroxide, or aluminium phosphate, or a mixture of both.
4. The method as claimed in claim 1, wherein the poliovirus particles comprise polioviruses of the Sabin serotypes 1, 2 and 3.
5. The method as claimed in claim 1, wherein the poliovirus particles comprise polioviruses of Salk serotypes IPV Type 1, IPV Type 2; and/or IPV Type 3.
6. The method as claimed in claims 1 to 5, wherein said vaccine composition is a Combination Vaccine containing Sabin Inactivated Polio Vaccine which comprises of one or 21544897 512122NZPR more antigens from a pathogen selected from a list consisting of: Haemophilus influenzae b, Neisseria meningitidis type A, Neisseria Meningitidis type C, Neisseria meningitidis type W- 135, Neisseria meningitidis type Y, Neisseria meningitidis type X, Neisseria meningitidis type B, Streptococcus pneumoniae, Salmonella typhi, Hepatitis A, Hepatitis B, diphtheria toxoid, tetanus toxoid, whole cell pertussis, acellular pertussis.
7. A method for producing a vaccine composition according to claim 1, substantially as herein described with reference to any example thereof and with or without reference to any one or more of the accompanying figures. SHEET
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN3180MU2014 | 2014-10-07 | ||
| PCT/IN2015/000376 WO2016063291A1 (en) | 2014-10-07 | 2015-10-06 | Improved methods for enterovirus inactivation, adjuvant adsorption and dose reduced vaccine compositions obtained thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ731341A NZ731341A (en) | 2023-11-24 |
| NZ731341B2 true NZ731341B2 (en) | 2024-02-27 |
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