JP2018526437A - ノロウイルスワクチン - Google Patents
ノロウイルスワクチン Download PDFInfo
- Publication number
- JP2018526437A JP2018526437A JP2018529513A JP2018529513A JP2018526437A JP 2018526437 A JP2018526437 A JP 2018526437A JP 2018529513 A JP2018529513 A JP 2018529513A JP 2018529513 A JP2018529513 A JP 2018529513A JP 2018526437 A JP2018526437 A JP 2018526437A
- Authority
- JP
- Japan
- Prior art keywords
- norovirus
- composition
- vlp
- gii
- vaccine
- 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.)
- Granted
Links
- 241001263478 Norovirus Species 0.000 title claims abstract description 207
- 229960005486 vaccine Drugs 0.000 title claims abstract description 139
- 239000000203 mixture Substances 0.000 claims abstract description 137
- 239000000843 powder Substances 0.000 claims abstract description 128
- 239000000427 antigen Substances 0.000 claims abstract description 88
- 102000036639 antigens Human genes 0.000 claims abstract description 88
- 108091007433 antigens Proteins 0.000 claims abstract description 88
- 238000004519 manufacturing process Methods 0.000 claims abstract description 20
- 239000002245 particle Substances 0.000 claims abstract description 20
- 208000006339 Caliciviridae Infections Diseases 0.000 claims abstract description 19
- 229920001586 anionic polysaccharide Polymers 0.000 claims abstract description 13
- 150000004836 anionic polysaccharides Chemical class 0.000 claims abstract description 13
- 230000036039 immunity Effects 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims description 36
- 230000028993 immune response Effects 0.000 claims description 14
- 210000004027 cell Anatomy 0.000 claims description 10
- 239000000243 solution Substances 0.000 claims description 8
- 238000001035 drying Methods 0.000 claims description 7
- 238000004108 freeze drying Methods 0.000 claims description 6
- 241000701447 unidentified baculovirus Species 0.000 claims description 6
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical group C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 5
- 241000723873 Tobacco mosaic virus Species 0.000 claims description 5
- 239000007864 aqueous solution Substances 0.000 claims description 5
- 239000011734 sodium Substances 0.000 claims description 5
- 229910052708 sodium Inorganic materials 0.000 claims description 5
- 241000238631 Hexapoda Species 0.000 claims description 4
- 238000001694 spray drying Methods 0.000 claims description 4
- 241000588724 Escherichia coli Species 0.000 claims description 3
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims description 3
- 210000004962 mammalian cell Anatomy 0.000 claims description 3
- 229920001282 polysaccharide Polymers 0.000 claims description 3
- 239000005017 polysaccharide Substances 0.000 claims description 3
- 150000004804 polysaccharides Chemical class 0.000 claims description 3
- 210000001236 prokaryotic cell Anatomy 0.000 claims description 2
- 210000003527 eukaryotic cell Anatomy 0.000 claims 1
- 230000000977 initiatory effect Effects 0.000 claims 1
- 230000008685 targeting Effects 0.000 abstract 1
- 210000002966 serum Anatomy 0.000 description 63
- 230000003053 immunization Effects 0.000 description 55
- 238000002649 immunization Methods 0.000 description 54
- 230000003472 neutralizing effect Effects 0.000 description 29
- 229940031416 bivalent vaccine Drugs 0.000 description 23
- 238000011597 hartley guinea pig Methods 0.000 description 16
- 241000700198 Cavia Species 0.000 description 14
- 229940068196 placebo Drugs 0.000 description 14
- 239000000902 placebo Substances 0.000 description 14
- 230000000694 effects Effects 0.000 description 13
- 230000004044 response Effects 0.000 description 13
- 238000007918 intramuscular administration Methods 0.000 description 12
- 238000002965 ELISA Methods 0.000 description 11
- 230000005875 antibody response Effects 0.000 description 11
- 231100000673 dose–response relationship Toxicity 0.000 description 11
- 239000000546 pharmaceutical excipient Substances 0.000 description 9
- 230000005847 immunogenicity Effects 0.000 description 8
- 238000002844 melting Methods 0.000 description 8
- 230000008018 melting Effects 0.000 description 8
- 230000000903 blocking effect Effects 0.000 description 7
- 239000000872 buffer Substances 0.000 description 7
- 230000002163 immunogen Effects 0.000 description 7
- 208000024891 symptom Diseases 0.000 description 7
- 230000009885 systemic effect Effects 0.000 description 7
- 241000282412 Homo Species 0.000 description 6
- 241000532183 Norovirus GI Species 0.000 description 6
- 239000011534 wash buffer Substances 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 241000532184 Norovirus GII Species 0.000 description 5
- 230000000875 corresponding effect Effects 0.000 description 5
- 239000007927 intramuscular injection Substances 0.000 description 5
- 229940031346 monovalent vaccine Drugs 0.000 description 5
- 229940052404 nasal powder Drugs 0.000 description 5
- 229920000642 polymer Polymers 0.000 description 5
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 5
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 5
- 238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 5
- 238000001262 western blot Methods 0.000 description 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 4
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 4
- 241000700605 Viruses Species 0.000 description 4
- 230000016784 immunoglobulin production Effects 0.000 description 4
- 208000015181 infectious disease Diseases 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000008101 lactose Substances 0.000 description 4
- 238000003801 milling Methods 0.000 description 4
- 230000003232 mucoadhesive effect Effects 0.000 description 4
- 229940069328 povidone Drugs 0.000 description 4
- 244000144927 Aloe barbadensis Species 0.000 description 3
- 235000002961 Aloe barbadensis Nutrition 0.000 description 3
- 108090000565 Capsid Proteins Proteins 0.000 description 3
- 102100023321 Ceruloplasmin Human genes 0.000 description 3
- 102000009338 Gastric Mucins Human genes 0.000 description 3
- 108010009066 Gastric Mucins Proteins 0.000 description 3
- 235000011399 aloe vera Nutrition 0.000 description 3
- 238000012512 characterization method Methods 0.000 description 3
- 230000002596 correlated effect Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 239000012634 fragment Substances 0.000 description 3
- 238000001727 in vivo Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 210000003928 nasal cavity Anatomy 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
- 101100454808 Caenorhabditis elegans lgg-2 gene Proteins 0.000 description 2
- 241000714198 Caliciviridae Species 0.000 description 2
- 241000700199 Cavia porcellus Species 0.000 description 2
- 241000124008 Mammalia Species 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 241000699666 Mus <mouse, genus> Species 0.000 description 2
- 241000207746 Nicotiana benthamiana Species 0.000 description 2
- 210000001744 T-lymphocyte Anatomy 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 150000001768 cations Chemical class 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 239000000284 extract Substances 0.000 description 2
- 229940014061 gastric mucins Drugs 0.000 description 2
- 210000004392 genitalia Anatomy 0.000 description 2
- 238000000227 grinding Methods 0.000 description 2
- 230000002458 infectious effect Effects 0.000 description 2
- 210000000936 intestine Anatomy 0.000 description 2
- 238000010255 intramuscular injection Methods 0.000 description 2
- 230000021633 leukocyte mediated immunity Effects 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000004570 mortar (masonry) Substances 0.000 description 2
- 210000004877 mucosa Anatomy 0.000 description 2
- 230000016379 mucosal immune response Effects 0.000 description 2
- 229940031348 multivalent vaccine Drugs 0.000 description 2
- 238000006386 neutralization reaction Methods 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- WNFHGZLVUQBPMA-RMTXHFLUSA-M sodium;(2s,3r,4s,5r)-2,3,4,5-tetrahydroxy-6-oxohexanoate Chemical compound [Na+].O=C[C@H](O)[C@@H](O)[C@@H](O)[C@H](O)C([O-])=O WNFHGZLVUQBPMA-RMTXHFLUSA-M 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 210000001215 vagina Anatomy 0.000 description 2
- 102000040650 (ribonucleotides)n+m Human genes 0.000 description 1
- 206010000087 Abdominal pain upper Diseases 0.000 description 1
- 206010002091 Anaesthesia Diseases 0.000 description 1
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 241000252095 Congridae Species 0.000 description 1
- 241001466947 Desert Shield virus Species 0.000 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 241000206602 Eukaryota Species 0.000 description 1
- 208000005577 Gastroenteritis Diseases 0.000 description 1
- 206010061166 Gastroenteritis bacterial Diseases 0.000 description 1
- 206010017918 Gastroenteritis viral Diseases 0.000 description 1
- 229920002907 Guar gum Polymers 0.000 description 1
- 241001466963 Hawaii calicivirus Species 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 241000700721 Hepatitis B virus Species 0.000 description 1
- 241000701806 Human papillomavirus Species 0.000 description 1
- PQMWYJDJHJQZDE-UHFFFAOYSA-M Methantheline bromide Chemical compound [Br-].C1=CC=C2C(C(=O)OCC[N+](C)(CC)CC)C3=CC=CC=C3OC2=C1 PQMWYJDJHJQZDE-UHFFFAOYSA-M 0.000 description 1
- 206010049565 Muscle fatigue Diseases 0.000 description 1
- 208000000112 Myalgia Diseases 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 241000286253 Norovirus GII.4 Species 0.000 description 1
- 241000714209 Norwalk virus Species 0.000 description 1
- 241000282579 Pan Species 0.000 description 1
- 229920002230 Pectic acid Polymers 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 241000235343 Saccharomycetales Species 0.000 description 1
- 229920002684 Sepharose Polymers 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 241000714208 Southampton virus Species 0.000 description 1
- 238000003917 TEM image Methods 0.000 description 1
- 108020000999 Viral RNA Proteins 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 208000012873 acute gastroenteritis Diseases 0.000 description 1
- 125000003275 alpha amino acid group Chemical group 0.000 description 1
- 229940037003 alum Drugs 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000003190 augmentative effect Effects 0.000 description 1
- 210000003719 b-lymphocyte Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000010364 biochemical engineering Methods 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 239000006172 buffering agent Substances 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000003776 cleavage reaction Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 229910001873 dinitrogen Inorganic materials 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 241001493065 dsRNA viruses Species 0.000 description 1
- 239000002158 endotoxin Substances 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000004508 fractional distillation Methods 0.000 description 1
- 238000012268 genome sequencing Methods 0.000 description 1
- 239000000665 guar gum Substances 0.000 description 1
- 235000010417 guar gum Nutrition 0.000 description 1
- 229960002154 guar gum Drugs 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 230000028996 humoral immune response Effects 0.000 description 1
- 230000008348 humoral response Effects 0.000 description 1
- 230000009851 immunogenic response Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 230000006698 induction Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000010902 jet-milling Methods 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 210000002540 macrophage Anatomy 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 208000013465 muscle pain Diseases 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 230000000474 nursing effect Effects 0.000 description 1
- 239000010318 polygalacturonic acid Substances 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 239000013641 positive control Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 238000003259 recombinant expression Methods 0.000 description 1
- 238000010188 recombinant method Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000007017 scission Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 229920001059 synthetic polymer Polymers 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000004797 therapeutic response Effects 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 238000004627 transmission electron microscopy Methods 0.000 description 1
- 238000002255 vaccination Methods 0.000 description 1
- 210000002845 virion Anatomy 0.000 description 1
- 239000004034 viscosity adjusting agent Substances 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
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
- 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
-
- 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
- A61K39/295—Polyvalent viral antigens; Mixtures of viral and bacterial antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
-
- 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
- A61K2039/5258—Virus-like particles
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
- A61K2039/541—Mucosal route
-
- 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
- A61K2039/55511—Organic adjuvants
- A61K2039/55583—Polysaccharides
-
- 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
- C12N2770/16011—Caliciviridae
- C12N2770/16023—Virus like particles [VLP]
-
- 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
- C12N2770/16011—Caliciviridae
- C12N2770/16034—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
- C12N2770/16011—Caliciviridae
- C12N2770/16071—Demonstrated in vivo effect
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Virology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
【解決手段】 GI genotypeの第1のノロウイルスのウイルス様粒子(VLP)抗原と、GII genotypeの第2のノロウイルスVLP抗原と、アニオン多糖類を含む多価ノロウイルス乾燥粉末ワクチン組成物、ノロウイルス感染に対する免疫を付与する方法および非経口経路による投与と粘膜経路による投与の両方に好適な多価乾燥粉末ノロウイルスワクチン組成物を製造する方法。
【選択図】 図14D
Description
本出願は、2015年8月28日出願の米国仮出願第62/211,289号の優先権を主張するものであり、内容を参照することにより組み込まれる。
ノロウイルス
抗原作製
ワクチン組成物
製造方法
免疫付与方法
実施例1
GIおよびGIIワクチン組成物
実施例2
ワクチン組成物の特性評価
VLP特性評価
GelVac(tm)ワクチン粉末特性評価
ワクチン組成物の免疫原性
GelVac(tm) GIおよびGII粉末の免疫原性
臨床所見
血清抗体応答
血清中和抗体応答
粘膜抗体応答
実施例4
粘膜および非経口経路の両方による免疫付与
実施例5
二価のワクチンによる免疫付与
GelVac GIおよびGII粉末の免疫原性
血清中和抗体応答
粘膜抗体応答
引用文献
[2] Hall AJ, Lopman BA, Payne DC, Patel MM, Gastahaduy PA, Vinje J, et al. Norovirus disease in the United States. Emerg Infect Dis. 2013;19:1198-205.
[3] Mead PS, Slutsker L, Griffin PM, Tauxe RV. Food-related il lness and death in the u nited states reply to dr. hedberg. Emerg Infect Dis. 1999;5:841-2. [4] Patel M M, Widdowson MA, Glass Rl, Akazawa K, Vinje J, Parashar UD. Systematic literature review of role of norovi ruses in sporadic gastroenteritis. Emerg Infect Dis. 2008;14:1224-31.
[5] Yun SI, Kim JK, Song BH, Jeong AY, Jee YM, Lee CH, et al. Complete genome sequence and phylogenetic analysis of a recombinant Korean norovirus, CBNU1, recovered from a 2006 outbreak. Virus Res. 2010;152: 137-52.
[6] Lindesmith LC, Costantini V, Swanstrom J, Debbink K, Donaldson EF, Vinje J, et al. Emergence of a norovirus Gil strain correlates with changes in evolving blockade epitopes. J Virol. 2013;87:2803-13.
[7] Cau l EO. Small round structured viruses: airborne transmission and hospital control. Lancet. 1994;343:1240-2.
[8] Blanton LH, Adams SM, Beard RS, Wei G, Bulens SN, Widdowson MA, et al.
Molecular and epidemiologic trends of caliciviruses associated with outbreaks of acute gastroenteritis in the United States, 2000-2004. J Infect Dis. 2006;193:413-21.
[9] Fankhauser RL, Mon roe SS, Noel JS, Humphrey CD, Bresee JS, Parashar UD, et al.
Epidemiologic and molecular trends of "Norwal k-like viruses" associated with outbreaks of gastroenteritis in the United States. J Infect Dis. 2002;186:1-7.
[10] Zheng DP, Widdowson MA, Glass Rl, Vinje J. Molecular epidemiology of genogrou p l l-genotype 4 norovi ruses in the United States between 1994 and 2006. J Clin Microbiol.
2010;48:168-77.
[11] Donaldson EF, Lindesmith LC, Lobue AD, Baric RS. Norovirus pathogenesis:
mechanisms of persistence and immune evasion in hu man populations. Immunol Rev. 2008;225:190-211.
[12] LoBue AD, Lindesmith L, Yount B, Harrington PR, Thompson JM, Joh nston RE, et al. Multivalent norovirus vaccines induce strong mucosal and systemic blocking antibodies against multiple strains. Vaccine. 2006;24:5220-34.
[13] Sundararajan A, Sangster MY, Frey S, Atmar RL, Chen WH, Ferreira J, et al. Robust mucosal-homing antibody-secreting B cell responses induced by intramuscular administration of adjuvanted bivalent hu man norovirus-like particle vaccine. Vaccine. 2015;33:568-76. [14] Herbst-Kralovetz M, Mason HS, Chen Q. Norwalk virus-like particles as vaccines. Expert Rev Vaccines. 2010;9:299-307.
[15] Tacket CO, Sztein M B, Losonsky GA, Wasserman SS, Estes MK. Humoral, mucosal, and cel lular immune responses to oral Norwalk virus-like particles in volunteers. Clin I mmunol. 2003;108:241-7.
[16] Atmar RL, Bernstein Dl, Harro CD, Al-lbrahim MS, Chen WH, Ferreira J, et al.
Norovirus vaccine against experimental hu man Norwal k Virus illness. N Engl J Med. 2011;365:2178-87.
[17] Reeck A, Kavanagh O, Estes MK, Opekun AR, Gilger MA, Graham DY, et al.
Serological correlate of protection against norovirus-induced gastroenteritis. J Infect Dis. 2010;202:1212-8.
[18] Santi L, Huang Z, Mason H. Virus-like particles production in green plants. Methods. 2006;40:66-76.
[19] White U, Hardy M E, Estes MK. Biochemical characterization of a smaller form of recombinant Norwalk virus capsids assembled in insect cells. J Virol. 1997;71:8066-72.
[20] Velasquez LS, Shira S, Berta AN, Kilbourne J, Medi BM, Tizard I, et al. Intranasal delivery of Norwalk virus-like particles formulated in an in situ gel ling, dry powder vaccine. Vaccine. 2011;29:5221-31.
[21] Parra Gl, Bok K, Taylor R, Haynes J R, Sosnovtsev SV, Richardson C, et al.
I mmunogenicity and specificity of norovirus Consensus Gil virus-like particles in monovalent and bivalent vaccine formulations. Vaccine. 2012;30:3580-6.
[22] Ni YaY, K. M. In-situ Gel Formation of Pectin. In : USPTO, editor. United States: Carrington Laboratories, Inc.; 2004.
[23] Santi L, Batchelor L, Huang Z, Hjelm B, Kilbourne J, Arntzen CJ, et al. An efficient plant viral expression system generating orally immunogenic Norwalk virus-like particles. Vaccine. 2008;26:1846-54.
[24] Biggar KK, Dawson NJ, Storey KB. Real-time protein unfolding: a method for determining the kinetics of native protein denatu ration using a quantitative real-time thermocycler. Biotechniques. 2012;53:231-8. [25] Lindesmith LC, Debbin k K, Swanstrom J, Vinje J, Costantini V, Baric RS, et al.
Monoclonal antibody-based antigenic mapping of norovirus GII-2002. J Virol.
2012;86:873-83.
[26] Koho NM, Mykkanen AK, Reeben M, Raekallio M R, lives M, Poso AR. Sequence variations and two levels of MCTl and CD147 expression in red blood cells and gluteus muscle of horses. Gene. 2012;491:65-70.
[27] Koho T, Mantyla T, Laurin maki P, Huhti L, Butcher SJ, Vesikari T, et al. Purification of norovirus-like particles (VLPs) by ion exchange chromatography. Journal of virological methods. 2012;181:6-11.
[28] Harrington PR, Lindesmith L, Yount B, Moe CL, Baric RS. Binding of Norwalk viruslike particles to ABH histo-blood group antigens is blocked by antisera from infected human volunteers or experimentally vaccinated mice. J Virol. 2002;76:12335-43.
[29] Marionneau S, Ruvoen N, Le Moullac-Vaidye B, Clement M, Cail leau-Thomas A, Ruiz-Palacois G, et al. Norwalk virus binds to histo-blood group antigens present on gastroduodenal epithelial cells of secretor individuals. Gastroenterology.
2002;122:1967-77.
[30] Hansman GS, Natori K, Shirato-Horikoshi H, Ogawa S, Oka T, Katayama K, et al. Genetic and antigenic diversity among noroviruses. The Journal of general virology. 2006;87:909-19.
[31] Parker TD, Kitamoto N, Tanaka T, Hutson AM, Estes MK. Identification of
Genogroup I and Genogroup II broadly reactive epitopes on the norovirus capsid. J Virol. 2005;79:7402-9.
[32] Czako R, Atmar RL, Opekun AR, Gilger MA, Graham DY, Estes MK. Experimental human infection with Norwal k virus elicits a su rrogate neutralizing antibody response with cross-genogroup activity. Clinical and vaccine immunology : CVI. 2015;22:221-8.
[33] Atmar RL, Opekun AR, Gilger MA, Estes MK, Crawford SE, Neill FH, et al.
Determination of the 50% human infectious dose for Norwal k virus. J Infect Dis.
2014;209:1016-22.
[34] Lindesmith LC, Ferris MT, Mullan CW, Ferreira J, Debbink K, Swanstrom J, et al. Broad Blockade Antibody Responses in Human Volunteers after I mmunization with a Multivalent Norovirus VLP Candidate Vaccine: Immunological Analyses from a Phase I Clinical Trial. PLoS Med. 2015;12:el001807.
[35] Bernstein Dl, Atmar RL, Lyon GM, Treanor JJ, Chen WH, Jiang X, et al. Norovirus Vaccine Against Experimental Human Gil Virus Illness: A Challenge Study in Healthy Adults. J Infect Dis. 2015;211:870-8.
[36] Treanor JJ, Atmar RL, Frey SE, Gormley R, Chen WH, Ferreira J, et al. A novel intramuscular bivalent norovirus virus-like particle vaccine candidate-reactogenicity, safety, and immunogenicity in a phase 1 trial in healthy adults. J Infect Dis.
2014;210:1763-71.
[37] Bok K, Parra Gl, Mitra T, Abente E, Shaver CK, Boon D, et al. Chimpanzees as an animal model for hu man norovirus infection and vaccine development. Proc Natl Acad Sci U S A. 2011;108:325-30.
[38] Atmar RL, Bernstein Dl, Lyon GM, Treanor JJ, Al-lbrahim MS, Graham DY, et al. Serological Correlates of Protection against a Gil Norovirus. Clinical and vaccine immunology : CVI. 2015{Lindesmith, 2012 #52}.
[39] Plotkin SA, Orenstein WA, Offit PA. Vaccines. 5th ed. Philadel phia, Pa.:
Saunders/Elsevier; 2008.
[40] Karst SM. Pathogenesis of Noroviruses, Emerging RNA Viruses. Viruses 2010;2:748- 781.
[41] Centers for Disease Control and Prevention, www.cdc.gov/norovirus.
[42] Varshney D, Singh M. Lyophilized Biologies and Vaccines: Modality-Based
Approaches. New York, NY.: Springer; 2015.
均等物
Claims (18)
- GI genotypeの第1のノロウイルスのウイルス様粒子(VLP)抗原と、
GII genotypeの第2のノロウイルスVLP抗原と、
アニオン多糖類と
を含む多価ノロウイルス乾燥粉末ワクチン組成物。 - 請求項1に記載の組成物であって、
前記多価ノロウイルス乾燥粉末ワクチン組成物は、非経口経路による投与と粘膜経路による投与の両方に好適である、組成物。 - 請求項1に記載の組成物であって、
GI genotypeのノロウイルスVLPの量は、乾燥粉末ワクチン組成物20mg当たり、約10μg〜50μgである、組成物。 - 請求項1に記載の組成物であって、
GII genotypeのノロウイルスVLPの量は、乾燥粉末ワクチン組成物20mg当たり、約10μg〜50μgである、組成物。 - 請求項1に記載の組成物であって、
前記アニオン多糖類は、前記組成物の約0.25%の量である、組成物。 - 請求項1に記載の組成物であって、
前記乾燥粉末ワクチン組成物の平均微粒子直径は、24μm〜37μmである、組成物。 - 請求項1に記載の組成物であって、
前記アニオン多糖類は、ポリガラクツロン酸ナトリウムである、組成物。 - 請求項1に記載の組成物であって、
前記GI genotypeのノロウイルスVLPの量とGII genotypeのノロウイルスVLPの量は、1:1〜3:1の割合である、組成物。 - GI genotypeのノロウイルスVLP、GII genotypeのノロウイルスVLP、およびイオン多糖類を含む多価ノロウイルス乾燥粉末ワクチン組成物により、哺乳類対象にノロウイルス感染に対する免疫を付与する方法であって、
前記対象に、少なくとも1用量の前記ワクチン組成物を投与することによって、前記対象のノロウイルス感染に対する能動免疫を与えるのに十分なノロウイルス抗原に対する免疫応答を開始する、方法。 - 請求項9に記載の方法であって、
前記組成物は、粘膜経路および/または非経口経路により投与される、方法。 - 請求項9に記載の方法であって、
水溶液中の前記組成物を再構築することをさらに含み、前記組成物は、非経口経路により投与される、方法。 - 請求項9に記載の方法であって、
少なくとも20mgの組成物は、前記粘膜経路により投与される、方法。 - 請求項9に記載の方法であって、
少なくとも5μgのGI genotypeのノロウイルスVLPおよび5μgのGII genotypeのノロウイルスVLPは、各用量で投与される、方法。 - 請求項9に記載の方法であって、
粘膜経路および/または非経口経路により投与された対象当たりの総用量は、少なくとも50μgのGI genotypeのノロウイルスVLPおよび50μgのGII genotypeのノロウイルスVLPである、方法。 - 非経口経路による投与と粘膜経路による投与の両方に好適な多価乾燥粉末ノロウイルスワクチン組成物を製造する方法であって、
a.GI genotypeのノロウイルスのウイルス様粒子(VLP)抗原を含む第1の溶液を得ることと、
b.前記第1の溶液に、アニオン多糖類を導入することと、
c.前記アニオン多糖類を含む前記第1の溶液を、実質的に非水状態まで乾燥して、第1の乾燥粉末組成物を生成することと、
d.GII genotypeのノロウイルスVLP抗原を含む第2の溶液を得ることと、
e.前記第2の溶液に、アニオン多糖類を導入することと、
f.前記アニオン多糖類を含む前記第2の溶液を、実質的に非水状態まで乾燥して、第2の乾燥粉末組成物を生成することと、
g.前記第1および第2の乾燥粉末組成物を組み合わせて、多価乾燥粉末ノロウイルスワクチン組成物を形成すること
を含む、方法。 - 請求項15に記載の方法であって、
乾燥は、凍結乾燥による、方法。 - 請求項15に記載の方法であって、
乾燥は、スプレー乾燥による、方法。 - 請求項15に記載の方法であって、
前記GI genotypeのノロウイルスVLPおよびGII genotypeのノロウイルスVLPは、組換ウイルス様粒子を、原核細胞、真核細胞、E.coli細胞、出芽酵母(S.cerevisiae)細胞、昆虫細胞、哺乳類細胞、HEK 293細胞、CHO細胞、タバコモザイクウイルスおよびバキュロウイルスからなる群から選択される発現系において、発現することにより得られる、方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562211289P | 2015-08-28 | 2015-08-28 | |
US62/211,289 | 2015-08-28 | ||
PCT/US2016/048940 WO2017040265A1 (en) | 2015-08-28 | 2016-08-26 | Norovirus vaccine |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2018526437A true JP2018526437A (ja) | 2018-09-13 |
JP7033534B2 JP7033534B2 (ja) | 2022-03-10 |
Family
ID=58188108
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2018529513A Active JP7033534B2 (ja) | 2015-08-28 | 2016-08-26 | ノロウイルスワクチン |
Country Status (9)
Country | Link |
---|---|
US (3) | US20180243397A1 (ja) |
EP (1) | EP3341019A4 (ja) |
JP (1) | JP7033534B2 (ja) |
CN (1) | CN108430502A (ja) |
AU (2) | AU2016317661B2 (ja) |
CA (1) | CA3000329A1 (ja) |
IL (1) | IL257653A (ja) |
MX (2) | MX2018002419A (ja) |
WO (1) | WO2017040265A1 (ja) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20180243397A1 (en) | 2015-08-28 | 2018-08-30 | Ron Cobb | Norovirus vaccine |
EP3698773A1 (en) | 2019-02-21 | 2020-08-26 | Università degli Studi di Parma | Composition and manufacturing of powders containing nanoadjuvants for mucosal vaccination |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005506284A (ja) * | 2001-02-28 | 2005-03-03 | カーリントン ラボラトリーズ, インコーポレイテッド | ペクチンのインサイチュゲル化 |
JP2005532987A (ja) * | 2001-11-19 | 2005-11-04 | ベクトン・ディキンソン・アンド・カンパニー | 微粒子形態の薬剤組成物 |
JP2010505766A (ja) * | 2006-09-29 | 2010-02-25 | リゴサイト ファーマスーティカルズ,インコーポレイテッド | ノロウイルスワクチン製剤 |
US20100266636A1 (en) * | 2007-09-18 | 2010-10-21 | Ligocyte Pharmaceuticals, Inc. | Method of conferring a protective immune response to norovirus |
JP2010539192A (ja) * | 2007-09-18 | 2010-12-16 | リゴサイト ファーマスーティカルズ,インコーポレイテッド | ノロウイルスに対して防御免疫応答を付与する方法 |
US20130095134A1 (en) * | 2009-12-23 | 2013-04-18 | Arizona Board Of Regents For And On Behalf Of Arizona State University | Stabilized virus like particles having enhanced mucosal immunogenicity |
WO2015004995A1 (ja) * | 2013-07-12 | 2015-01-15 | 株式会社Umnファーマ | ノロウイルスのウイルス様粒子を含む医薬組成物 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7022683B1 (en) | 1998-05-13 | 2006-04-04 | Carrington Laboratories, Inc. | Pharmacological compositions comprising pectins having high molecular weights and low degrees of methoxylation |
US7494669B2 (en) | 2001-02-28 | 2009-02-24 | Carrington Laboratories, Inc. | Delivery of physiological agents with in-situ gels comprising anionic polysaccharides |
US8074906B2 (en) | 2005-07-07 | 2011-12-13 | Nanotherapeutics, Inc. | Process for milling and preparing powders and compositions produced thereby |
JP5215865B2 (ja) * | 2005-11-22 | 2013-06-19 | ノバルティス ヴァクシンズ アンド ダイアグノスティクス インコーポレイテッド | ノロウイルス抗原およびサポウイルス抗原 |
WO2009015286A2 (en) * | 2007-07-24 | 2009-01-29 | Nexbio, Inc. | Technology for the preparation of microparticles |
CN104911154A (zh) * | 2008-08-08 | 2015-09-16 | 武田疫苗股份有限公司 | 交叉反应性增强的包含复合衣壳氨基酸序列的病毒样颗粒 |
JOP20130186B1 (ar) * | 2012-06-22 | 2021-08-17 | Takeda Vaccines Montana Inc | تنقية الجزيئات الشبيهة بالفيروسات |
US20180243397A1 (en) | 2015-08-28 | 2018-08-30 | Ron Cobb | Norovirus vaccine |
-
2016
- 2016-08-26 US US15/754,807 patent/US20180243397A1/en not_active Abandoned
- 2016-08-26 EP EP16842675.7A patent/EP3341019A4/en active Pending
- 2016-08-26 CA CA3000329A patent/CA3000329A1/en not_active Abandoned
- 2016-08-26 MX MX2018002419A patent/MX2018002419A/es unknown
- 2016-08-26 WO PCT/US2016/048940 patent/WO2017040265A1/en active Application Filing
- 2016-08-26 AU AU2016317661A patent/AU2016317661B2/en active Active
- 2016-08-26 JP JP2018529513A patent/JP7033534B2/ja active Active
- 2016-08-26 CN CN201680057044.5A patent/CN108430502A/zh active Pending
-
2018
- 2018-02-21 IL IL257653A patent/IL257653A/en unknown
- 2018-02-26 MX MX2022013035A patent/MX2022013035A/es unknown
-
2020
- 2020-05-18 US US16/877,015 patent/US11596680B2/en active Active
-
2023
- 2023-02-02 US US18/163,855 patent/US20230330205A1/en active Pending
- 2023-08-11 AU AU2023214369A patent/AU2023214369A1/en not_active Abandoned
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005506284A (ja) * | 2001-02-28 | 2005-03-03 | カーリントン ラボラトリーズ, インコーポレイテッド | ペクチンのインサイチュゲル化 |
JP2005532987A (ja) * | 2001-11-19 | 2005-11-04 | ベクトン・ディキンソン・アンド・カンパニー | 微粒子形態の薬剤組成物 |
JP2010505766A (ja) * | 2006-09-29 | 2010-02-25 | リゴサイト ファーマスーティカルズ,インコーポレイテッド | ノロウイルスワクチン製剤 |
US20100266636A1 (en) * | 2007-09-18 | 2010-10-21 | Ligocyte Pharmaceuticals, Inc. | Method of conferring a protective immune response to norovirus |
JP2010539192A (ja) * | 2007-09-18 | 2010-12-16 | リゴサイト ファーマスーティカルズ,インコーポレイテッド | ノロウイルスに対して防御免疫応答を付与する方法 |
US20130095134A1 (en) * | 2009-12-23 | 2013-04-18 | Arizona Board Of Regents For And On Behalf Of Arizona State University | Stabilized virus like particles having enhanced mucosal immunogenicity |
WO2015004995A1 (ja) * | 2013-07-12 | 2015-01-15 | 株式会社Umnファーマ | ノロウイルスのウイルス様粒子を含む医薬組成物 |
Non-Patent Citations (2)
Title |
---|
VACCINE (2011) VOL.29, ISSUE 32, P.5221-5231, JPN6020016377, ISSN: 0004463244 * |
VACCINE (JAN 2015) VOL.33, ISSUE 4, P.568-576, JPN6020016378, ISSN: 0004463245 * |
Also Published As
Publication number | Publication date |
---|---|
AU2016317661B2 (en) | 2023-05-18 |
EP3341019A1 (en) | 2018-07-04 |
MX2022013035A (es) | 2022-11-09 |
AU2023214369A1 (en) | 2023-08-31 |
US20230330205A1 (en) | 2023-10-19 |
US11596680B2 (en) | 2023-03-07 |
US20180243397A1 (en) | 2018-08-30 |
CN108430502A (zh) | 2018-08-21 |
CA3000329A1 (en) | 2017-03-09 |
IL257653A (en) | 2018-04-30 |
EP3341019A4 (en) | 2019-07-31 |
JP7033534B2 (ja) | 2022-03-10 |
AU2016317661A1 (en) | 2018-03-15 |
MX2018002419A (es) | 2018-11-29 |
US20200345828A1 (en) | 2020-11-05 |
WO2017040265A1 (en) | 2017-03-09 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20230330205A1 (en) | Norovirus vaccine | |
AU2015200836B2 (en) | Parenteral norovirus vaccine formulations | |
JP5898133B2 (ja) | ノロウイルスワクチン製剤 | |
ES2668836T3 (es) | Partículas similivíricas que comprenden secuencias de aminoácidos de la cápside compuestas para reactividad cruzada potenciada | |
CN108624601B (zh) | 酵母表达的柯萨奇病毒a10病毒样颗粒及其应用 | |
US20180340181A1 (en) | Vaccines against zika virus based on zika structure proteins | |
JP2023549017A (ja) | 多価担体および関連するワクチン組成物 | |
Heinimäki et al. | Combination of three virus-derived nanoparticles as a vaccine against enteric pathogens; enterovirus, norovirus and rotavirus | |
Heinimäki et al. | Antigenicity and immunogenicity of HA2 and M2e influenza virus antigens conjugated to norovirus-like, VP1 capsid-based particles by the SpyTag/SpyCatcher technology | |
US20220054621A1 (en) | Norovirus vaccine formulations and methods | |
Springer et al. | Preclinical dose-ranging studies of a novel dry powder norovirus vaccine formulation | |
JP5837500B2 (ja) | ライノウイルスの感染の治療および予防のための薬学的組成物 | |
US9439958B2 (en) | Stabilized virus like particles having enhanced mucosal immunogenicity | |
Yang et al. | Construction and immune effect evaluation of the S protein heptad repeat-based nanoparticle vaccine against porcine epidemic diarrhea virus | |
US20220409717A1 (en) | Chikungunya virus-like particle vaccine and methods of using the same | |
CN107400662B (zh) | 源于肠道病毒71型的新型病毒样颗粒及其应用 | |
Chang et al. | A Novel Double Mosaic Virus-like Particle-Based Vaccine against SARS-CoV-2 Incorporates Both Receptor Binding Motif (RBM) and Fusion Domain. Vaccines 2021, 9, 1287 | |
CN116514991A (zh) | 一种β冠状病毒和流感嵌合抗原、其制备方法和应用 | |
Peng et al. | Extensive neutralization against SARS-CoV-2 variants elicited by Omicron-specific subunit vaccine booster 2 | |
Farnós et al. | Virus-like particles of the Rabbit Hemorrhagic Disease Virus obtained in yeast are able to induce protective immunity against classical strains and a viral subtype circulating in Cuba | |
Botha et al. | The human papilloma virus (HPV) prophylactic vaccine: guidelines | |
CN106110317A (zh) | 肺炎球菌‑百白破联合疫苗 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20190614 |
|
A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20200526 |
|
A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20200824 |
|
A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20201026 |
|
A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20210316 |
|
A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20210614 |
|
A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20210907 |
|
RD02 | Notification of acceptance of power of attorney |
Free format text: JAPANESE INTERMEDIATE CODE: A7422 Effective date: 20210907 |
|
A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20211014 |
|
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: 20220201 |
|
A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20220228 |
|
R150 | Certificate of patent or registration of utility model |
Ref document number: 7033534 Country of ref document: JP Free format text: JAPANESE INTERMEDIATE CODE: R150 |