HRP20120013T1 - Intranazalno cjepivo za gripu bazirano na virosomima - Google Patents
Intranazalno cjepivo za gripu bazirano na virosomima Download PDFInfo
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- HRP20120013T1 HRP20120013T1 HR20120013T HRP20120013T HRP20120013T1 HR P20120013 T1 HRP20120013 T1 HR P20120013T1 HR 20120013 T HR20120013 T HR 20120013T HR P20120013 T HRP20120013 T HR P20120013T HR P20120013 T1 HRP20120013 T1 HR P20120013T1
- Authority
- HR
- Croatia
- Prior art keywords
- influenza
- virosomes
- preparation
- elderly
- adults
- Prior art date
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- 239000000277 virosome Substances 0.000 title claims abstract 10
- 229960003971 influenza vaccine Drugs 0.000 title claims 3
- 206010022000 influenza Diseases 0.000 claims abstract 10
- 101710154606 Hemagglutinin Proteins 0.000 claims abstract 6
- 102000005348 Neuraminidase Human genes 0.000 claims abstract 6
- 108010006232 Neuraminidase Proteins 0.000 claims abstract 6
- 101710093908 Outer capsid protein VP4 Proteins 0.000 claims abstract 6
- 101710135467 Outer capsid protein sigma-1 Proteins 0.000 claims abstract 6
- 101710176177 Protein A56 Proteins 0.000 claims abstract 6
- 239000000427 antigen Substances 0.000 claims abstract 6
- 102000036639 antigens Human genes 0.000 claims abstract 6
- 108091007433 antigens Proteins 0.000 claims abstract 6
- 239000000185 hemagglutinin Substances 0.000 claims abstract 6
- 241000712461 unidentified influenza virus Species 0.000 claims abstract 5
- 230000001939 inductive effect Effects 0.000 claims abstract 4
- 239000000203 mixture Substances 0.000 claims abstract 4
- 150000002632 lipids Chemical class 0.000 claims abstract 3
- 230000007108 local immune response Effects 0.000 claims abstract 3
- 239000002245 particle Substances 0.000 claims abstract 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract 3
- 230000009885 systemic effect Effects 0.000 claims abstract 3
- 230000028993 immune response Effects 0.000 claims 4
- GNENVASJJIUNER-UHFFFAOYSA-N 2,4,6-tricyclohexyloxy-1,3,5,2,4,6-trioxatriborinane Chemical compound C1CCCCC1OB1OB(OC2CCCCC2)OB(OC2CCCCC2)O1 GNENVASJJIUNER-UHFFFAOYSA-N 0.000 claims 2
- 238000006243 chemical reaction Methods 0.000 claims 2
- 231100000433 cytotoxic Toxicity 0.000 claims 2
- 230000001472 cytotoxic effect Effects 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 210000004779 membrane envelope Anatomy 0.000 claims 2
- 230000004044 response Effects 0.000 claims 2
- 229960005486 vaccine Drugs 0.000 claims 2
- 239000003937 drug carrier Substances 0.000 claims 1
- 210000004698 lymphocyte Anatomy 0.000 claims 1
- 230000000527 lymphocytic effect Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000003612 virological effect Effects 0.000 claims 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
- A61K39/145—Orthomyxoviridae, e.g. influenza virus
-
- 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
- A61K39/39—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
- A61P11/00—Drugs for disorders of the respiratory system
-
- 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
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- 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
- A61K2039/5258—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
- A61K2039/543—Mucosal route intranasal
-
- 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
- A61K2039/55516—Proteins; Peptides
-
- 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
- C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16111—Influenzavirus A, i.e. influenza A virus
- C12N2760/16134—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
- C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16211—Influenzavirus B, i.e. influenza B virus
- C12N2760/16234—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Virology (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Pulmonology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Molecular Biology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Abstract
Pripravak koji sadrži virosome gripe koji sadrže rekonstituirane ovojnice virusa gripe za uporabu kod induciranja sistemskog i/ili lokalnog imunog odgovora protiv antigena gripe hemaglutinina i/ili neuraminidaze ili njihovih derivata kod čovjeka putem jednostrukog intranazalnog ili inhalacijskog davanje, naznačen time davirusne ovojnice su u potpunosti dobivene od virusnih čestica gripe, nikakav lipid nije dodan iz vanjskog izvora u rekonstituirane virosome, virosomi sadrže antigene gripe hemaglutinin i/ili neuraminidazu ili njihove derivate, tenikakva odvojena pomoćna tvar i/ili imuno stimulator nisu dodani u pripravak. Patent sadrži još 8 patentnih zahtjeva.
Claims (9)
1. Pripravak koji sadrži virosome gripe koji sadrže rekonstituirane ovojnice virusa gripe za uporabu kod induciranja sistemskog i/ili lokalnog imunog odgovora protiv antigena gripe hemaglutinina i/ili neuraminidaze ili njihovih derivata kod čovjeka putem jednostrukog intranazalnog ili inhalacijskog davanje, naznačen time da
• virusne ovojnice su u potpunosti dobivene od virusnih čestica gripe,
• nikakav lipid nije dodan iz vanjskog izvora u rekonstituirane virosome,
• virosomi sadrže antigene gripe hemaglutinin i/ili neuraminidazu ili njihove derivate, te
• nikakva odvojena pomoćna tvar i/ili imuno stimulator nisu dodani u pripravak.
2. Pripravak prema zahtjevu 1, naznačen time da je također za uporabu kod induciranja citotoksičnog limfocitnog odgovora.
3. Pripravak prema bilo kojem od zahtjeva 1 do 2, naznačen time da je imuni odgovor u skladu sa CHMP kriterijem za cjepivo za gripu.
4. Pripravak prema zahtjevu 3, naznačen time da imuni odgovor daje jednu ili više od stopa sero-zaštite od > 70% za odrasle i/ili > 60% za starije osobe, stopu sero-konverzije od > 40% za odrasle i/ili> 30% za starije osobe, te srednje povećanje > 2.5-struko za odrasle i/ili > 2.0-struko za starije osobe.
5. Pripravak prema bilo kojem od zahtjeva 1 do 4 naznačen time da je pripravak za uporabu kao formulacija cjepiva koje sadrži farmaceutski nosač za uporabu kod intranazalnog ili inhalacijskog davanja.
6. Uporaba pripravka koji sadrži virosome gripe koji sadrži rekonstituirane ovojnice virusa gripe, za proizvodnju formulacije cjepiva za jednostruko intranazalno ili inhalacijsko davanje kod induciranja sistemskog i/ili lokalnog imunog odgovora protiv antigena gripe hemaglutinina i/ili neuraminidaze ili njihovih derivata kod čovjeka, naznačena time da
• su virusne ovojnice u potpunosti dobivene od virusnih čestica gripe,
• nikakav lipid nije dodan iz vanjskog izvora u rekonstituirane virosome,
• virosomi sadrže antigene gripe hemaglutinin i/ili neuraminidazu ili njihove derivate, te
• nikakva odvojena pomoćna tvar i/ili imuno stimulator nisu dodani u pripravak.
7. Uporaba prema zahtjevu 6, naznačena time da jednostruko intranazalno ili inhalacijsko davanje pripravka također inducira citotoksični limfocitni odgovor.
8. Uporaba prema bilo kojem od zahtjeva 6 do 7, naznačena time da je imuni odgovor u skladu sa CHMP kriterijem za cjepivo za gripu.
9. Uporaba prema zahtjevu 8, naznačen time da imuni odgovor daje jednu ili više od stopa sero-zaštite od >70% za odrasle i/ili >60% za starije osobe, stopu sero-konverzije od > 40% za odrasle i/ili >30% za starije osobe, te srednje povećanje > 2.5-struko za odrasle i/ili >2.0-struko za starije osobe.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US78446206P | 2006-03-22 | 2006-03-22 | |
| EP06111534 | 2006-03-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20120013T1 true HRP20120013T1 (hr) | 2012-01-31 |
Family
ID=38038698
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20100144T HRP20100144T1 (hr) | 2006-03-22 | 2010-03-12 | Intranazalno ili inhalacijsko davanje virosoma |
| HR20120013T HRP20120013T1 (hr) | 2006-03-22 | 2012-01-05 | Intranazalno cjepivo za gripu bazirano na virosomima |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20100144T HRP20100144T1 (hr) | 2006-03-22 | 2010-03-12 | Intranazalno ili inhalacijsko davanje virosoma |
Country Status (21)
| Country | Link |
|---|---|
| EP (2) | EP1996229B1 (hr) |
| JP (1) | JP5285595B2 (hr) |
| KR (1) | KR20090016659A (hr) |
| AR (1) | AR059972A1 (hr) |
| AT (2) | ATE451931T1 (hr) |
| AU (1) | AU2007228736B2 (hr) |
| BR (1) | BRPI0709864A2 (hr) |
| CA (1) | CA2646895A1 (hr) |
| DE (1) | DE602007003815D1 (hr) |
| DK (2) | DK1996229T3 (hr) |
| EA (1) | EA014532B1 (hr) |
| ES (2) | ES2338382T3 (hr) |
| HR (2) | HRP20100144T1 (hr) |
| IL (1) | IL193840A (hr) |
| MY (1) | MY142996A (hr) |
| NO (1) | NO20084452L (hr) |
| PL (2) | PL1996229T3 (hr) |
| PT (2) | PT2158921E (hr) |
| SA (1) | SA07280116B1 (hr) |
| SI (2) | SI1996229T1 (hr) |
| WO (1) | WO2007107585A1 (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2009276304B2 (en) * | 2008-08-01 | 2012-10-11 | Gamma Vaccines Pty Limited | Influenza vaccines |
| BR112013010830A2 (pt) * | 2010-11-02 | 2017-12-12 | Hector Manuel Zepeda Lopez | vacina inovadoras contra o vírus da influenza pandêmica a/h1n1 |
| US11523988B2 (en) | 2018-11-29 | 2022-12-13 | Catalent U.K. Swindon Zydis Limited | Oral dispersible vaccine comprising virosomes |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9018690D0 (en) * | 1990-08-24 | 1990-10-10 | Wellcome Found | Vaccines |
| EP1447080A1 (en) * | 2003-02-13 | 2004-08-18 | Bestewil Holding B.V. | Method for producing virosome-like particles |
| AR056245A1 (es) * | 2003-06-19 | 2007-10-03 | Bestewil Holding Bv | Membranas virales reconstituidas funcionales que contienen un coadyuvante |
-
2007
- 2007-03-20 AR ARP070101114A patent/AR059972A1/es not_active Application Discontinuation
- 2007-03-21 EP EP07727166A patent/EP1996229B1/en active Active
- 2007-03-21 PT PT09178084T patent/PT2158921E/pt unknown
- 2007-03-21 WO PCT/EP2007/052690 patent/WO2007107585A1/en active Application Filing
- 2007-03-21 PL PL07727166T patent/PL1996229T3/pl unknown
- 2007-03-21 DK DK07727166.6T patent/DK1996229T3/da active
- 2007-03-21 KR KR1020087025693A patent/KR20090016659A/ko not_active Application Discontinuation
- 2007-03-21 ES ES07727166T patent/ES2338382T3/es active Active
- 2007-03-21 SI SI200730184T patent/SI1996229T1/sl unknown
- 2007-03-21 JP JP2009500864A patent/JP5285595B2/ja not_active Expired - Fee Related
- 2007-03-21 SI SI200730842T patent/SI2158921T1/sl unknown
- 2007-03-21 ES ES09178084T patent/ES2375436T3/es active Active
- 2007-03-21 MY MYPI20083534A patent/MY142996A/en unknown
- 2007-03-21 EP EP09178084A patent/EP2158921B1/en active Active
- 2007-03-21 DK DK09178084.1T patent/DK2158921T3/da active
- 2007-03-21 SA SA07280116A patent/SA07280116B1/ar unknown
- 2007-03-21 EA EA200870361A patent/EA014532B1/ru not_active IP Right Cessation
- 2007-03-21 DE DE602007003815T patent/DE602007003815D1/de active Active
- 2007-03-21 PL PL09178084T patent/PL2158921T3/pl unknown
- 2007-03-21 AT AT07727166T patent/ATE451931T1/de active
- 2007-03-21 AT AT09178084T patent/ATE539766T1/de active
- 2007-03-21 BR BRPI0709864-2A patent/BRPI0709864A2/pt not_active IP Right Cessation
- 2007-03-21 PT PT07727166T patent/PT1996229E/pt unknown
- 2007-03-21 AU AU2007228736A patent/AU2007228736B2/en not_active Ceased
- 2007-03-21 CA CA002646895A patent/CA2646895A1/en not_active Abandoned
-
2008
- 2008-09-02 IL IL193840A patent/IL193840A/en not_active IP Right Cessation
- 2008-10-22 NO NO20084452A patent/NO20084452L/no not_active Application Discontinuation
-
2010
- 2010-03-12 HR HR20100144T patent/HRP20100144T1/hr unknown
-
2012
- 2012-01-05 HR HR20120013T patent/HRP20120013T1/hr unknown
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