HRP20100144T1 - Intranazalno ili inhalacijsko davanje virosoma - Google Patents
Intranazalno ili inhalacijsko davanje virosoma Download PDFInfo
- Publication number
- HRP20100144T1 HRP20100144T1 HR20100144T HRP20100144T HRP20100144T1 HR P20100144 T1 HRP20100144 T1 HR P20100144T1 HR 20100144 T HR20100144 T HR 20100144T HR P20100144 T HRP20100144 T HR P20100144T HR P20100144 T1 HRP20100144 T1 HR P20100144T1
- Authority
- HR
- Croatia
- Prior art keywords
- intranasal
- influenza
- preparation
- virosomes
- inhalation administration
- Prior art date
Links
- 239000000277 virosome Substances 0.000 title claims abstract 11
- 229960003971 influenza vaccine Drugs 0.000 title claims 2
- 206010022000 influenza Diseases 0.000 claims abstract 11
- 241000700605 Viruses Species 0.000 claims abstract 8
- 239000000203 mixture Substances 0.000 claims abstract 8
- 102000005348 Neuraminidase Human genes 0.000 claims abstract 6
- 108010006232 Neuraminidase Proteins 0.000 claims abstract 6
- 230000003612 virological effect Effects 0.000 claims abstract 6
- 101710154606 Hemagglutinin Proteins 0.000 claims abstract 3
- 101710093908 Outer capsid protein VP4 Proteins 0.000 claims abstract 3
- 101710135467 Outer capsid protein sigma-1 Proteins 0.000 claims abstract 3
- 101710176177 Protein A56 Proteins 0.000 claims abstract 3
- 239000002671 adjuvant Substances 0.000 claims abstract 3
- 239000000427 antigen Substances 0.000 claims abstract 3
- 102000036639 antigens Human genes 0.000 claims abstract 3
- 108091007433 antigens Proteins 0.000 claims abstract 3
- 239000000185 hemagglutinin Substances 0.000 claims abstract 3
- 150000002632 lipids Chemical class 0.000 claims abstract 3
- 230000007108 local immune response Effects 0.000 claims abstract 3
- 210000004779 membrane envelope Anatomy 0.000 claims abstract 3
- 239000002245 particle Substances 0.000 claims abstract 3
- 230000009885 systemic effect Effects 0.000 claims abstract 3
- 238000004519 manufacturing process Methods 0.000 claims abstract 2
- 241000712461 unidentified influenza virus Species 0.000 claims abstract 2
- 238000009472 formulation Methods 0.000 claims 5
- 229960005486 vaccine Drugs 0.000 claims 5
- 230000001939 inductive effect Effects 0.000 claims 3
- 230000028993 immune response Effects 0.000 claims 2
- 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 1
- 231100000433 cytotoxic Toxicity 0.000 claims 1
- 230000001472 cytotoxic effect Effects 0.000 claims 1
- 210000004698 lymphocyte Anatomy 0.000 claims 1
- 230000004044 response Effects 0.000 claims 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
- 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
Landscapes
- 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
Upotreba virosoma gripe formiranih od rekonstituiranog omotača navedenog virusa, u proizvodnji pripravka za jedno intranazalno davanje čovjeku, koji su sposobni izazvati sustavan i/ili lokalan imunološki odgovor protiv antigena hemaglutinina i/ili neuraminidaza gripe ili njihovih derivata, te se navedeni pripravak sastoji od virosoma gripe formiranih od rekonstituiranog omotača navedenog virusa, pri čemu:• virusni omotači su u cijelosti dobiveni od virusnih čestica gripe, • ne dodaju se lipidi iz vanjskog izvora rekonstituiranim virosomima, • virosomi se sastoje od haemaglutinina i/ili neuraminidaza gripe ili njihovih derivata, • doza haemaglutinina po virusnom soju po jednom intranazalnom ili inhalacijskom davanju je manja ili jednaka 30 µg, naznačena time da nema odvojenog dodavanja adjuvanta i/ili imunološkog stimulatora u pripravak. Patent sadrži još 14 patentnih zahtjeva.
Claims (15)
1. Upotreba virosoma gripe formiranih od rekonstituiranog omotača navedenog virusa, u proizvodnji pripravka za jedno intranazalno davanje čovjeku, koji su sposobni izazvati sustavan i/ili lokalan imunološki odgovor protiv antigena hemaglutinina i/ili neuraminidaza gripe ili njihovih derivata, te se navedeni pripravak sastoji od virosoma gripe formiranih od rekonstituiranog omotača navedenog virusa, pri čemu:
• virusni omotači su u cijelosti dobiveni od virusnih čestica gripe,
• ne dodaju se lipidi iz vanjskog izvora rekonstituiranim virosomima,
• virosomi se sastoje od haemaglutinina i/ili neuraminidaza gripe ili njihovih derivata,
• doza haemaglutinina po virusnom soju po jednom intranazalnom ili inhalacijskom davanju je manja ili jednaka 30 µg,
naznačena time da nema odvojenog dodavanja adjuvanta i/ili imunološkog stimulatora u pripravak.
2. Pripravak za jedno intranazalno davanje čovjeku, koji pripravak je sposoban izazvati sustavan i/ili lokalan imunološki odgovor protiv antigena hemaglutinina i/ili neuraminidaza gripe ili njihovih derivata, te se navedeni pripravak sastoji od virosoma gripe formiranih od rekonstituiranog omotača navedenog virusa, pri čemu:
• virusni omotači su u cijelosti dobiveni od virusnih čestica gripe,
• ne dodaju se lipidi iz vanjskog izvora rekonstituiranim virosomima,
• virosomi se sastoje od haemaglutinina i/ili neuraminidaza gripe ili njihovih derivata,
• doza haemaglutinina po virusnom soju po jednom intranazalnom ili inhalacijskom davanju je manja ili jednaka 30 µg,
naznačen time da nema odvojenog dodavanja adjuvanta i/ili imunološkog stimulatora u pripravak.
3. Upotreba pripravka prema patentnom zahtjevu 1 ili 2, naznačena time da pojedinačno intranazalno ili inhalacijsko davanje formulacije je također sposobno za induciranje citotoksičnog limfocitnog odgovora.
4. Upotreba pripravka prema bilo kojem patentnom zahtjevu 1 do 3, naznačena time da je imunološki odgovor u skladu s CHMP kriterijima za cjepivo protiv gripe.
5. Upotreba pripravka prema patentnom zahtjevu 4, naznačena time da imunološki odgovor pruža jednu ili više od serozaštitnih stopa od >70% za odrasle i/ili >60% za starije osobe, serokonverzijsku stopu od >40% za odrasle i/ili >30% za starije osobe, te srednje povećanje > 2.5 puta za odrasle i/ili> 2.0 puta za starije osobe.
6. Upotreba pripravka prema bilo kojem patentnom zahtjevu 1 do 5, naznačena time da je doza hemagultinina po virusnom soju po intranazalnom ili inhalacijskom davanju manja od ili jednaka 25 µg.
7. Upotreba pripravka prema bilo kojem patentnom zahtjevu 1 do 5, naznačena time da je doza hemagultinina po virusnom soju po intranazalnom ili inhalacijskom davanju manja od ili jednaka 20 µg.
8. Upotreba pripravka prema bilo kojem patentnom zahtjevu 1 do 5, naznačena time da je doza hemagultinina po virusnom soju po intranazalnom ili inhalacijskom davanju manja od ili jednaka 15 µg.
9. Upotreba pripravka prema bilo kojem patentnom zahtjevu 1 do 5, naznačena time da je doza hemagultinina po virusnom soju po intranazalnom ili inhalacijskom davanju manja od ili jednaka 10 µg.
10. Upotreba pripravka prema bilo kojem patentnom zahtjevu 1 do 5, naznačena time da je doza hemagultinina po virusnom soju po intranazalnom ili inhalacijskom davanju manja od ili jednaka 5 µg.
11. Upotreba prema bilo kojem patentnom zahtjevu 1 ili 3 do 9, naznačena time da je pripravak koji se dobiva formulacija cjepiva.
12. Formulacija cjepiva, naznačena time da sadrži pripravak prema bilo kojem od zahtjeva 2 ili 3-9.
13. Naprava za intranazalno ili inhalacijsko davanje naznačena time da sadrži formulaciju cjepiva prema zahtjevu 12 i mehanizam za aerosolizaciju cjepiva.
14. Naprava prema patentnom zahtjevu 13, naznačena time da naprava sadrži količinu formulacije cjepiva za jedno intranazalno ili inhalacijsko davanje.
15. Naprava prema bilo kojem od zahtjeva 13 ili 14, naznačena time da je naprava za jednokratnu upotrebu.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US78446206P | 2006-03-22 | 2006-03-22 | |
| EP06111534 | 2006-03-22 | ||
| PCT/EP2007/052690 WO2007107585A1 (en) | 2006-03-22 | 2007-03-21 | Intranasal influenza vaccine based on virosomes |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20100144T1 true HRP20100144T1 (hr) | 2010-04-30 |
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 After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20120013T HRP20120013T1 (hr) | 2006-03-22 | 2012-01-05 | Intranazalno cjepivo za gripu bazirano na virosomima |
Country Status (21)
| Country | Link |
|---|---|
| EP (2) | EP2158921B1 (hr) |
| JP (1) | JP5285595B2 (hr) |
| KR (1) | KR20090016659A (hr) |
| AR (1) | AR059972A1 (hr) |
| AT (2) | ATE539766T1 (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 |
|---|---|---|---|---|
| RU2011107757A (ru) * | 2008-08-01 | 2012-09-10 | Гамма Ваксинс Пти Лимитед (Au) | Вакцины против гриппа |
| KR20130140050A (ko) * | 2010-11-02 | 2013-12-23 | 헥토 마뉴엘 제페다 로페즈 | Ａ/ｈ1ｎ1 범유행 인플루엔자 바이러스에 대한 신규한 백신 |
| 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 AT AT09178084T patent/ATE539766T1/de active
- 2007-03-21 PT PT09178084T patent/PT2158921E/pt unknown
- 2007-03-21 KR KR1020087025693A patent/KR20090016659A/ko not_active Application Discontinuation
- 2007-03-21 JP JP2009500864A patent/JP5285595B2/ja not_active Expired - Fee Related
- 2007-03-21 EA EA200870361A patent/EA014532B1/ru not_active IP Right Cessation
- 2007-03-21 SI SI200730184T patent/SI1996229T1/sl unknown
- 2007-03-21 PT PT07727166T patent/PT1996229E/pt unknown
- 2007-03-21 EP EP09178084A patent/EP2158921B1/en active Active
- 2007-03-21 WO PCT/EP2007/052690 patent/WO2007107585A1/en active Application Filing
- 2007-03-21 DE DE602007003815T patent/DE602007003815D1/de active Active
- 2007-03-21 MY MYPI20083534A patent/MY142996A/en unknown
- 2007-03-21 AT AT07727166T patent/ATE451931T1/de active
- 2007-03-21 BR BRPI0709864-2A patent/BRPI0709864A2/pt not_active IP Right Cessation
- 2007-03-21 EP EP07727166A patent/EP1996229B1/en active Active
- 2007-03-21 DK DK07727166.6T patent/DK1996229T3/da active
- 2007-03-21 DK DK09178084.1T patent/DK2158921T3/da active
- 2007-03-21 ES ES07727166T patent/ES2338382T3/es active Active
- 2007-03-21 AU AU2007228736A patent/AU2007228736B2/en not_active Ceased
- 2007-03-21 SI SI200730842T patent/SI2158921T1/sl unknown
- 2007-03-21 ES ES09178084T patent/ES2375436T3/es active Active
- 2007-03-21 SA SA07280116A patent/SA07280116B1/ar unknown
- 2007-03-21 PL PL07727166T patent/PL1996229T3/pl unknown
- 2007-03-21 PL PL09178084T patent/PL2158921T3/pl unknown
- 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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