DK2432502T3 - Stabile, sprøjtetørrede, immunogene, virussammensætninger - Google Patents

Stabile, sprøjtetørrede, immunogene, virussammensætninger Download PDF

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DK2432502T3
DK2432502T3 DK10778366.4T DK10778366T DK2432502T3 DK 2432502 T3 DK2432502 T3 DK 2432502T3 DK 10778366 T DK10778366 T DK 10778366T DK 2432502 T3 DK2432502 T3 DK 2432502T3
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virus
viruses
immunogenic composition
vaccine
vol
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DK10778366.4T
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Tom Han Jin
Eric I-Fu Tsao
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Aeras
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61P31/04—Antibacterial agents
    • 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
    • A61P31/04—Antibacterial agents
    • A61P31/06—Antibacterial agents for tuberculosis
    • 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
    • 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
    • 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
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
    • A61P33/06—Antimalarials
    • 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
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    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86—Viral vectors
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    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • 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
    • A61K2039/5256—Virus expressing foreign proteins
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    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10334—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10341—Use of virus, viral particle or viral elements as a vector
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    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10351—Methods of production or purification of viral material
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    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10361—Methods of inactivation or attenuation
    • 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
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    • 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

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Claims (15)

1. Immunogen sammensætning, omfattende: en eller flere levende virusser i en pulverformulering sprøjtetørret fra en sammensætning omfattende mannitol ved 50-100 mg/ml, cyclodextrin ved 0,2-1 mg/ml, trehalose ved 0,5-5 mg/ml, og dextran ved 0,5-5 mg/ml, hvor virussen er svækket virus egnet til anvendelse som en vaccine valgt fra poliovirus, rotavirus, orthomyxovirus inklusiv influenzavirusser, retrovirus inklusiv RSV, koppevirus, inklusiv vaccinia, parvovirus inklusiv adeno-associerede virusser, papilllomaviridae, inklusiv HPV, herpesvirus inklusiv EBV, CMV eller herpes simplex-virus, lentivirus.
2. Den immunogene sammensætning ifølge krav 1, hvor nævnte cyclodextrin inkluderer en eller flere af a- eller β- eller y-cyclodextrin.
3. Den immunogene sammensætning ifølge krav 1, hvor nævnte dextran har en molekylevægt i området fra 25K til 500K.
4. Den immunogene sammensætning ifølge krav 3, hvor nævnte dextran har molekylevægt i området fra 40K til 90K.
5. Den immunogene sammensætning ifølge krav 1 yderligere omfattende buffermidler.
6. Den immunogene sammensætning ifølge krav 1, hvor nævnte en eller flere virusser inkluderer mindst en virus, der er en genetisk modificeret virus-vaccine vektor, der koder for et eller flere passager-gener, der er fremmede for nævnte genetisk modificerede virus-vaccine vektor, fortrinsvis hvor nævnte virus vaccinevektor er ikke-replikerende eller replikationsdefekt, i særdeleshed, hvor nævnte virus-vaccine er en adenovirus.
7. Den immunogene sammensætning ifølge krav 6, hvor nævnte virus-vaccine vektor inkluderer nukleinsyresekvenser, der koder for et eller flere proteiner, der interfererer med pattedyrsværtscelle type I interferon (IFN)-responser valgt fra ikke-strukturelt protein 1 fra rotavirus, NSI protein fra influenzavirus, C12Rfra ectromliavirus, Ebola VP35, Vaccinia B18R, lymfocytisk choriomeningitisvirus (LCMV)-nukleoprotein, Hepatitis C-virus (HCV)-protease NS3/4A, E3L-protein af koppevirusser, sigma3-protein af reovirusser, USll-protein af herpes simplex-virus, og mus cytomegalovirus proteiner ml42 og ml43.
8. Den immunogene sammensætning ifølge krav 6, hvor nævnte virus-vaccine vektor udtrykker et eller flere virale, bakterielle eller parasitiske antigener fra nævnte et eller flere passager-gener.
9. Den immunogene sammensætning ifølge krav 6, hvor nævnte et eller flere passager-gener udtrykker et eller flere tuberkulose-antigener.
10. Den immunogene sammensætning ifølge krav 6, hvor nævnte et eller flere passager-gener udtrykker et eller flere malaria-antigener.
11. Den immunogene sammensætning ifølge krav 6, hvor nævnte et eller flere passager-gener udtrykker et eller flere HIV-antigener.
12. Den immunogene sammensætning ifølge krav 1, hvor nævnte pulverformulering har en median volumendiameter på 3,2-3,5 pm.
13. Fremgangsmåde til at danne en immunogen sammensætning, omfattende: at sprøjtetørre en eller flere levende virusser fra en sammensætning omfattende mannitol ved 50-100 mg/ml, cyclodextrin ved 0,2-1 mg/ml, trehalose ved 0,5-5 mg/ml, og dextran ved 0,5-5 mg/ml til at danne et sprøjtetørret pulver indeholdende nævnte ene eller flere levende virusser, hvor virussen er svækket virus egnet til anvendelse som en vaccine valgt fra poliovirus, rotavirus, orthomyxovirus inklusiv influenzavirusser, retrovirus inklusiv RSV, koppevirus, inklusiv vaccinia, parvovirus inklusiv adeno-associerede virusser, papilllomaviridae, inklusiv HPV, herpesvirus inklusiv EBV, CMV eller herpes simplex-virus, lentivirus.
14. Fremgangsmåden ifølge krav 13, hvor nævnte ene eller flere virusser inkluderer mindst en virus, der er en genetisk modificeret virus-vaccine vektor, der koder for et eller flere passager-gener, der er fremmede for nævnte genetisk modificerede virus-vaccine vektor, fortrinsvis hvor nævnte virus-vaccine er ikke-replikerende eller replikationsdefekt, i særdeleshed hvor nævnte virus-vaccine vektor er en adenovirus.
15. Fremgangsmåden ifølge krav 14, hvor nævnte virus-vaccine vektor udtrykker et eller flere virale, bakterielle eller parasitiske antigener fra nævnte ene eller flere passager-gener, i særdeleshed hvor nævnte ene eller flere passager-gener udtrykker et eller flere tuberkulose-antigener, malaria-antigener, eller HIV-antigener.
DK10778366.4T 2009-05-20 2010-05-20 Stabile, sprøjtetørrede, immunogene, virussammensætninger DK2432502T3 (da)

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US17974409P 2009-05-20 2009-05-20
PCT/US2010/035521 WO2010135495A2 (en) 2009-05-20 2010-05-20 Stable, spray dried, immunogenic, viral compositions

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EP (1) EP2432502B1 (da)
CN (2) CN102481356A (da)
DK (1) DK2432502T3 (da)
ES (1) ES2661215T3 (da)
PL (1) PL2432502T3 (da)
PT (1) PT2432502T (da)
TR (1) TR201802619T4 (da)
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EP2432502A4 (en) 2013-01-30
PL2432502T3 (pl) 2018-05-30
US20200397885A1 (en) 2020-12-24
EP2432502A2 (en) 2012-03-28
PT2432502T (pt) 2018-03-08
US20180161415A9 (en) 2018-06-14
WO2010135495A2 (en) 2010-11-25
US9610343B2 (en) 2017-04-04
CN105770882A (zh) 2016-07-20
US10736953B2 (en) 2020-08-11
US20230084215A1 (en) 2023-03-16
US20190328862A1 (en) 2019-10-31
US11446373B2 (en) 2022-09-20
CN102481356A (zh) 2012-05-30
ES2661215T3 (es) 2018-03-28
TR201802619T4 (tr) 2018-03-21
WO2010135495A3 (en) 2011-04-21
EP2432502B1 (en) 2018-01-03
US20180015158A1 (en) 2018-01-18
US20120058162A1 (en) 2012-03-08

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