DK2056871T3 - Proteinmatrixvacciner og fremgangsmåder til fremstilling og administration af sådanne vacciner - Google Patents

Proteinmatrixvacciner og fremgangsmåder til fremstilling og administration af sådanne vacciner Download PDF

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Publication number
DK2056871T3
DK2056871T3 DK07836580.6T DK07836580T DK2056871T3 DK 2056871 T3 DK2056871 T3 DK 2056871T3 DK 07836580 T DK07836580 T DK 07836580T DK 2056871 T3 DK2056871 T3 DK 2056871T3
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protein
antigen
carrier protein
polysaccharide
vaccines
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DK07836580.6T
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English (en)
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John J Mekalanos
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Harvard College
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/095Neisseria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/025Enterobacteriales, e.g. Enterobacter
    • A61K39/0275Salmonella
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/025Enterobacteriales, e.g. Enterobacter
    • A61K39/0283Shigella
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/07Bacillus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/09Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/09Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092Streptococcus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/116Polyvalent bacterial antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/385Haptens or antigens, bound to carriers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/64Medicinal preparations containing antigens or antibodies characterised by the architecture of the carrier-antigen complex, e.g. repetition of carrier-antigen units
    • A61K2039/645Dendrimers; Multiple antigen peptides
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Claims (12)

1. Fremgangsmåde til fremstilling af en vaccinesammensætning, som omfatter et antigen, der er indesluttet i bærerproteinmatrixen og er ikke-kovalent forbundet med proteinmatrixen, hvilken fremgangsmåde omfatter (i) blanding af et antigen af interesse valgt fra gruppen bestående af et polysaccharid, en polyalkohol, hvor polyalkoholen er en hydrogeneret form af et carbohydrat, hvor en carbonylgruppe er blevet reduceret til en primær eller sekundær hydroxygruppe, og en polyaminosyrehomopolymer med et bærerprotein, og (ii) tilsætning af en linker, som tværbinder bærerproteinet via sulfhydryl-, amino- eller carboxygrupper på bærerproteinmolekylerne, og (iii) tværbinding af bærerproteinet for at danne en bærerproteinmatrix.
2. Fremgangsmåde ifølge krav 1, hvor vaccinesammensætningen endvidere omfatter en farmaceutisk acceptabel excipiens.
3. Fremgangsmåde ifølge krav 1, hvor det molære forhold mellem antigenet og bærerproteinet er på mellem 1 til 10 og 10 til 1 i vaccinesammensætningen.
4. Fremgangsmåde ifølge krav 1, hvor bærerproteinet er en multimer, navnlig hvor multimeren omfatter mindst 5 subunits, eller hvor multimeren er en homomultimer.
5. Fremgangsmåde ifølge krav 1, hvor fremgangsmåden omfatter reduktion af en Schiff-base i bærerproteinet.
6. Fremgangsmåde ifølge krav 1, hvor bærerproteinet er kovalent tværbundet til mindst ét andet bærerprotein, navnlig hvor den kovalente tværbinding omfatter en peptidbinding mellem en primær aminogruppe i en lysinsidekæde og en carboxygruppe i en aspartat- eller glutamatsidekæde, eller hvor den kovalente binding omfatter en bifunktionel tværbinder, især hvor den bifunktionelle tværbinder er glutaraldehyd, bis[sulfosuccinimidyl]suberat eller dimethyladipimidat.
7. Fremgangsmåde ifølge krav 1, hvor linkeren er en forbindelse med formlen CHO r!-cho, hvor Rn er en lineær eller forgrenet alkylgruppe med 1 til 12 carbonatomer, en lineær eller forgrenet heteroalkylgruppe med 1 til 12 atomer, en lineær eller forgrenet alkengruppe med 2 til 12 carbonatomer, en lineær eller forgrenet alkyngruppe med 2 til 12 carbonatomer, en aromatisk rest med 5 til 10 carbonatomer, et cyklisk system med 3 til 10 atomer, (CH2CH2O) qCfhCER-, hvor q er 1 til 4, eller hvor linkeren er glutaraldehyd, m-maleimidobenzoyl-N-hydroxysuccinimidester, carbodiimid eller bis-diazoteret benzidin.
8. Fremgangsmåde ifølge krav 1, hvor bærerproteinet er difteritoksin eller en mutant deraf, difteritoksoid, tetanustoksin eller en mutant deraf, tetanustoksoid, Pseudomonas aeruginosa-eksotoksin A eller en mutant deraf, koleratoksin B-subunit, tetanustoksinfragment C, bakterielt flagellin, pneumolysin, listeriolysin O, et ydermembranprotein fra Neisseria meningitidis, Pseudomonas aeruginosa-Hcpl-protein, varmelabilt Escherichia coli-enterotoksin, shigalignende toksin, humant LTB-protein, en proteinekstrakt fra hele bakterieceller, den dominant negative mutant (DNI) af det beskyttende antigen fra Bacillus anthracis eller Escherichia coli-beta-galactosidase, navnlig hvor de hele bakterieceller er Pseudomonas aeruginosa- eller Streptococcus-celler, eller hvor det bakterielle flagellin er Vibrio cholerae-flagellinproteinet.
9. Fremgangsmåde ifølge krav 1, hvor det shigalignende toksin er Shigella-SltB2-proteinet.
10. Fremgangsmåde ifølge krav 1, hvor polysaccharidet omfatter mindst 18 rester, eller hvor polysaccharidet er et Streptococcus pneumoniae-polysaccharid, Francisella tularensis-polysaccharid, Bacillus anthracis-polysaccharid, Haemophilus influenzae-polysaccharid, Salmonella typhi-polysaccharid, Shigella-art-polysaccharider, Salmonella-art-polysaccharider eller Neisseria meningitidis-polysaccharid, især hvor Streptococcus pneumoniae-polysaccharidet er kapseltype 3, 4, 6B, 7A, 7B, 7C, 7F, 9A, 9L, 9N, 9V, 12A, 12B, 12F, 14, 15A, 15B, 15C, 15F, 17, 18B, 18C, 19F, 23F, 25A, 25F, 33F, 35, 37, 38, 44 eller 46, eller hvor Francisella tularensis-polysaccharidet er O-antigen.
11. Fremgangsmåde ifølge krav 1, hvor polyaminosyrehomopolymeren er en mikrobiel kapselpolymer, navnlig hvor den mikrobielle kapselpolymer er poly-gamma-D-glutaminsyre fra Bacillus anthracis.
12. Fremgangsmåde ifølge krav 1, som endvidere omfatter et andet antigen af interesse, og hvor fremgangsmåden navnlig endvidere omfatter et tredje antigen af interesse.
DK07836580.6T 2006-08-07 2007-08-07 Proteinmatrixvacciner og fremgangsmåder til fremstilling og administration af sådanne vacciner DK2056871T3 (da)

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US83594406P 2006-08-07 2006-08-07
US93376407P 2007-06-08 2007-06-08
PCT/US2007/017528 WO2008021076A2 (en) 2006-08-07 2007-08-07 Protein matrix vaccines and methods of making and administering such vaccines

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US (3) US8642042B2 (da)
EP (2) EP2056871B1 (da)
JP (2) JP5745221B2 (da)
KR (1) KR101446238B1 (da)
AU (1) AU2007284878B2 (da)
BR (1) BRPI0715396B8 (da)
CA (1) CA2660022C (da)
DK (1) DK2056871T3 (da)
ES (1) ES2658851T3 (da)
MX (1) MX2009001412A (da)
TW (1) TWI565713B (da)
WO (1) WO2008021076A2 (da)

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EP2056871A2 (en) 2009-05-13
MX2009001412A (es) 2009-04-24
BRPI0715396B8 (pt) 2021-05-25
US9216223B2 (en) 2015-12-22
US20080095803A1 (en) 2008-04-24
BRPI0715396B1 (pt) 2019-02-19
US20160136257A1 (en) 2016-05-19
KR20090066272A (ko) 2009-06-23
JP2014058530A (ja) 2014-04-03
ES2658851T3 (es) 2018-03-12
KR101446238B1 (ko) 2014-10-01
TWI565713B (zh) 2017-01-11
US8642042B2 (en) 2014-02-04
CA2660022A1 (en) 2008-02-21
CA2660022C (en) 2014-11-04
US9533032B2 (en) 2017-01-03
WO2008021076A3 (en) 2008-12-04
EP2056871B1 (en) 2017-11-15
EP2056871A4 (en) 2010-04-14
AU2007284878A1 (en) 2008-02-21
EP3260134A1 (en) 2017-12-27
BRPI0715396A2 (pt) 2013-11-26
WO2008021076A2 (en) 2008-02-21
JP2010500354A (ja) 2010-01-07
AU2007284878B2 (en) 2013-01-17
JP5745221B2 (ja) 2015-07-08
TW200823230A (en) 2008-06-01
US20140186399A1 (en) 2014-07-03

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