SI9720050B - Multivalent dtp-polio vaccines - Google Patents

Multivalent dtp-polio vaccines Download PDF

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SI9720050B
SI9720050B SI9720050A SI9720050A SI9720050B SI 9720050 B SI9720050 B SI 9720050B SI 9720050 A SI9720050 A SI 9720050A SI 9720050 A SI9720050 A SI 9720050A SI 9720050 B SI9720050 B SI 9720050B
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immunogenic composition
composition according
toxoid
type
poliovirus
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SI9720050A
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SI9720050A (sl
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Raafat E F Fahim
Larry U L Tan
Luis Barreto
John Thipphawong
Gail E D Jackson
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Connaught Lab
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Priority claimed from US08/672,530 external-priority patent/US6696065B1/en
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Publication of SI9720050A publication Critical patent/SI9720050A/sl
Publication of SI9720050B publication Critical patent/SI9720050B/sl

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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/0016—Combination vaccines based on diphtheria-tetanus-pertussis
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/05—Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K39/099—Bordetella
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
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    • A61K39/102—Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A—HUMAN NECESSITIES
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    • 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
    • A61P31/12—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
    • A61P31/16—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
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    • 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
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • 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
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    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2770/00011—Details
    • C12N2770/32011—Picornaviridae
    • C12N2770/32611—Poliovirus
    • C12N2770/32634—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • 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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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Claims (22)

  1. Patentni zahtevki 1. Multivalentni imunogenski sestavek za dajanje zaščite v gostitelju proti bolezni, povzročeni z infekcijo z Bordetella pertussis, Clostridium tetani, Corynebacterium diphtheriae in poliovirusom, ki obsega: (a) pertusisni toksoid, filamentni hemaglutinin, pertaktin in aglutinogene v očiščeni obliki, (b) tetanusni toksoid, (c) difterični toksoid in (d) inaktiviran poliovirus, ki je formuliran kot vakcina za in vivo dajane gostitelju, označen s tem, da so posamezne komponente sestavka formulirane tako, da imunogenost posameznih komponent ni poslabšana z ostalimi posameznimi komponentami sestavka.
  2. 2. Imunogenski sestavek po zahtevku 1, označen s tem, da je nadalje okarakteriziran z adjuvansom.
  3. 3. Imunogenski sestavek po zahtevku 2, označen s tem, daje adjuvans aluminijev hidroksid ali aluminijev fosfat.
  4. 4. Imunogenski sestavek po zahtevku kateremkoli od zahtevkov 1 do 3, označen s tem, da je v posamezni humani dozi navedeni pertusisni toksoid prisoten v količini od 5 do 30 pg dušika, je navedeni filamentni hemaglutinin prisoten v količini od 5 do 30 pg dušika, je navedeni pertaktin prisoten v količini od 3 do 15 pg dušika in so navedeni aglutinogeni prisotni v količini od 1 do 10 pg dušika.
  5. 5. Imunogenski sestavek po zahtevku 4, označen s tem, da v posamezni humani dozi vsebuje 20 pg dušika pertusisnega toksoida, 20 pg dušika filamentnega hemaglutinina, 5 pg dušika pertaktina in 3 pg dušika aglutinogenov.
  6. 6. Imunogenski sestavek po kateremkoli od zahtevkov 1 do 5, označen s tem, daje navedeni difterični toksoid prisoten v količini od 10 do 20 Lfs in je navedeni tetanusni toksoid prisoten v količini od 1 do 10 Lfs.
  7. 7. Imunogenski sestavek po zahtevku 6, označen s tem, da je navedeni difterični toksoid prisoten v količini 15 Lfs in je tetanusni toksoid prisoten v količini 5 Lfs.
  8. 8. Imunogenski sestavek po kateremkoli od zahtevkov 1 do 7, označen s tem, da navedeni inaktivirani poliovirus obsega zmes inaktiviranih poliovirusov tipov 1, 2 in 3.
  9. 9. Imunogenski sestavek po zahtevku 8, označen s tem, da je navedena zmes inaktiviranih poliovirusov tipov 1, 2 in 3 prisotna v razmerjih: 20 do 50 D antigenskih enot poliovirusa tipa 1, 5 do 10 D antigenskih enot poliovirusa tipa 2, 20 do 50 D antigenskih enot poliovirusa tipa 3, v posamezni humani dozi.
  10. 10. Imunogenski sestavek po zahtevku 9, označen s tem, da uporabimo navedeno zmes inaktiviranih poliovirusov tipov 1, 2 in 3 v razmerjih: 40 D antigenskih enot poliovirusa tipa 1, 8 D antigenskih enot poliovirusa tipa 2, 32 D antigenskih enot poliovirusa tipa 3, v posamezni humani dozi.
  11. 11. Imunogenski sestavek po kateremkoli od zahtevkov 1 do 10, označen s tem, da nadalje daje zaščito proti bolezni, povzročeni z infekcijo s Haemophilus influenzae, in nadalje obsega konjugat nosilne molekule, izbrane iz skupine, ki sestoji iz tetanusnega toksoida in difteričnega toksoida, in kapsulamega polisaharida Haemophilus influenzae tipa b. 3 o r> 9 f> rt η > r> ι> -J ·.» Λ } O ·.) »
  12. 12. Imunogenski sestavek po zahtevku 11, označen s tem, da navedeni konjugat obsega konjugat tetanusnega toksoida ali difteričnega toksoida in poliriboza ribitol fosfata (PRP) Haemophilus influenzae tipa b.
  13. 13. Imunogenski sestavek po zahtevku llali 12, označen s tem, da je navedeni konjugat pripravljen v liofilizirani obliki in je rekonstituiran za dajanje v navedenem imunogenskem sestavku s komponentami sestavka.
  14. 14. Imunogenski sestavek po kateremkoli od zahtevkov 11 do 13, označen s tem, da navedeni imunogenski sestavek vsebuje v posamezni humani dozi konjugat v količini 5 do 15 μg PRP, konjugiranega na 15 do 35 pg tetanusnega toksoida.
  15. 15. Imunogenski sestavek po zahtevku 14, označen s tem, da navedeni imunogenski sestavek vsebuje v posamezni humani dozi konjugat v količini 10 pg PRP, konjugiranega na 20 pg tetanusnega toksoida.
  16. 16. Multivalentni vakcinski sestavek, označen s tem, da na 0,5 ml doze obsega 20 pg pertusisnega toksoida 20 pg filamentnega hemaglutinina 5 pg fimbrij 2 in 3 3 pg p ertaktina membranskega proteina 15 Lf difteričnega toksoida 5 Lf tetanusnega toksoida poliovirus tipa 1 40 D antigenskih enot poliovirus tipa 2 8 D antigenskih enot 1,5 pg aluminijevega fosfata.
  17. 17. Sestavek po zahtevku 16, označen s tem, da nadalje na 0,5 ml doze obsega 10 pg očiščenega poliriboza ribitol fosfat kapsulamega polisaharida (PRP) Haemophilus influenzae tipa b, kovalentno vezanega na 20 pg tetanusnega toksoida. 90 »o * ·) > μ ,*> O 0^0 © rt O > j =>o?> > <3 tV> 3 1 -Ί ·> Λ ,1 ·> O ·.» 1 O > > . j ,, m Λ ·> O ·> -·> O "1 > M 1 Λ 'J O 4
  18. 18. Sestavek po zahtevku 16 ali 17, označen s tem, da nadalje na 0,5 ml doze obsega 0,6 % 2-fenoksietanola.
  19. 19. Multivalentni imunogenski sestavek za dajanje zaščite v gostitelju proti bolezni, povzročeni z infekcijo z Bordetellla pertussis, Clostridium tetani, Corynebacterium diphtheriae in Haemophilus influenzae, ki obsega: (a) pertusisni toksoid, filamentni hemaglutinin, pertaktin in aglutinogene v očiščeni obliki, (b) tetanusni toksoid, (c) difterični toksoid in (d) konjugat nosilne molekule in kapsulamega polisaharida Haemophilus influenzae tipa b, ki je formuliran kot vakcina za in vivo dajanje gostitelju, označen s tem, da so posamezne komponente sestavka formulirane tako, da imunogenost posameznih komponent ni poslabšana z ostalimi posameznimi komponentami sestavka.
  20. 20. Imunogenski sestavek po zahtevku 19, označen s tem, da je navedena nosilna molekula izbrana izmed tetanusnega toksoida in difteričnega toksoida.
  21. 21. Mulitvalentni imunogenski sestavek po kateremkoli od zahtevkov 1-18 za imunizacijo gostitelja proti bolezni, povzočeni z Bordetella pertussis, Clostridium tetani, Corynebacterium diphtheriae in poliovirusom.
  22. 22. Mulitvalentni imunogenski sestavek po kateremkoli od zahtevkov 19-20 za imunizacijo gostitelja proti bolezni, povzočeni z Bordetellla pertussis, Clostridium tetani, Corynebacterium diphtheriae in Haemophilus influenzae.
SI9720050A 1996-07-02 1997-07-02 Multivalent dtp-polio vaccines SI9720050B (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/672,530 US6696065B1 (en) 1995-05-04 1996-07-02 Acellular pertussis vaccines and methods of preparation thereof
PCT/CA1997/000472 WO1998000167A1 (en) 1996-07-02 1997-07-02 Multivalent dtp-polio vaccines

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SI9720050A SI9720050A (sl) 1999-12-31
SI9720050B true SI9720050B (en) 2001-12-31

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EP (2) EP0914153B8 (sl)
JP (4) JP3280675B2 (sl)
CN (2) CN101310769B (sl)
AT (1) ATE339965T1 (sl)
AU (1) AU714493B2 (sl)
BR (2) BR9710460A (sl)
CA (1) CA2259415A1 (sl)
DE (1) DE69736709T2 (sl)
DK (1) DK0914153T3 (sl)
ES (1) ES2271969T3 (sl)
IL (1) IL127847A (sl)
NZ (1) NZ333989A (sl)
PL (1) PL187935B1 (sl)
PT (1) PT914153E (sl)
RO (1) RO120819B1 (sl)
RU (1) RU2194531C2 (sl)
SI (1) SI9720050B (sl)
SK (1) SK283565B6 (sl)
TR (1) TR199802783T2 (sl)
WO (1) WO1998000167A1 (sl)

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