WO2010103022A3 - Oil-in-water adjuvanted influenza vaccine - Google Patents

Oil-in-water adjuvanted influenza vaccine Download PDF

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Publication number
WO2010103022A3
WO2010103022A3 PCT/EP2010/053004 EP2010053004W WO2010103022A3 WO 2010103022 A3 WO2010103022 A3 WO 2010103022A3 EP 2010053004 W EP2010053004 W EP 2010053004W WO 2010103022 A3 WO2010103022 A3 WO 2010103022A3
Authority
WO
WIPO (PCT)
Prior art keywords
oil
administration
water emulsion
influenza virus
virus strain
Prior art date
Application number
PCT/EP2010/053004
Other languages
French (fr)
Other versions
WO2010103022A2 (en
Inventor
Catherine Caillet
Fabienne Piras-Douce
Inca Carola Kusters
Original Assignee
Sanofi Pasteur
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Pasteur filed Critical Sanofi Pasteur
Publication of WO2010103022A2 publication Critical patent/WO2010103022A2/en
Publication of WO2010103022A3 publication Critical patent/WO2010103022A3/en

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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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/55566—Emulsions, e.g. Freund's adjuvant, MF59
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

The present invention is related to the use of a composition comprising at least one antigen derived from a H5 influenza virus strain, for the preparation of an influenza immunization composition for administration according to a regimen comprising at least a 1st and a 2nd administration steps timely separated, wherein the H5 influenza virus strain of the 1st administration step is different from the H5 influenza virus strain of the 2nd administration step and wherein the immunization composition used in at least one of the 1st or the 2 nd administration step comprises an oil-in-water emulsion as an adjuvant, wherein said oil-in-water emulsion comprises at least squalene, an aqueous solvent, a polyoxyethylene alkyl ether hydrophilic nonionic surfactant, a hydrophobic nonionic surfactant, and wherein said oil-in-water emulsion is obtainable by a phase inversion temperature process and wherein 90 % of the population by volume of the oil drops has a size less than 200 nm, and optionally less than 150 nm.
PCT/EP2010/053004 2009-03-12 2010-03-10 Oil-in-water adjuvanted influenza vaccine WO2010103022A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP09356018 2009-03-12
EP09356018.3 2009-03-12
US24173109P 2009-09-11 2009-09-11
US61/241,731 2009-09-11

Publications (2)

Publication Number Publication Date
WO2010103022A2 WO2010103022A2 (en) 2010-09-16
WO2010103022A3 true WO2010103022A3 (en) 2011-05-26

Family

ID=41198657

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/053004 WO2010103022A2 (en) 2009-03-12 2010-03-10 Oil-in-water adjuvanted influenza vaccine

Country Status (1)

Country Link
WO (1) WO2010103022A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105288614A (en) * 2014-06-18 2016-02-03 潘皓 Vaccine composition and its preparation method

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070014805A1 (en) * 2005-07-07 2007-01-18 Sanofi Pasteur Immuno-adjuvant emulsion
US20080014217A1 (en) * 2006-07-17 2008-01-17 Emmanuel Jules Hanon Influenza vaccine
WO2008056263A2 (en) * 2006-11-08 2008-05-15 Novartis Ag Quality control methods for oil-in-water emulsions containing squalene
WO2009068992A1 (en) * 2007-11-26 2009-06-04 Novartis Ag Vaccination with multiple clades of h5 influenza a virus

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1951299B1 (en) 2005-11-04 2012-01-04 Novartis Vaccines and Diagnostics S.r.l. Influenza vaccines including combinations of particulate adjuvants and immunopotentiators

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070014805A1 (en) * 2005-07-07 2007-01-18 Sanofi Pasteur Immuno-adjuvant emulsion
US20080014217A1 (en) * 2006-07-17 2008-01-17 Emmanuel Jules Hanon Influenza vaccine
WO2008056263A2 (en) * 2006-11-08 2008-05-15 Novartis Ag Quality control methods for oil-in-water emulsions containing squalene
WO2009068992A1 (en) * 2007-11-26 2009-06-04 Novartis Ag Vaccination with multiple clades of h5 influenza a virus

Non-Patent Citations (11)

* Cited by examiner, † Cited by third party
Title
BANZHOFF ANGELIKA ET AL: "MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults.", PLOS ONE 2009 LNKD- PUBMED:19197383, vol. 4, no. 2, E4384, 6 February 2009 (2009-02-06), pages 1 - 10, XP002627570, ISSN: 1932-6203 *
BARAS B ET AL: "A vaccine manufacturer's approach to address medical needs related to seasonal and pandemic influenza viruses", INFLUENZA AND OTHER RESPIRATORY VIRUSES, vol. 2, no. 6, 9 December 2008 (2008-12-09), pages 251 - 260, XP009115100, ISSN: 1750-2640, [retrieved on 20081209] *
BRESSON J L ET AL: "Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial", LANCET THE, LANCET LIMITED. LONDON, GB, vol. 367, no. 9523, 20 May 2006 (2006-05-20), pages 1657 - 1664, XP025094558, ISSN: 0140-6736, [retrieved on 20060520] *
IKENO D ET AL: "A prime-boost vaccination of mice with heterologous H5N1 strains", VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD, GB, vol. 27, no. 23, 18 May 2009 (2009-05-18), pages 3121 - 3125, XP026058730, ISSN: 0264-410X, [retrieved on 20090421] *
JONES TAFF: "GSK's novel split-virus adjuvanted vaccines for the prevention of the H5N1 strain of avian influenza infection", CURRENT OPINION IN MOLECULAR THERAPEUTICS, THOMSON REUTERS (SCIETIFIC) LTD, vol. 11, no. 3, 1 June 2009 (2009-06-01), pages 337 - 345, XP009125136, ISSN: 2040-3445 *
KEITEL ET AL: "Preparing for a possible pandemic: influenza A/H5N1 vaccine development", CURRENT OPINION IN PHARMACOLOGY, ELSEVIER SCIENCE PUBLISHERS, NL, vol. 7, no. 5, 1 October 2007 (2007-10-01), pages 484 - 490, XP022300861, ISSN: 1471-4892 *
LEVIE KARIN ET AL: "An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults.", THE JOURNAL OF INFECTIOUS DISEASES 1 SEP 2008, vol. 198, no. 5, 1 September 2008 (2008-09-01), pages 642 - 649, XP002553874, ISSN: 0022-1899 *
POLAND G A ET AL: "Vaccines against influenza A (H5N1): Evidence of progress", JOURNAL OF INFECTIOUS DISEASES 20080901 US, vol. 198, no. 5, 1 September 2008 (2008-09-01), pages 629 - 631, XP002553662, ISSN: 0022-1899 *
STEPHENSON I ET AL: "Boosting immunity to influenza H5N1 with MF59-adjuvanted H5N3 A/Duck/Singapore/97 vaccine in a primed human population", VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD, GB, vol. 21, no. 15, 2 April 2003 (2003-04-02), pages 1687 - 1693, XP004413557, ISSN: 0264-410X *
STEPHENSON IAIN ET AL: "Antigenically distinct MF59-adjuvanted vaccine to boost immunity to H5N1", 9 October 2008, NEW ENGLAND JOURNAL OF MEDICINE, MASSACHUSETTS MEDICAL SOCIETY, BOSTON, MA, US, PAGE(S) 1631 - 1633, ISSN: 1533-4406, XP002519289 *
STEPHENSON IAIN ET AL: "Cross-reactivity to highly pathogenic avian influenza H5N1 viruses after vaccination with nonadjuvanted and MF59-adjuvanted influenza A/duck/Singapore/97 (H5N3) vaccine: A potential priming strategy", JOURNAL OF INFECTIOUS DISEASES, UNIVERSITY OF CHICAGO PRESS, CHICAGO, IL, vol. 191, no. 8, 1 April 2005 (2005-04-01), pages 1210 - 1215, XP002421675, ISSN: 0022-1899 *

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Publication number Publication date
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