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Rabies Vaccine Tollwut-Impfstoff Vaccin Antirabique

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Rabies Vaccine Tollwut-Impfstoff Vaccin Antirabique (19) & (11) EP 1 593 392 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 39/205 (2006.01) A61K 39/42 (2006.01) 28.09.2011 Bulletin 2011/39 C07K 16/10 (2006.01) (21) Application number: 04023168.0 (22) Date of filing: 29.09.2004 (54) Rabies vaccine Tollwut-Impfstoff Vaccin antirabique (84) Designated Contracting States: • LODMELL D L ET AL: "Post-exposure DNA AT BE BG CH CY CZ DE DK EE ES FI FR GB GR vaccination protects mice against rabies virus" HU IE IT LI LU MC NL PL PT RO SE SI SK TR VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD,GB, vol. 19, no. 17-19, 21 March 2001 (30) Priority: 07.05.2004 US 569172 P (2001-03-21), pages 2468-2473, XP004231067 ISSN: 0264-410X (43) Date of publication of application: • SHIMAZAKI Y ET AL: "Immune response to 09.11.2005 Bulletin 2005/45 Japanese rabies vaccine in domestic dogs." JOURNAL OF VETERINARY MEDICINE SERIES (73) Proprietor: Novartis Vaccines and Diagnostics B, vol. 50, no. 2, March 2003 (2003-03), pages GmbH 95-98, XP002306648 ISSN: 0931-1793 35041 Marburg (DE) • ROOIJAKKERS E J M ET AL: "Potency of veterinary rabies vaccines in the Netherlands: A (72) Inventors: case for continued vigilance" VETERINARY • Banzhoff, Angelika, Dr. QUARTERLY, vol. 18, no. 4, 1996, pages 146-150, 35039 Marburg (DE) XP008038725 ISSN: 0165-2176 • Malerczyk, Claudius, Dr. • LODMELL D L ET AL: "Rabies cell culture 35039 Marburg (DE) vaccines reconstituted and stored at 4<o>C for 1 year prior to use protect mice against rabies (74) Representative: UEXKÜLL & STOLBERG virus" VACCINE, BUTTERWORTH SCIENTIFIC. Patentanwälte GUILDFORD, GB, vol. 22, no. 25-26, 3 September Beselerstrasse 4 2004 (2004-09-03), pages 3237-3239, 22607 Hamburg (DE) XP004526895 ISSN: 0264-410X • ANONYMOUS: INTERNET ARTICLE, [Online] (56) References cited: November 1996 (1996-11), XP002306650 WO-A-02/078732 Retrieved from the Internet: URL:http: //www.vetpharm.unizh.ch/TAK/00000 • BISWAS SUBHABRATA ET AL: "Preexposure 000/00001404.VAK> [retrieved on 2004-11] efficacy of a novel combination DNA and • BARTH R ET AL: "NIH TEST A PROBLEMATIC inactivated rabies virus vaccine" HUMAN GENE METHOD FOR TESTING POTENCY OF THERAPY, vol. 12, no. 15, 10 October 2001 INACTIVATED RABIES VACCINE" VACCINE, vol. (2001-10-10), pages 1917-1922, XP002306647 6, no. 4, 1988, pages 369-377, XP002306651 ISSN: ISSN: 1043-0342 0264-410X • WARRELL M J ET AL: "Rabies and other lyssavirus diseases." LANCET. 20 MAR 2004, vol. 363, no. 9413, 20 March 2004 (2004-03-20), pages 959-969, XP004497225 ISSN: 1474-547X Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 1 593 392 B1 Printed by Jouve, 75001 PARIS (FR) (Cont. next page) EP 1 593 392 B1 • ANONYMOUS: "Intradermal application of rabies • BRIGGS D J ET AL: "Antibody response of vaccines" REPORT OF A WHO CONSULTATION, patients after postexposure rabies vaccination [Online] 2000, XP002306653 Retrieved from the with small intradermal doses of purified chick Internet: URL:http://www.who.int/emc- embryo cell vaccine or purified Vero cell rabies documents/rabie s/docs/ vaccine" BULLETIN OF THE WORLD HEALTH whocdscsraph2005.pdf> [retrieved on 2004-11] ORGANIZATION, vol. 78, no. 5, 2000, pages • MADHUSUDANA S N ET AL: "Simulated post- 693-698, XP008038719 ISSN: 0042-9686 exposure rabies vaccination with purified chick • "IMOVAX Rabies"[Online] April 2000 (2000-04), embryo cell vaccine using a modified Thai Red XP002306655 Retrieved from the Internet: URL: Cross regimen." INTERNATIONAL JOURNAL OF http://www.aventispasteur.ca/avp_conte nt/ INFECTIOUS DISEASES : IJID : OFFICIAL docs/ca_products/IMOVAX_E.pdf> [retrieved on PUBLICATION OF THE INTERNATIONAL 2004-11] SOCIETY FOR INFECTIOUS DISEASES. MAY • JENKINSET AL.: "Compendium of Animal Rabies 2004, vol. 8, no. 3, May 2004 (2004-05), pages Prevention and Control, 2003" INTERNET 175-179, XP002306654 ISSN: 1201-9712 -& ARTICLE, [Online] 2004, XP002306656 Retrieved MADHUSUDANA S N: "Simulated post- exposure from the Internet: URL:http://www.avma.org/ rabies vaccination: authors’ response to Wilde et pubhlth/rabcont.as p> [retrieved on 2004-11] al" INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, INTERNATIONAL SOCIETY FOR INFECTIOUS DISEASES, HAMILTON, CA, vol. 8, no. 6, November 2004 (2004-11), page 376, XP004604576 ISSN: 1201-9712 -& WILDE H ET AL: "Simulated post-exposure rabies vaccination: comments on article by Madhusudana et al" INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, INTERNATIONAL SOCIETY FOR INFECTIOUS DISEASES, HAMILTON, CA, vol. 8, no. 6, November 2004 (2004-11) 2 1 EP 1 593 392 B1 2 Description BRIEF SUMMARY OF THE INVENTION [0001] The invention provides for an immunogenic ra- [0004] Applicants have surprisingly discovered that bies vaccine comprising a reduced vaccine dose and sufficient neutralizing antibody titers can be achieved by methods of post-exposure immunization with a reduced 5 immunization with a substantially reduced rabies virus dose. The concentration of rabies vaccine antigen per vaccine antigen concentration. In particular, rabies virus dose is less than 2.5 IU/mL. For example, the concen- vaccine antigen concentrations of substantially less than tration of rabies vaccine antigen may be less than half, the current WHO recommended 2.5 IU/mL can provide less than one fourth, or less than one eighth of 2.5 IU/mL. neutralizing antibody titers similar to those generated Preferably, the concentration of rabies vaccine antigen 10 with the standard dose. is between 2.4 IU/mL and 0.25 IU/mL, more preferably [0005] The invention provides for a composition com- between 2.0 IU/mL and 1.0 IU/mL and even more pref- prising a rabies virus vaccine, wherein the concentration erably between 1.75 IU/mL and 1.25 IU/mL, wherein 1.5 of the rabies virus vaccine antigen is less than 2.5 IU/mL. IU/mL is most preferred. This means, the concentration For example, the concentration of the vaccine antigen of the rabies virus vaccine antigen in the composition can 15 may be less than half, less than one fourth, or less than be 2.2 IU/mL, 1.8 IU/mL, 1.6 IU/mL, 1.4 IU/mL, 1.2 IU/mL, one eighth of 2.5 IU/mL. In other words, the concentration 0.8 IU/mL, 0.6 IU/mL, 0.4 IU/mL, 0.3 IU/mL, or 0.25 of the rabies virus vaccine antigen in the composition is IU/mL. The composition is a single-dose unit having a preferably less than 1.25 IU/mL, more preferably less volume of 0.1 mL, the vaccines of the invention are ad- than 0.625 IU/mL, and even more preferably less than ministered intradermally as part of a Thai Red Cross20 0.3125 IU/mL. Preferably, the concentration of rabies (TRD) or the modified Thai Red Cross regimen. vaccine antigen is between 2.4 IU/mL and 0.25 IU/mL, more preferably between 2.0 IU/mL and 1.0 IU/mL and BRIEF DESCRIPTION OF THE FIGURES even more preferably between 1.75 IU/mL and 1.25 IU/mL, wherein 1.5 IU/mL is most preferred. Preferably, [0002] 25 the composition is a single-dose unit having a volume of 0.1 mL. This means, the concentration of the rabies virus Figure 1 shows a schematic depiction of the post- vaccine antigen in the composition can be 2.2 IU/mL, 1.8 exposure 2-site intradermal regimen (also known as IU/mL, 1.6 IU/mL, 1.4 IU/mL, 1.2 IU/mL, 0.8 IU/mL, 0.6 Thai Red Cross Regimen). Doses of 0.1 mL PCECV IU/mL, 0.4 IU/mL, 0.3 IU/mL, or 0.25 IU/mL. Preferably, are administered intradermally at two different sites 30 the rabies virus vaccine is produced in a continuous cell of the patient’s body. Optionally, rabies immunoglob- line such as a purified chicken embryo cell line, a purified ulin can be given together with the first vaccine dose. vero cell line, or a human diploid cell line. Processes and means for the production of rabies antigen which make BACKGROUND OF THE INVENTION use of these cell lines are described, for example, in "Vac- 35 cines", Plotkin and Orenstein (eds.), 2004, Chapter 37, [0003] Despite the availability of modern cell culture "Rabies Vaccine", by Plotkin, Rupprecht, Koprowski. rabies vaccines, human rabies deaths continue to occur [0006] The vaccines of the invention are given thera- in developing countries where canine rabies is endemic peutically as part of a complete post exposure regimen and the cost of post- exposure prophylaxis is unaffordable and include administration intradermally. for the majority of the population. Current WHO recom- 40 mendations recommend a concentration of rabies virus DETAILED DESCRIPTION OF THE INVENTION vaccine derived from cell culture vaccines of at least 2.5 IU/mL. To overcome the financial burden, the WHO has [0007] The practice of the present invention will em- recommended two intradermal (ID) post- exposure rabies ploy, unless otherwise indicated, conventional methods treatment regimens that have been successfully imple- 45 of chemistry, biochemistry, molecular biology, immunol- mented in several countries (cf. WHO recommendations ogy and pharmacology, within the skill of the art. Such on Rabies Post-Exposure Treatment and the Correct techniques are explained fully in the literature. See, e.g., Technique of Intradermal Immunization against Rabies Remington’s Pharmaceutical Sciences, Mack Publishing [WHO/ECM/ZOO/96.6], WHO Doc 1996.).
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