Allergen products for diagnosis and therapy: regulation and science: 13th International Paul-Ehrlich-Seminar, September 14 - 17, 2011, Hyatt Regency Washington on Capitol Hill, Washington DC, USA / ed. by K.Cichutek et al.; coed. L.Vogel, D.Bartel, R.Gutberlet; [Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines]. - Wiesbaden: Chmielorz, [2011]. - 203 p.: ill., graph. - (Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel; Bd.97). - Incl. bibl. ref. - ISBN 978-3-87124-370-7  Место хранения:   01 | ГПНТБ СО РАН | Новосибирск

Оглавление / Contents

Arbeiten aus dem Paul-Ehrlich-Institut Allergen Products for Diagnosis and Therapy: Regulation and Science Foreword Ronald L. Rabin, S. Vieths, Jay E. Slater .................... 1 Opening Keynote Address: History of Specific Immunotherapy Harold S. Nelson ............................................. 3 Session 1: Legal Aspects of the Regulation of Allergen Products Chairs: Stefan Vieths, Harold S. Nelson ...................... 7 Legal Status and Regulation of Allergenic Products in the United States Sandra Menzies, Susan Huynh, Ronald L. Rabin ................. 9 Regulation of Allergen Products in Europe (Including NPPs) Carlo Pini .................................................. 15 Current Status and Regulation of Allergen Products in Mexico Désirée Larenas Linnemann ................................... 23 Regulation of Allergen Products in Canada: An Overview of the Current and the Proposed Regulatory Frameworks Nancy Green ................................................. 27 Current and Future Challenges for the Allergen Manufacturers Lars Jacobsen ............................................... 31 Session 2: Standardization and Characterization of Natural Allergen Products Chairs: Fatima Ferreira, Marcel Hoefnagel ...................... 35 Update on the FDA/CBER Allergen Standardization Program Taruna Khurana, Jay E. Slater ............................... 37 Validation of Major Allergen References and ELISAs - Current State of the BSP090 Project Susanne Kaul, Oliver Dehus, Julia Zimmer, Stefan Vieths ..... 45 Molecular and Functional Characterization of Natural Allergen Extracts Thierry Batard, Emmanuel Nony, Henri Chabre, Maud Hrabina, Julien Bouley, Maxime Lemignon, Pierrick Lemoine, Karine Jain, Sophie Tourdot, Laurent Mascarell, Véronique Bodo, Philippe Moingeon ........................................... 54 The Potential of Mass Spectrometry as a Novel Tool in Standardization of Natural Allergen Extracts Peter Briza ................................................. 57 Session 3: Methods in Product and Study Design of Effective Allergen Products for Therapy Chairs: Stephen R. Durham, Fréderic de Blay .................... 63 Efficacy Testing of Allergen Mixtures for Specific Immunotherapy Jörg Kleine-Tebbe .............................................. 65 Biomarkers of Tolerance in Response to Allergen Immunotherapy Stephen R. Durham, Guy W. Scadding, Deborah Phippard, Peter A. Wurtzen, Mohamed H. Shamji ......................... 75 Multiplex IgE Antibody Testing As a Tool for Diagnosis and Defining the Allergic (Atopic) Status of Study Populations Robert G. Hamilton .......................................... 82 Environmental Exposure Units for Specific Immunotherapy Trials Anne K. Ellis ........................................ 91 Session 4: Standardization and Characterization of Modified and Recombinant Allergen Products Chairs: Jay E. Slater, Geoffrey A. Mueller .................. 95 Physicochemical Characterisation of Mite Allergoids and Alum-Adsorbed Mite Allergoids Dion Luykx, Jan Cordewener, Jurgen de Bruijn, Adrie Westphal, Hetty Sleijster, Twan America, Rob van den Hout ... 97 Physicochemical Characterization of Recombinant Allergens and Hypoallergenic Variants Martin Himly, Michael Wallner, Nadja Zaborsky, Michael Hauser, Gabriele Gadermeier, Andrea Harrer, Fátima Ferreira ................................................... 101 Antibody-Based Assays for Potency Determination of Mite Allergoids and for Stability Studies of Alum-Adsorbed Mite Vaccines Erica Kerkvliet, Niels Sinnige, Carola Franso, Ronald van Ree, Rob van den Hout ...................................... 106 Session 5: Immunological Mechanisms of Allergy Immunotherapy Chairs: Philippe Moingeon, Caiman Prussin ..................... 113 An Overview of Proposed Mechanisms of Specific Immunotherapy Thomas A. E. Platts-Mills ..................................... 115 Mechanisms of Immunotherapy Specific to the Sublingual or Oral Route Jean-Pierre Allam ............................................. 119 Oral Immunotherapy for Food Allergy Wesley Burks .................................................. 122 Interleukin-5+ Super-Effector Th2 Cells As Targets for Immunotherapy and Drug Discovery Caiman Prussin ................................................ 124 Use of Trichuris Suis Ova (TSO) Therapy for the Treatment of Allergy Peter Bager ................................................... 128 Session 6: Immunotherapy With Purified Allergen Components Chairs: Ronald van Ree, Barbara Bohle ......................... 131 Current Status of Subcutaneous and Sublingual Immunotherapy With Recombinant Allergens Marek Jutel, Katarzyna Solarewicz-Madejek, Sylwia Smolinska .................................................. 133 Recombinant Allergens for SIT of Mite Allergy Andreas Nandy, Martin Wald, Steffen Augustin, Linda Pump, Helga Kahlert, Gerald Reese, Gesine Cornelissen, Steen Klysner .............................................. 140 Recombinant Allergens for SIT of Cat Allergy Kåre Meno .................................................. 148 Targeting Antibody Receptors As an Approach Towards Immunotherapy Rachana Agrawal, Kathryn Hьlse, Judith A. Woodfolk ......... 153 Session 7: Extrinsic Adjuvants in the Use of Allergen Immunotherapy Chairs: Christopher L. Karp, Jörg Kleine-Tebbe ................ 157 Toll-Like Receptor Ligands As Adjuvants in Allergy Vaccines Stephan Deifl, Claudia Kitzmüller, Barbara Bohle ........... 159 Adjuvants and Vector Systems for the Sublingual Route Philippe Moingeon, Véronique Bodo, Sabi Airouche, Laurent Mascarell, Thierry Batard .................................. 164 Session 8: Immunomodulatory Properties of Allergens Chairs: Robert E. Esch, N. Franklin Adkinson ............... 169 Structural Studies of Allergens Suggest Hypotheses for Immune System Interactions Geoffrey A. Mueller ........................................ 171 Session 9: State-of-the-Art of Immunotherapy in Different Allergic Diseases Chairs: Marek Jutel, Ronald L. Rabin .......................... 175 Sublingual Immunotherapy: Overview of American Experience Paul A. Greenberger ........................................ 177 SLIT Clinical Trials for Allergic Rhinitis in the U.S. Robert E. Esch ............................................. 180 The Politics and Economics of Specific Immunotherapy Across Europe Anthony Frew ............................................... 182 SIT for the Treatment of Atopic Dermatitis Jean-Pierre Allam .......................................... 186 List of Contributors .......................................... 189 List of Participants .......................................... 190