Arbeiten aus dem Paul-Ehrlich-Institut Regulatory Control and
Standardization of Allergenic Extracts
Foreword
Stefan Vieths, Johannes Löwer ................................... 1
Session I: Standardization and Characterization of Allergen
Products 1
Chairs: Stefan Vieths, Jay Slater ............................... 3
Allergen Source Materials: State-of-the-Art
Robert E. Esch ............................................... 5
BSP090 - The Follow-Up to CREATE
Florian Neske, Christian Schörner, Karl-Heinz Buchheit,
Angele Costanzo, Kay-Martin Hanschmann, Martin Himly,
Thomas Holzhauser, Fatima Ferreira, Susanne Kaul, Stefan
Vieths, Ronald van Ree ...................................... 12
Allergen Standardization: CREATE Principles Applied to Other
Purified Allergens
Martin D. Chapman, Stephanie Filep, Amy Tsay, Lisa D.
Vailes, Gabriele Gadermaier, Fatima Ferreira, Eva M. King ... 21
Round Table Discussion: Potency - Appropriate Assays,
Hypoallergenic Products
Stefan Vieths (chair), Robert E. Esch, Marcel Hoefnagel,
Lars Jacobsen, Bev Lees, Sandra Lopes ....................... 26
Session II: Standardization and Characterization of Allergen
Products 2
Chairs: Fatima Ferreira, Wolf-Meinhard Becker .................. 37
Physicochemical Characterization of Allergens: Quantity,
Identity, Purity, Aggregation and Conformation
Stef J. Koppelman, Dion M.A.M. Luykx, Harmen H.J. de
Jongh, Willem Jan Veldhuizen ................................ 39
Application of Proteomics for the Characterization of
Biological Allergen Extracts
Thierry Batard, Henri Chabre, Brigitte Gouyon, Emmanuel
Nony, Maud Hrabina, Karine Jain, Marie-Noelle Couret,
Virginie Brochier, Christian Beauvallet, Fook Tim Chew,
Philippe Moingeon ........................................... 55
Characterization of Allergoids
Martin Himly, Jerónimo Carnés, Enrique Fernández-Caldas,
Peter Briza, Fatima Ferreira ................................ 61
Antibody-based Methods for Standardization of Allergoids and
Recombinant Hypoallergens
Helmut Fiebig, Helga Kahlert, Bernhard Weber, Roland Suck,
Andreas Nandy, Oliver Cromwell .............................. 71
Session III: State-of-the-Art of Clinical Trials with
Therapeutic Allergen Products 2
Chairs: Roy Gerth van Wijk, Gabrielle Pauli .................... 85
Specific Immunotherapy by Different Allergen Applications:
Subcutaneous,Sublingual, Oral or Rectal Administration and
Lymph Node Injection
Jörg Kleine-Tebbe ........................................... 87
Primary and Secondary Endpoints in Clinical Trials
Lars Jacobsen ............................................... 96
State-of-the-Art Allergoids: Overview of Clinical Trials
Sabina Rak ................................................. 106
Potential Uses of NIR and IR Spectroscopy in Quality Control
of Allergy Vaccine Production
Yiwu Zheng, Xuxin Lai ...................................... 112
SQ-standardised Grass Tablet Sublingual Immunotherapy:
Persistent Clinical Benefit and Progressive Immunological
Changes During Three Years Treatment
Stephen R. Durham .......................................... 121
Session IV: News on Diagnostic Allergens
Chairs: Ronald van Ree, Adriano Mari .......................... 133
Diagnostic Reagents for Type I Allergy - What Criteria
Should Be Applied to Validation?
Uta Jappe .................................................. 135
Design of Clinical Trials With Patch Test Allergens in
the Netherlands
Thomas Rustemeyer .......................................... 147
Allergen Microarrays for Component-resolved Diagnosis
Marianne Brill ............................................. 151
The Importance of Molecular Allergens for in vitro Testing:
A Critical Evaluation of Component-resolved Diagnostics
Jonas Lidholm .............................................. 157
Session V: Legal Aspects of the Regulation of Allergen
Products 1
Chairs: Marcel Hoefnagel, Christian Schneider ................. 165
Responsibilities and New Challenges for EDQM and the OMCL
Network
Karl-Heinz Buchheit ........................................ 167
Introduction to CHMP Structures and Procedures
Christian K. Schneider ..................................... 172
A Global View of Allergenic Product Potency
Jay E. Slater .............................................. 178
New Regulatory Documents and Procedures I: Guideline on
Clinical Trials of SIT Products, European Pharmacopoeia,
and Note for Guidance on Allergen Products
Carlo Pini ................................................. 187
Regulation, Role and Future of Named Patient Products in
Germany
Sibylle May, Susanne Kaul, Dirk Lüttkopf, Stefan
Vieths ..................................................... 193
Session VI: Legal Aspects of the Regulation of Allergen
Products 2
Chairs: Carlo Pini, Karl-Heinz Buchheit ....................... 201
Regulatory Aspects of Clinical Trials in Children
Dirk Mentzer ............................................... 203
Patient-tailored Recombinant Allergen Products - Mission
Impossible?
Oliver Cromwell, Paolo M. Matricardi, Helmut Fiebig ........ 210
Regulation of Allergenic Products in the United States:
The Promise and Problem of Adjuvants in Allergen
Immunotherapy
Ronald L. Rabin ............................................ 219
Regulation of Allergen Products in Japan
Reiko Teshima .............................................. 224
Session VII: Mechanisms of Immunotherapy Revisited
Chairs: Andrew Saxon, Joachim Saloga .......................... 231
Cellular Responses, Serological Changes, or Both: What Are
They Good For?
Anthony J. Frew ............................................ 233
Different Immunotherapy Applications - Different Mechanisms?
SLIT versus SCIT - Differences in the Mode of Action
Jean-Pierre Allam, Thomas Bieber, Natalija Novak ........... 237
Session VIII: Immunotherapy with Recombinant Allergens
Chairs: Andrew Saxon, Joachim Saloga .......................... 247
Protein Families: Implications for Allergen Nomenclature,
Standardisation and Specific Immunotherapy
Heimo Breiteneder .......................................... 249
Clinical Trials With Recombinant Allergens: Research
Studies?
Gabrielle Pauli ............................................ 257
Clinical Trials With Recombinant Allergens - a Regulatory
Perspective
André F.A. Elferink ........................................ 266
Clinical Trials with Recombinant Allergens - Three
Perspectives: Industry
Annemie Narkus, Frans Kniest, Anja Menzel, Hanns Meyer,
Viola Sprung ............................................... 270
Session IX: Specific Immunotherapy - New Concepts 1
Chairs: Jörg Kleine-Tebbe, Henrik Jacobi ...................... 279
Prophylactic Allergen Vaccination: Current and Future
Perspectives
Patrick G. Holt ............................................ 281
Compliance and Convenience to Immunotherapy
Jean Bousquet, Pascal Demoly ............................... 289
Toll-like Receptors as Targets for Enhancing the Efficacy of
Immunotherapy
Sonja Mutschlechner, Stephan Deifl, Barbara Bohle .......... 296
Treatment With a Combination of anti-IgE and Specific
Immunotherapy for Allergic Rhinitis and Asthma
Eckard Hamelmann, Claudia Rolinck-Werninghaus, Ulrich
Wahn, Matthias Volkmar Kopp ................................ 303
Session X: Specific Immunotherapy - New Concepts 2
Chairs: Anthony Frew, Patrick Holt ............................ 317
IVN201 - Therapy With a Construct Containing Functional
Fusion Peptides
Horst Rose ................................................. 319
Sublingual Immunotherapy for Food Allergy
Ernesto Enrique ............................................ 329
A Novel Multi-potential Dendritic Cell Targeted Gene
Vaccination Platform; Application to Food Allergy and Beyond
Ke Zhang, Anne Behnecke, Wei Li, Andrew Saxon .............. 338
Allergy Vaccination With Peptides - SIT With Major Cat
Allergen Fel d 1 Peptides: Safety, Tolerability and Dose
Responses
Margitta Worm .............................................. 349
Closing Remarks
Stefan Vieths .............................................. 355
List of Contributors .......................................... 360
List of Participants .......................................... 361
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