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Title:Safety and efficacy of immunotherapy with the recombinant B-cell epitope-based grass pollen vaccine BM32
Authors:ID Niederberger, Verena (Author)
ID Neubauer, Angela (Author)
ID Gevaert, Philippe (Author)
ID Zidarn, Mihaela, Klinika Golnik (Author)
ID Worm, Margitta (Author)
ID Aberer, Werner (Author)
ID Malling, Hans Jørgen (Author)
ID Pfaar, Oliver (Author)
ID Klimek, Ludger (Author)
ID Pfützner, Wolfgang (Author)
Files:.pdf PDF - Presentation file, download (3,82 MB)
MD5: B3355AB81794714EF54891AAFA58F46D
 
URL URL - Source URL, visit https://www.sciencedirect.com/science/article/pii/S0091674917318845?via%3Dihub
 
Language:English
Typology:1.01 - Original Scientific Article
Organization:Logo UKPBAG - University Clinic of Respiratory and Allergic Diseases Golnik
Abstract:Background BM32 is a grass pollen allergy vaccine based on recombinant fusion proteins consisting of nonallergenic peptides from the IgE-binding sites of the 4 major grass pollen allergens and the hepatitis B preS protein. Objective We sought to study the safety and clinical efficacy of immunotherapy (allergen immunotherapy) with BM32 in patients with grass pollen-induced rhinitis and controlled asthma. Methods A double-blind, placebo-controlled, multicenter allergen immunotherapy field study was conducted for 2 grass pollen seasons. After a baseline season, subjects (n = 181) were randomized and received 3 preseasonal injections of either placebo (n = 58) or a low dose (80 [micro]g, n = 60) or high dose (160 [micro]g, n = 63) of BM32 in year 1, respectively, followed by a booster injection in autumn. In the second year, all actively treated subjects received 3 preseasonal injections of the BM32 low dose, and placebo-treated subjects continued with placebo. Clinical efficacy was assessed by using combined symptom medication scores, visual analog scales, Rhinoconjunctivitis Quality of Life Questionnaires, and asthma symptom scores. Adverse events were graded according to the European Academy of Allergy and Clinical Immunology. Allergen-specific antibodies were determined by using ELISA, ImmunoCAP, and ImmunoCAP ISAC. Results Although statistical significance regarding the primary end point was not reached, BM32-treated subjects, when compared with placebo-treated subjects, showed an improvement regarding symptom medication, visual analog scale, Rhinoconjunctivitis Quality of Life Questionnaire, and asthma symptom scores in both treatment years. This was accompanied by an induction of allergen-specific IgG without induction of allergen-specific IgE and a reduction in the seasonally induced increase in allergen-specific IgE levels in year 2. In the first year, more grade 2 reactions were observed in the active (n = 6) versus placebo (n = 1) groups, whereas there was almost no difference in the second year. Conclusions Injections of BM32 induced allergen-specific IgG, improved clinical symptoms of seasonal grass pollen allergy, and were well tolerated.
Keywords:allergy, allergen immunotherapy, B-cell epitope-based immunotherapy
Publication status:Published
Publication version:Version of Record
Place of publishing:ZDA
Publisher:Elsevier
Year of publishing:2018
Number of pages:str. 497-509
Numbering:Vol. 142, iss. 2
PID:20.500.12556/DiRROS-12919 New window
UDC:616-097
ISSN on article:0091-6749
DOI:10.1016/j.jaci.2017.09.052 New window
COBISS.SI-ID:33624793 New window
Copyright:© 2017 The Authors
Note:Soavtorji: Angela Neubauer, Philippe Gevaert, Mihaela Zidarn, Margitta Worm, Werner Aberer, Hans Jørgen Malling, Oliver Pfaar, Ludger Klimek, Wolfgang Pfützner, Johannes Ring, Ulf Darsow, Natalija Novak, Roy Gerth van Wijk, Julia Eckl-Dorna, Margarete Focke-Tejkl, Milena Weber, Hans-Helge Müller, Joachim Klinger, Frank Stolz, Nora Breit, Rainer Henning and Rudolf Valenta;
Publication date in DiRROS:17.12.2020
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Record is a part of a journal

Title:The Journal of allergy and clinical immunology
Shortened title:J Allergy Clin Immunol
Publisher:Elsevier
ISSN:0091-6749
COBISS.SI-ID:6324487 New window

Licences

License:CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Link:http://creativecommons.org/licenses/by-nc-nd/4.0/
Description:The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.
Licensing start date:17.01.2018

Secondary language

Language:Undetermined
Keywords:alergija, alergijska imunoterapija, imunoterapija na osnovi epitopov B celic


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