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Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32

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 immunother...

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Autores principales: Niederberger, Verena, Neubauer, Angela, Gevaert, Philippe, Zidarn, Mihaela, Worm, Margitta, Aberer, Werner, Malling, Hans Jørgen, Pfaar, Oliver, Klimek, Ludger, Pfützner, Wolfgang, Ring, Johannes, Darsow, Ulf, Novak, Natalija, van Wijk, Roy Gerth, Eckl-Dorna, Julia, Focke-Tejkl, Margarete, Weber, Milena, Müller, Hans-Helge, Klinger, Joachim, Stolz, Frank, Breit, Nora, Henning, Rainer, Valenta, Rudolf
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6392176/
https://www.ncbi.nlm.nih.gov/pubmed/29361332
http://dx.doi.org/10.1016/j.jaci.2017.09.052
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author Niederberger, Verena
Neubauer, Angela
Gevaert, Philippe
Zidarn, Mihaela
Worm, Margitta
Aberer, Werner
Malling, Hans Jørgen
Pfaar, Oliver
Klimek, Ludger
Pfützner, Wolfgang
Ring, Johannes
Darsow, Ulf
Novak, Natalija
van Wijk, Roy Gerth
Eckl-Dorna, Julia
Focke-Tejkl, Margarete
Weber, Milena
Müller, Hans-Helge
Klinger, Joachim
Stolz, Frank
Breit, Nora
Henning, Rainer
Valenta, Rudolf
author_facet Niederberger, Verena
Neubauer, Angela
Gevaert, Philippe
Zidarn, Mihaela
Worm, Margitta
Aberer, Werner
Malling, Hans Jørgen
Pfaar, Oliver
Klimek, Ludger
Pfützner, Wolfgang
Ring, Johannes
Darsow, Ulf
Novak, Natalija
van Wijk, Roy Gerth
Eckl-Dorna, Julia
Focke-Tejkl, Margarete
Weber, Milena
Müller, Hans-Helge
Klinger, Joachim
Stolz, Frank
Breit, Nora
Henning, Rainer
Valenta, Rudolf
author_sort Niederberger, Verena
collection PubMed
description 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 μg, n = 60) or high dose (160 μg, 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.
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spelling pubmed-63921762019-02-27 Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32 Niederberger, Verena Neubauer, Angela Gevaert, Philippe Zidarn, Mihaela Worm, Margitta Aberer, Werner Malling, Hans Jørgen Pfaar, Oliver Klimek, Ludger Pfützner, Wolfgang Ring, Johannes Darsow, Ulf Novak, Natalija van Wijk, Roy Gerth Eckl-Dorna, Julia Focke-Tejkl, Margarete Weber, Milena Müller, Hans-Helge Klinger, Joachim Stolz, Frank Breit, Nora Henning, Rainer Valenta, Rudolf J Allergy Clin Immunol Article 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 μg, n = 60) or high dose (160 μg, 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. 2018-01-17 2018-08 /pmc/articles/PMC6392176/ /pubmed/29361332 http://dx.doi.org/10.1016/j.jaci.2017.09.052 Text en http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Niederberger, Verena
Neubauer, Angela
Gevaert, Philippe
Zidarn, Mihaela
Worm, Margitta
Aberer, Werner
Malling, Hans Jørgen
Pfaar, Oliver
Klimek, Ludger
Pfützner, Wolfgang
Ring, Johannes
Darsow, Ulf
Novak, Natalija
van Wijk, Roy Gerth
Eckl-Dorna, Julia
Focke-Tejkl, Margarete
Weber, Milena
Müller, Hans-Helge
Klinger, Joachim
Stolz, Frank
Breit, Nora
Henning, Rainer
Valenta, Rudolf
Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32
title Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32
title_full Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32
title_fullStr Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32
title_full_unstemmed Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32
title_short Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32
title_sort safety and efficacy of immunotherapy with the recombinant b-cell epitope–based grass pollen vaccine bm32
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6392176/
https://www.ncbi.nlm.nih.gov/pubmed/29361332
http://dx.doi.org/10.1016/j.jaci.2017.09.052
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