Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32 - 04/08/18
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 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.
Le texte complet de cet article est disponible en PDF.Key words : Allergy, grass pollen allergy, allergen, allergen immunotherapy, recombinant allergen, B-cell epitope–based immunotherapy, efficacy, hypoallergenic, clinical trial, safety
Abbreviations used : AE, AIT, API, AR/C, EAACI, FAS, GPS, HBV, IDMC, LS, MS, RQLQ, SA, SMS, SPT, SS, VAS
Plan
| Supported by Biomay AG, Vienna, Austria, and research grants F4605 and F4613 of the Austrian Science Fund (FWF). R.V. is recipient of a Megagrant of the Government of the Russian Federation, grant number 14.W03.31.0024. |
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| Disclosure of potential conflict of interest: A. Neubauer is employed by Biomay and is a minor stockholder. W. Aberer has received travel support from Biomay AG. O. Pfaar's institution received grant funds from Biomay, and he has received consultant fees from HAL-Allergy Holding B.V./HAL-Allergie GmbH, Allergy Therapeutics/Bencard Allergie GmbH, Novartis Pharma, Laboratorios LETI/LETI Pharma, MEDA Pharma, ALK-Abelló, Anergis S.A., Biotech Tools S.A., Sanofi US Services, Mobile Chamber Experts (a GA2LEN partner), Pohl-Boskamp, Stallergenes-Greer, Lofarma, and Allergopharma; he has received grants from Stallergenes-Greer, HAL-Allergy Holding B.V./HAL-Allergie, Allergy Therapeutics/Bencard Allergie GmbH, Laboratorios LETI/LETI Pharma, and Anergis S.A.; his institution has received funds from these along with ALK-Abelló, Allergopharma, Lofarma, Nuvo, Circassia, and Biotech Tools S.A.; he has received lecture fees from HAL-Allergy Holding B.V./HAL-Allergie GmbH, Allergy Therapeutics/Bencard Allergie GmbH, Novartis Pharma, Laboratorios LETI/LETI Pharma, ALK-Abelló, Allergopharma, Lofarma, and Stallergenes-Greer; and he has received payment for educational presentations from Stallergenes-Greer. L. Klimek's institution has received consultant fees from ALK-Abelló, Allergopharma, Bionorica, Boehringer Ingelheim, Lofarma, Novartis, MEDA Pharma, and GlaxoSmithKline; has grants with ALK-Abelló, Allergopharma, Bencard, Biomay, HAL, GlaxoSmithKline, LETI, Lofarma, Novartis, and Roxall; has received fees for lectures from ALK-Abelló, Allergopharma, Bionorica, Boehringer, GlaxoSmithKline, Lofarma, Novartis, and MEDA Pharma; receives fees for manuscript preparation from MEDA Pharma and Bionorica; and receives fees for Board membership from MEDA Pharma and Novartis. W. Pfützner and his institution have received clinical study fees from Biomay. He has received consultant fees from ALK-Abelló and lecture fees from ALK-Abelló and Novartis and has grants from ALK-Abelló and Biomay. U. Darsow's institution has received funds as clinical study compensation. N. Novak's institution contributed study patients and has received funding from ALK-Abelló; she received consultant fees from LETI Pharma, ALK-Abelló, and Stallergenes and for lectures from ALK-Abelló, LETI Pharma, Stallergenes, HAL Allergy, and Novartis. R. Gerth van Wijk's institution has received funding for study participation and grant funds from Dutch Lung Foundation and STW, and he has received consultant and lecture fees from ALK-Abelló and Allergopharma and travel funding from the European Academy of Allergy and Clinical Immunology and UEMS. H.-H. Müller received fees from SynteractHCR and Deutschland GmbH for statistical analysis and his institution receives funding from St Jude Medical for statistical analysis not relevant to this work. J. Klinger's institution has received fees for review activities from SynteractHCR. F. Stolz is employed by Biomay. N. Breit has received consulting fees and travel support from Biomay. R. Henning is employed by Biomay AG, holds stock, and has patents with the company. R. Valenta's institution has grant funding from Biomay AG, Thermo Fisher, and Fresenius Medical Care, and he has received consultant fees from Biomay AG, Thermo Fisher, and Fresenius Medical Care. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 142 - N° 2
P. 497 - août 2018 Retour au numéro
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