Abstract | BACKGROUND: METHODS: We conducted a randomized, double-blind, placebo-controlled AIT study to determine safety, clinical efficacy and immunological mechanism of three subcutaneous injections of three BM32 doses adsorbed to aluminum hydroxide versus aluminum hydroxide (placebo) applied monthly to grass pollen allergic patients (n=70). Primary efficacy endpoint was the difference in total nasal symptom score (TNSS) through grass pollen chamber exposure before treatment and 4weeks after the last injection. Secondary clinical endpoints were total ocular symptom score (TOSS) and allergen-specific skin response evaluated by titrated skin prick testing (SPT) at the same time points. Treatment-related side effects were evaluated as safety endpoints. Changes in allergen-specific antibody, cellular and cytokine responses were measured in patients before and after treatment. RESULTS: Sixty-eight patients completed the trial. TNSS significantly decreased with mean changes of -1.41 (BM32/20μg) (P=0.03) and -1.34 (BM32/40μg) (P=0.003) whereas mean changes in the BM32/10μg and placebo group were not significant. TOSS and SPT reactions showed a dose-dependent decrease. No systemic immediate type side effects were observed. Only few grade 1 systemic late phase reactions occurred in BM32 treated patients. The number of local injection site reactions was similar in actively and placebo-treated patients. BM32 induced highly significant allergen-specific IgG responses (P<0.0001) but no allergen-specific IgE. Allergen-induced basophil activation was reduced in BM32 treated patients and addition of therapy-induced IgG significantly suppressed T cell activation (P=0.0063). CONCLUSION:
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Authors | Petra Zieglmayer, Margarete Focke-Tejkl, René Schmutz, Patrick Lemell, René Zieglmayer, Milena Weber, Renata Kiss, Katharina Blatt, Peter Valent, Frank Stolz, Hans Huber, Angela Neubauer, Anette Knoll, Friedrich Horak, Rainer Henning, Rudolf Valenta |
Journal | EBioMedicine
(EBioMedicine)
Vol. 11
Pg. 43-57
(Sep 2016)
ISSN: 2352-3964 [Electronic] Netherlands |
PMID | 27650868
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2016 Forschungsgesellschaft für Arbeitsphysiologie und Arbeitschutz e.V. Published by Elsevier B.V. All rights reserved. |
Chemical References |
- Allergens
- Antigens, Plant
- Epitopes, B-Lymphocyte
- Immunoglobulin G
- Recombinant Fusion Proteins
- Vaccines
- Immunoglobulin E
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Topics |
- Adult
- Allergens
(chemistry, immunology)
- Amino Acid Sequence
- Antigens, Plant
(chemistry, immunology)
- Basophils
(immunology, metabolism)
- Cell Degranulation
(immunology)
- Desensitization, Immunologic
(adverse effects, methods)
- Epitopes, B-Lymphocyte
(chemistry, immunology)
- Female
- Humans
- Immunoglobulin E
(immunology)
- Immunoglobulin G
(immunology)
- Lymphocyte Activation
(immunology)
- Male
- Middle Aged
- Models, Molecular
- Poaceae
(adverse effects)
- Pollen
(immunology)
- Protein Conformation
- Recombinant Fusion Proteins
(immunology)
- Rhinitis, Allergic, Seasonal
(diagnosis, immunology, therapy)
- Skin
(immunology)
- T-Lymphocytes
(immunology)
- Vaccines
(administration & dosage, adverse effects, immunology)
- Young Adult
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