title: BASALIT trial: double-blind placebo-controlled allergen immunotherapy with rBet v 1-FV in birch-related soya allergy.
abstract: BACKGROUND
  Conflicting results exist on the effect of allergen immunotherapy (AIT) on pollen-related food allergy. We aimed to investigate the efficacy of one-year AIT with the folding variant (FV) of recombinant (r) Bet v 1 on birch-related soya allergy.
  
  
  METHODS
  Of 138 subjects with Bet v 1 sensitization, 82 were positive at double-blind placebo-controlled food challenge (DBPCFC) with soya. A total of 56 of 82 were randomized in the ratio of 2:1 (active: placebo). Per-protocol population (PPP) had received ≥150 μg of allergen or placebo preparation.
  
  
  METHODS
  lowest observed adverse effect levels (LOAEL), postinterventional occurrence of objective signs (objS) at any dose level, sIgE/IgG4 against Bet v 1 and Gly m 4. Between-group changes were investigated (ancova, Mann-Whitney U-test, Fisher exact test).
  
  
  RESULTS
  Baseline characteristics including LOAELs were comparable in both groups with objS and subjS occurring in 82% and 95% of active (n = 38) vs 78% and 83% of placebo group (n = 18). After AIT, objS occurred in 24% and 47%, respectively. LOAEL group differences showed a beneficial tendency (P = 0.081) for LOAELobjectivein PPP (30 active, 15 placebo). sIgG4 raised only in active group (Bet v 1: P = 0.054, Gly m 4: P = 0.037), and no relevant changes occurred for sIgE. Only 56% of the intended sample size was recruited.
  
  
  CONCLUSIONS
  For the first time, we present data on the effect of rBet v 1-FV on birch-related soya allergy. rBet v 1-FV AIT induced significant immunogenic effects. Clinical assessment showed a tendency in favour of the active group but did not reach statistical significance.
authors.affiliation: Department of Dermatology, Venerology and Allergology, Universität Leipzig, Leipzig, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Treudler
authors.affiliation: Clinical Trial Centre Leipzig (ZKS), Universität Leipzig, Leipzig, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Franke
authors.affiliation: Clinical Trial Centre Leipzig (ZKS), Universität Leipzig, Leipzig, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Schmiedeknecht
authors.affiliation: Allergy Unit, Department of Dermatology, University Hospital Zürich and Centre of Dermatology and Allergology, Luzerner Kantonsspital, Luzern, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Ballmer-Weber
authors.affiliation: Allergy Center Charité, Department of Dermatology, Venerology and Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Worm
authors.affiliation: Department of Dermatology and Allergology, MH Hannover, Hannover, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Werfel
authors.affiliation: Division of Clinical & Molecular Allergology Research Center Borstel, Airway Research Center North (ARCN) and Member of the German Center for Lung Research (DZL), Borstel, Germany.|Interdisciplinary Allergy Outpatient Clinic, Department of Internal Medicine, University of Lübeck, Lübeck, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Jappe
authors.affiliation: Department of Dermatology, Universität Tübingen, Tübingen, Germany.|Department of Dermatology and Allergology, Technical University Munich, Munich, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Biedermann
authors.affiliation: Department of Dermatology, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.|Center for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Schmitt
authors.affiliation: Department of Dermatology, Universität Münster, Münster, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Brehler
authors.affiliation: Department of Dermatology, Elbekliniken Buxtehude, Buxtehude, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Kleinheinz
authors.affiliation: Allergy- and Asthma Centre Westend, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Kleine-Tebbe
authors.affiliation: Day care clinic for Allergy and Dermatology, Kiel, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Brüning
authors.affiliation: Department of Dermatology and Allergology, Ludwig-Maximilian University, Munich, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Ruëff
authors.affiliation: Department of Dermatology and Allergology, Technical University Munich, Munich, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Ring
authors.affiliation: Department of Dermatology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Saloga
authors.affiliation: Department of Dermatology, Ruprecht-Karls-Universität Heidelberg, Heidelberg, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Schäkel
authors.affiliation: Division of Allergology, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Holzhauser
authors.affiliation: Division of Allergology, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Vieths
authors.affiliation: Department of Dermatology, Venerology and Allergology, Universität Leipzig, Leipzig, Germany.
authors.forename: J C
authors.initials: JC
authors.lastname: Simon
mesh_terms: D000328:Adult; D052179:Antigens, Plant / Q000276:immunology*; D029662:Betula / Q000276:immunology*; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods; D005260:Female; D005512:Food Hypersensitivity / Q000276:immunology* / Q000628:therapy*; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000276:immunology* / Q000628:therapy*; D012882:Skin Tests; D013025:Glycine max / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D052179:Antigens, Plant; C061312:Bet v 1 allergen, Betula; D007073:Immunoglobulin E
keywords: allergen-specific immunotherapy; birch food allergy; molecular; recombinant Bet v1; soya