title: The BASALIT multicenter trial: Gly m 4 quantification for consistency control of challenge meal batches and toward Gly m 4 threshold data.
abstract: The BASALIT clinical trial (EudraCT 2009-011737-27) investigated efficacy of birch allergen immunotherapy on lowest observed adverse effect levels after soy food challenge in patients with birch-associated and Gly m 4 allergen mediated soy allergy. Thus, consistently stable Gly m 4 levels were required in standardized challenge meals.
  
  
  
  Soy meal included soy protein isolate (SPI, 88% total protein). A Gly m 4 specific ELISA was developed and validated. Six SPIs and 24 meal batches were analyzed for Gly m 4. (Repeated-measures) analyses of variance were done to identify potential changes between batches and time intervals. Gly m 4 was below the ELISA detection limit (2 ng/mL) in placebo batches. With <20% mean coefficient of variation, Gly m 4 levels were consistent in 24 soy meal batches and within individual 12-wk shelf-life.
  
  
  
  The novel Gly m 4 specific ELISA proved consistency of challenge meal batches over a 56-month study period. With an average of 178 μg/g Gly m 4 in SPI, Gly m 4 lowest observed adverse effect level can be calculated once clinical lowest observed adverse effect level data based on SPI are available. Hence, sensitivity of patients can be correlated to the relevant allergen content instead of total protein of the allergenic source.
authors.affiliation: Division of Allergology, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Holzhauser
authors.affiliation: Zentrum für Klinische Studien, Universität Leipzig, Leipzig, Germany.
authors.forename: Annegret
authors.initials: A
authors.lastname: Franke
authors.affiliation: Klinik für Dermatologie, Venerologie und Allergologie, Universität Leipzig, Leipzig, Germany.
authors.forename: Regina
authors.initials: R
authors.lastname: Treudler
authors.affiliation: Zentrum für Klinische Studien, Universität Leipzig, Leipzig, Germany.
authors.forename: Anett
authors.initials: A
authors.lastname: Schmiedeknecht
authors.affiliation: Division of Allergology, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Randow
authors.affiliation: Division of Clinical & Molecular Allergology, Research Center Borstel, Borstel, Germany.
authors.forename: Wolf-Meinhard
authors.initials: WM
authors.lastname: Becker
authors.affiliation: Allergens Unit, ThermoFisher Scientific, Uppsala, Sweden.
authors.forename: Jonas
authors.initials: J
authors.lastname: Lidholm
authors.affiliation: Division of Allergology, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Vieths
authors.affiliation: Klinik für Dermatologie, Venerologie und Allergologie, Universität Leipzig, Leipzig, Germany.
authors.forename: Jan-Christoph
authors.initials: JC
authors.lastname: Simon
mesh_terms: D052179:Antigens, Plant / Q000009:adverse effects / Q000032:analysis* / Q000276:immunology; D029662:Betula / Q000009:adverse effects / Q000276:immunology; D002986:Clinical Trials as Topic; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards*; D005504:Food Analysis / Q000379:methods / Q000592:standards*; D005512:Food Hypersensitivity / Q000276:immunology; D061353:Food Storage; D006801:Humans; D057230:Limit of Detection; D015337:Multicenter Studies as Topic; D015203:Reproducibility of Results; D030262:Soybean Proteins / Q000032:analysis / Q000302:isolation & purification
chemical_list: D052179:Antigens, Plant; C530536:Gly m 4 allergen, Glycine max; D030262:Soybean Proteins
keywords: Birch pollen allergy; ELISA; Eliciting dose; Gly m 4; Soybean allergy