A multi centre randomised placebo-controlled double-blind clinical trial for the evaluation of efficacy of specific immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen r Bet v1-FV on Bet v 1 associated soy allergy

INTERVENTION: Product Name: rBet v1‐FV Pharmaceutical Form: Suspension for injection Other descriptive name: rBet v1‐FV Concentration unit: µg microgram(s) Concentration type: range Concentration number: 0.75‐80 Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use CONDITION: Immediate type allergy to soy proteins in patients with birch pollinosis ; MedDRA version: 13.1 Level: LLT Classification code 10057630 Term: Protein allergy System Organ Class: 10021428 ‐ Immune system disorders ; MedDRA version: 13.1 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 10021428 ‐ Immune system disorders ; MedDRA version: 13.1 Level: PT Classification code 10016946 Term: Food allergy System Organ Class: 10021428 ‐ Immune system disorders Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: To determine the efficacy of specific subcutaneous immunotherapy (SCIT) against birch allergen Bet v 1 on birch pollen associated soy allergy. Primary end point(s): Threshold dose of soy protein leading to first symptoms at DBPCFC (lowest observed adverse effect level ‐ LOAEL); two primary endpoints (without hierarchy) ‐ LOAELobj for clinically objective and LOAELsubj for subjective symptoms Secondary Objective: To determine the efficacy of SCIT against birch allergen Bet v 1 on ; • Reactivity in SPT to soy; • Levels of IgE and IgG4 for Bet v 1, Gly m 4, purified birch associated food allergens (apple, carrot, celeriac, cherry, hazel); • Food Allergy related Quality of Life Questionnaire ; SECONDARY OUTCOME: Secondary end point(s): Effects of SCIT on; • Overall rates for the occurrence of any objective symptoms pre / post SCIT per group; • Cumulative VAS scores regarding the overall discomfort of patients in terms of DBPCFC pre / post SCIT per group; • reactivity to soy protein in skin prick test (as measured in mm of wheal reaction) ; • specific IgE levels for Bet v 1and Gly m4 (as measured in kU/l); • specific IgE levels for purified birch associated food allergens (apple‐ Mal d 1, carrot‐ Dau c1, cherry‐ Pru av 1, celeriac‐ Api g1, hazel‐ Cor a 1;as measured in kU/l); • specific IgG4 levels for Bet v 1and Gly m4 (as measured in kU/l); • specific IgG4 levels for purified birch associated food allergens (apple‐ Mal d 1, carrot‐ Dau c1, cherry‐ Pru av 1, celeriac‐ Api g1, hazel‐ Cor a 1; as measured in kU/l); • Food allergy‐related quality of life as measured via FAQLQ questionnaire including the FAIM questionnaire.; • patient’s and investigator’s judgment whether verum or placebo SCIT was applied to a patient (before un‐blinding the allocation of treatment arm).; INCLUSION CRITERIA: • Male or female adult patients aged 18 – 65 years inclusive, legally competent • Written informed consent • Suspected birch pollinosis • Sensitization to birch pollen as demonstrated by positive SPT to birch (wheal > 3mm) • Specific IgE for Bet v 1 (> ImmunoCAP class 2) and Gly m 4 (> ImmunoCAP class 1) to be determined in laboratory at trial site (Investigation 2) • Clinical relevance of Gly m4 sensitization as demonstrated by positive DBPCFC to soy proteins (Investigation 4) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range