Blinding of freeze-dried cod – a recipe developed for the FAST project

Background The FAST project (Food Allergy Specific ImmunoTherapy) aims at the development of safe and effective treatment of food allergies. Classical allergen-specific immunotherapy (SIT) for treatment of food allergy using subcutaneous injections with food extracts has proven to be effective but too dangerous due to anaphylactic side-effects. FAST aims at developing a safe alternative by replacing food extracts with hypo-allergenic recombinant major allergens, the active ingredients of SIT. Fish allergy is caused by a single major allergen, parvalbumin. In phase I and II of the study randomized double-blind placebo-controlled trials will be performed. A recipe for fishblinding does not exist and is needed to determine the clinical reactivity when including patients in the trial and to assess efficacy in the Phase II trial.