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There is much disagreement concerning the immunological basis of immunotherapy. A shift from T-helper 2 (Th2) to T-helper 1 immunity against allergens, the induction of regulatory T-cells suppressing Th2-activity and the induction of blocking IgG antibodies each have their advocates for being pivotal in the protective mechanism of SIT. The number of SIT studies that have included in depth immunological analyses covering all these aspects in the same trial is very limited. Indeed, for immunotherapy of food allergy such studies are not at all available. For future improvements to the efficacy of SIT, it is of the utmost importance to elucidate the mechanism of protection observed during SIT.

In the context of this proposal we focus on IgE-mediated food hypersensitivity, hereafter referred to as food allergy. The only available treatment for food allergy is avoidance, in conjunction with rescue medication in case of accidental exposure. Hidden allergens in composite foods or unwanted contaminations and occasional poor adherence to dietary restrictions make avoidance difficult and ineffective. Most food allergies are chronic life-long diseases that are potentially life-threatening. It is the main cause of emergency hospital ward visits for anaphylaxis. Food allergy is estimated to affect around 10 million EU citizens, and the threat of severe anaphylaxis has great impact on the quality of life of patients and their relatives. A curative treatment for food allergy is the only way to change this situation. Allergen-specific immunotherapy (SIT) is the only treatment available that comes close to a cure by targeting the immunological basis of the disease. During classical SIT allergic patients receive monthly injections with allergen extract for three to five years. It is a successful treatment for insect venom allergies and for respiratory allergies like rhino-conjunctivitis to pollen and house dust mite. Despite that almost 95% of the market for treatment of allergic diseases is covered by symptomatic drugs. The burden of monthly injections for prolonged periods and the variable quality of products based on biological extracts provide the basis for the current niche position of SIT. For food allergy, SIT is not used at all. Attempts to treat food allergies by SIT have failed because anaphylactic side-effects were too numerous and severe.