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Background: The objective of this study was to determine whether a cluster scheme of allergic immunotherapy (AIT), starting administration of the therapeutic extract with the highest available concentration vial (vial B) of Allergovit®, affords adequate safety and tolerance under conditions of routine clinical practice. Methods: An observational study with retrospective collection of data from protocolled patients' medical records was designed. Patients of 5-65 years old with diagnosis of rhinitis with or without bronchial allergic asthma and hypersensitivity to pollen were selected. Patients were treated with subcutaneous Allergovit®, starting with cluster high doses (500 + 500 TU/1500 + 1500 TU/3000 + 3000 TU) on days 1/8/15 of the build-up phase and 6000 TU monthly on the maintenance phase for 2 years. Results: One hundred and ten patients were included being 51.8% (57) females with a mean age of 30.9 years (95% CI 28.1-33.6). During the first year of AIT, 46 patients suffered 69 adverse reactions (5% of injections). Local reactions were observed in 3.03% of injections (60), and systemic reactions in 0.46% of injections (9). Fifteen systemic reactions were observed in 11 patients during 2 years: 3/Grade 1, 11/Grade 2 and 1/Grade 3, all of them were resolved in 1 day. Conclusions: Cluster AIT reduces the vaccination build-up period, reaching the desired maintenance dose within 2 weeks. The low number of local and systemic reactions observed, the low severity and the resolution of all of them mostly in only 1 day, and the similar safety results observed in other cluster schemes allow to conclude that the cluster scheme evaluated (500 + 500 TU/1500 + 1500 TU/3000 + 3000 TU) was safe for the patients.

This project is pioneering in terms of its purpose - the definition of quality standards for AITCs - and for the use of structured participation techniques - a combination of the RAND/UCLA and Delphi methods. The results, together with some minimum standards for quality and safety in administering AIT, is a set of quality criteria for AITC accreditation supported by a broad panel of SEAIC experts.