Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of XXXX .

@entity1 @entity9285 @entity565 @entity4135 @entity56 @entity12525
BACKGROUND: A new @entity9285 ( @entity9285 ) product adsorbed on @entity12525 has been developed with a short and simplified up-dosing phase, containing a biologically standardized allergen pollen extract from @entity4135 . OBJECTIVE: To assess the tolerability profile of the updosing phase and its immunological effect, in terms of specific IgG4 and IgE levels and immediate skin reactivity. MATERIAL AND METHODS: The study was an exploratory, multi-centre, open-label, single-arm, phase II/III clinical trial. Adults with a clinical history of @entity56 with/without @entity565 due to sensitization to olive pollen were selected. Five up-dosing doses (300, 600, 3000, 6000 and 15000SQ+) were administered at weekly intervals, followed by a maintenance dose (15000SQ+) after 2  weeks. Adverse events were collected during the 30  min observation period after injections, after a telephone contact 2  days after each visit, and after reviewing the subjects' diary. IgG4 and IgE levels and immediate skin reactivity were evaluated at the beginning and at the end of the trial. RESULTS: Ninety-three subjects were included in the trial (mean age, 35.7        10.3  years; @entity1 , 66.7  %). A total of 95 adverse drug reactions, all mild in intensity and non-serious, were reported during the trial: 85 local in 34.4  % subjects, 9 systemic in 4.3  % subjects and one non-specific (grade 0). Within 6  weeks, significant changes in IgG4 and IgE levels and in immediate skin reactivity to @entity4135 were accomplished. CONCLUSION: This new @entity9285 derived from pollen of @entity4135 presented a good tolerability profile and induced significant immunological responses already after a 6  week treatment. However, the non-controlled design may limit the interpretation of these results. TRIAL REGISTRATION: EudraCT no: 2011-004852-20; ClinicalTrials.gov Identifier: NCT01674595.
