Аннотация
BACKGROUND: Mugwort pollen allergy, largely driven by the major allergen Art v 1, is a major cause of seasonal allergic rhinitis and asthma. Although recombinant allergens enable standardized allergen-specific immunotherapy, clinical data on ultra-short regimens remain limited. We conducted the first-in-human evaluation of an ultra-short recombinant Art v 1 subcutaneous immunotherapy (SCIT) regimen in adults with mugwort-induced allergic rhinitis. METHODS: In this randomized, double-blind, placebo-controlled Phase I study conducted outside the pollen season, 30 adults were assigned (1:2:2) to placebo (n = 6) or recombinant Art v 1 formulated with the oil-based adjuvant and administered at cumulative doses of 22 μg (n = 12) or 44 μg (n = 12) over four weekly injections. Primary endpoints were safety and tolerability. Secondary exploratory endpoints included allergen-specific antibody responses, IgE-blocking activity, cytokine production by allergen-restimulated peripheral blood mononuclear cells, and skin prick test (SPT) reactivity. RESULTS: , increased IgE-blocking activity, and stable total IgE levels. Cytokine profiling demonstrated dose-dependent immune deviation, with increased IL-10 and IL-2 at 22 μg and induction of IFN-γ-associated responses at 44 μg, without activation of Th2-related cytokines. SPT reactivity was reduced in both active groups, with no change in placebo. CONCLUSIONS: An ultra-short recombinant Art v 1 SCIT regimen was safe and induced rapid, dose-dependent allergen-specific immune modulation, supporting further clinical development. CLINICALTRIALS: GOV: NCT07317960.