High- and Low-Dose Oral Sesame Immunotherapy: Interim Analysis of a Randomized Single-Center Open-Label Trial

Purpose: To compare the efficacy and safety of two sesame protein maintenance doses (300 mg vs 1200 mg) in pediatric oral immunotherapy (OIT) for sesame allergy. Patients and Methods: In this randomized, single-center, open-label trial (NCT05158413), 26 children aged 4– 17 years with confirmed sesame allergy were allocated 1:1 to receive either 300 mg or 1200 mg sesame protein as maintenance therapy following dose escalation. Inclusion criteria included positive skin prick test (SPT) and/or elevated sesame-specific IgE (sIgE), as well as clinical reactivity during oral food challenge (OFC). The primary endpoint was the proportion of patients tolerating 4000 mg of sesame protein at the end-of-treatment OFC. Secondary outcomes included changes in immunologic markers (SPT wheal size, sIgE, IgG4) and safety. Results: The rate of negative OFCs in our study (81.8% in the high-dose group and 69.2% in the low-dose group; p = 0.649) was comparable to outcomes reported in previous sesame OIT trials (19– 22), indicating similar efficacy across different maintenance dose regimens. Both groups showed significant reductions in SPT wheal size and increases in sesame-specific IgG4 (p < 0.005), with no significant changes in sIgE levels. The rate of World Allergy Organization (WAO) grade I adverse events per dose was comparable between groups (4.74% vs 3.88%, p = 0.706), with three WAO grade II events (2 high-dose, 1 low dose) and no grade III or adrenaline-requiring reactions reported. Conclusion: This interim analysis, based on a limited sample size, suggests that both low- and high-dose sesame OIT regimens are consistent with being effective and well tolerated in children, with similar immunologic responses and a favorable safety profile. Given the pilot nature of the study, the results should be interpreted as preliminary and hypothesis-generating, warranting confirmation in larger, long-term trials to optimize sesame OIT dosing strategies. Keywords: sesame allergy, oral immunotherapy, food allergy, oral food challenge