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ID06782217

Observational Study on the Safety of VENOX Immunotherapy for Hymenoptera Venom Allergy in Patients Aged 14 and Older

Led by Inmunotek S.L. · Updated on 2025-05-04

120

Participants Needed

9

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting an observational study to assess the safety of immunotherapy for treating Hymenoptera venom allergy, which is an allergic reaction to stings from insects like bees Apis mellifera or wasps Vespula spp.. The study also aims to evaluate how patients quality of life changes before and after receiving immunotherapy. This research will take place across multiple centers in Spain and gather data prospectively. Participants in this study are people aged 14 years and older who are allergic to Hymenoptera venom and have been recommended to receive immunotherapy with VENOX, an allergy vaccine targeting the venom of wasps or bees. The study involves monitoring patients receiving this immunotherapy as part of their clinical care, without any placebo or control group, focusing on real-world treatment safety and patient experience. During the study, participants will be followed for up to 12 months to track any adverse reactions to the immunotherapy and allergic reactions to natural insect stings. Quality of life will be assessed using questionnaires before and after treatment. Researchers will also evaluate immune response at 6 and 12 months and monitor treatment effectiveness once maintenance dosing is reached. Data collection will include safety, tolerability, and patient-reported outcomes to understand the impact of immunotherapy in real clinical settings.

CONDITIONS

Brief Title

Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy

Research Team

M

Miguel Casanovas, MD

R

Raquel Caballero, BSc

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