Safety Follow-Up Study of Immunotherapy for Hymenoptera Venom Allergy in Real-Life Settings in Spain

What this Trial Is About

This observational clinical follow-up study is designed to evaluate the safety of immunotherapy for treating hymenoptera venom allergy in real-life conditions. It focuses on patients allergic to venom from Apis mellifera bee or Vespula spp. wasp and includes the assessment of both controlled and spontaneous stings. The study is multicentric and will be conducted in Spain with prospective data collection. Participants will receive VENOX immunotherapy, an allergy vaccine targeting venom from wasps or bees, as per clinical recommendations. The study will follow patients for 12 months to monitor safety and tolerability, particularly the incidence of treatment-emergent adverse reactions. It also evaluates treatment effectiveness after reaching a maintenance dose and assesses immunological parameters and quality of life using the SEAIC questionnaire. During the study, participants will be observed over one year with regular follow-ups to collect data on adverse reactions and treatment impact. Researchers will monitor spontaneous natural stings and measure immunological changes. Quality of life related to venom allergy will also be assessed. The total number of participants is expected to be 80, all aged 14 years or older, and of any gender.

Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.