NCT06782217

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

Observational study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (multicentric) and data will be collected prospectively.

Detailed description

Observational study to evaluate the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting (safety evaluation), also it will be evulated the quality of life of the patient using one QoL questionnair before and after immunotherapy treatment. The patients aged equal or more than 14 years old, not gender differentiation, and sensitised to heminoptera venom. The total number of participants is expected to be 120. This study will be conducted in Spain (multicentric) and data will be collected prospectively.

Conditions

• Allergy, Insect Venom
• Allergy Insect Stinging
• Insect Sting Allergy

Interventions

Type	Name	Description
BIOLOGICAL	VENOX	Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-11-01
• Completion: 2027-02-01
• First posted: 2025-01-17
• Last updated: 2025-05-04

Locations

9 sites across 1 country: Spain