Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltaven® With Apis mellifera, Polistes dominula or Vespula spp. allergic patients
Age 14 years or older at the time of study inclusion.
Written informed consent, duly signed and dated by the patient or by the legal representative in the case of minors.
Assent form duly signed and dated by the minor, when applicable.
Patients with allergy to Apis mellifera, Vespula spp., or Polistes dominula who have experienced a systemic reaction following a hymenoptera sting, either with involvement of multiple organs or exclusively cutaneous.
Patients with severe cardiovascular diseases, active malignant neoplasms or malignancies in remission within the last 5 years, non-stabilized systemic or organ-specific autoimmune diseases, severe mental disorders, or other relevant chronic diseases that may interfere with the study results.
Patients with known allergy to any of the vaccine excipients.
Pregnant patients, patients planning to become pregnant during the study period, or breastfeeding patients.
Patients who have received hymenoptera immunotherapy within the 5 years prior to inclusion or during the study.
Patients older than 14 years with allergy to hymenoptera venom (Apis mellifera, Vespula spp., or Polistes dominula)
Cohort
Prospective
Not listed
To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen
Proportion of patients who show tolerance (absence of systemic reaction) to the controlled sting challenge test conducted during the challenge visit, or to an accidental sting in a rural setting during the continuation treatment period
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