Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.

This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltaven in Apis mellifera, Polistes dominula or Vespula spp (children and adults) in routine medical care.

Primary outcomes

• To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen [9 months]: 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

Sex: All, ages: 14 Years to any

Inclusion Criteria:

* 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.
* Positive intradermal test (mean wheal diameter ≥ 5 mm) with Beltaven® diagnostic (allergenic extract of Apis mellifera, Vespula spp., or Polistes dominula).
* Positive specific IgE test from class 1 onwards (≥ 0.35 kUA/L).
* Patients willing to receive immunotherapy with Beltaven®.

Exclusion Criteria:

* 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 who are to receive immunotherapy with another specific allergen different from the investigational treatment during the study period.
* Patients with confirmed sensitization to two or more hymenoptera species as demonstrated by CAP inhibition testing.
* Patients with thrombocytopenic purpura and vasculitis, rhabdomyolysis, or renal failure.