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

Probelte Pharma

Status: Enrolling

Conditions: Allergy

Study type: Observational

Funder types: Industry

Identifiers

NCT07309822

PRO-VEN-2023-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.