Allergy
Conditions
Brief summary
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
Detailed 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.
Interventions
None listed
Sponsors
Probelte Pharma S.L.U.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Contacts
Primary ContactInmaculada Buendía Jiménez, DVM
Outcome results
None listed