Observational Prospective Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Probelte Pharma S.L.U.
- Enrollment
- 27
- Locations
- 13
- Primary Endpoint
- To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported