Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Allergy. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Prospective Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp
Overview
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.
Primary outcome measures
- To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen [Time frame: 9 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 13 centers
- Hospital Universitario Vall d' Hebron — Barcelona
- Hospital Universitario de Bellvitge — Barcelona
- Xarxa Assistencial I Universitària de Manresa — Barcelona
- Hospital General Universitario de Castellón — Castellon
- Hospital General la Mancha Centro — Ciudad Real
- Hospital General Universitario de Ciudad Real — Ciudad Real
- Hospital Universitario Reina Sofía — Córdoba
- Hospital Santa Caterina de Girona — Girona
- … and 5 more centers
Identifiers
NCT: NCT07309822 · PRO-VEN-2023-01