Beltaven shots for allergy to honeybee, paper wasp, or yellow jacket

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open, multi-center, non-interventional follow-up of patients receiving subcutaneous allergen-specific immunotherapy (SCIT) with Beltaven for hymenoptera venom allergy in routine clinical practice. Patients aged 14 years and older with documented systemic reactions to Apis mellifera, Polistes dominula, or Vespula spp. and positive intradermal and specific IgE tests are followed while receiving Beltaven per treating physicians' usual care. The study collects safety data (including systemic reactions and adverse events) and clinical effectiveness signals during regular visits without experimental treatment procedures. Data are gathered across several hospitals in the Barcelona area to characterize real-world tolerability and outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Vall d' Hebron
  Barcelona, Barcelona, Spain Recruiting
• Hospital Universitario de Bellvitge
  Barcelona, Spain Recruiting
• Xarxa Assistencial I Universitària de Manresa
  Barcelona, Spain Recruiting
• Hospital General Universitario de Castellón
  Castellon, Spain Recruiting
• Hospital General la Mancha Centro
  Ciudad Real, Spain Recruiting
• Hospital General Universitario de Ciudad Real
  Ciudad Real, Spain Recruiting

Study contacts

• Study coordinator: Inmaculada Buendía Jiménez, DVM
• Email: inmaculadabuendia@probeltepharma.es
• Phone: +34 608 933 618

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.