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

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

This project will try subcutaneous Beltaven allergy shots in people aged 14 and up who have had systemic reactions to Apis mellifera, Polistes dominula, or Vespula stings to see if they are safe and helpful in routine care.

Quick facts

• Study type: Observational
• Enrollment: 27 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Probelte Pharma S.L.U. (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 13 sites (Barcelona, Barcelona and 12 other locations)
• Trial ID: NCT07309822 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 14 or older who have had a systemic allergic reaction to a honeybee, paper wasp, or yellow jacket sting, have positive intradermal and specific IgE tests, and are willing to receive Beltaven immunotherapy.

Not a fit: Patients with severe cardiovascular disease, recent or active malignancy, uncontrolled autoimmune disease, severe mental disorders, or those who lack positive diagnostic tests or are unwilling to receive immunotherapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could reduce the risk of systemic sting reactions and improve tolerance to honeybee and wasp venom in people with these allergies.

How similar studies have performed: Venom immunotherapy for insect-sting allergy is an established and effective approach, though this study documents the safety and effectiveness of the specific Beltaven product in routine practice.

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.

Where this trial is running

Barcelona, Barcelona and 12 other locations

• 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)
• Hospital Universitario Reina Sofía — Córdoba, Spain (Recruiting)
• Hospital Santa Caterina de Girona — Girona, Spain (Recruiting)
• Hospital Universitario Santa María de Lleida — Lleida, Spain (Recruiting)
• Hospital Universitario Fundación Alcorcón — Madrid, Spain (Recruiting)
• Hospital Universitario la Paz — Madrid, Spain (Recruiting)
• Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
• Hospital Vega Baja — Orihuela, Spain (Recruiting)

Study contacts

• Study coordinator: Inmaculada Buendía Jiménez, DVM

Conditions Allergy