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

NCT07309822 | Recruiting

• 1 other identifier: PRO-VEN-2023-01
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 13

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

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

• To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen

  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

  9 months

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 14 years with allergy to hymenoptera venom (Apis mellifera, Vespula spp., or Polistes dominula)

You may qualify if:

• 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®.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Probelte Pharma S.L.U.: lead

Study Sites (13)

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

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Inmaculada Buendía Jiménez, DVM

CONTACT

+34 608 933 618; inmaculadabuendia@probeltepharma.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

ES (13)