AllergyNCT07309822
Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.
An observational study of Allergy, run by Probelte Pharma S.L.U. at 13 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Allergy
- How many people
- 27 participants
- Where
- 13 sitesSpain
- Study dates
- 1 Feb 2025to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients older than 14 years with allergy to hymenoptera venom (Apis mellifera, Vespula spp., or Polistes dominula)
Who may be able to join
- 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®.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Spain13 sites, 13 recruiting
- Recruiting
Hospital Universitario Vall d' Hebron
Barcelona, Barcelona
Moisés Labrador
- Recruiting
Hospital Universitario de Bellvitge
Barcelona
Gustavo Jorge Molina
- Recruiting
Xarxa Assistencial I Universitària de Manresa
Barcelona
Laia Ferré
- Recruiting
Hospital General Universitario de Castellón
Castellon
Paula Viedma
- Recruiting
Hospital General la Mancha Centro
Ciudad Real
Estefanía Moreno
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real
Alberto Palacios
- Recruiting
Hospital Universitario Reina Sofía
Córdoba
Berta Ruiz
- Recruiting
Hospital Santa Caterina de Girona
Girona
Laia Prat
- Recruiting
Hospital Universitario Santa María de Lleida
Lleida
Lluís Marquès
- Recruiting
Hospital Universitario Fundación Alcorcón
Madrid
Teresa Alfaya
- Recruiting
Hospital Universitario la Paz
Madrid
Magdalena Lluch
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
David González de Olano
- Recruiting
Hospital Vega Baja
Orihuela
Ángel Ferrer
About this study
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
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
Read the 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.
- Conditions
- Allergy
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Feb 2025
- Primary completionMay 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Probelte Pharma S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309822
- Sponsor's protocol ID
- PRO-VEN-2023-01
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07309822
- Acronym / sponsor ID
- PRO-VEN-2023-01
- Conditions
- Allergy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Probelte Pharma S.L.U.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients older than 14 years with allergy to hymenoptera venom (Apis mellifera, Vespula spp., or Polistes dominula)
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by Probelte Pharma S.L.U. at 13 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inmaculada Buendía Jiménez, DVM (+34 608 933 618, inmaculadabuendia@probeltepharma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.