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New allergy shot could take the sting out of bee and wasp allergies

NCT ID NCT07309822

Disease control Sponsor: Probelte Pharma S.L.U. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing an allergy immunotherapy called Beltaven for people allergic to bee or wasp stings. Researchers want to see if a 3-week series of shots helps patients tolerate stings without a severe reaction. The study will follow 27 participants aged 14 and older who have had a systemic reaction to a sting before.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Beltaven (allergy immunotherapy shot)
What this could lead to
If successful, this could show that Beltaven helps people with bee or wasp allergies tolerate stings without severe reactions.
What could go wrong
This is a small observational study with only 27 people, so results may not apply to everyone. There is always a risk of allergic reactions to the shots themselves.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

allergic disease venom allergy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allergy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital General Universitario de Castellón

    RECRUITING

    Castellon, Spain

  • Hospital General Universitario de Ciudad Real

    RECRUITING

    Ciudad Real, Spain

  • Hospital General la Mancha Centro

    RECRUITING

    Ciudad Real, Spain

  • Hospital Santa Caterina de Girona

    RECRUITING

    Girona, Spain

  • Hospital Universitario Fundación Alcorcón

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Reina Sofía

    RECRUITING

    Córdoba, Spain

  • Hospital Universitario Santa María de Lleida

    RECRUITING

    Lleida, Spain

  • Hospital Universitario Vall d' Hebron

    RECRUITING

    Barcelona, Barcelona, Spain

  • Hospital Universitario de Bellvitge

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario la Paz

    RECRUITING

    Madrid, Spain

  • Hospital Vega Baja

    RECRUITING

    Orihuela, Spain

  • Xarxa Assistencial I Universitària de Manresa

    RECRUITING

    Barcelona, Spain

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