Evaluating the safety of immunotherapy for insect venom allergy
Official title: Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
Run by Inmunotek S.L. · NCT06782217 · Data updated 2026-11-12
This study is testing the safety of a new treatment for people aged 14 and older with insect venom allergies to see how well it works and if it causes any side effects.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Inmunotek S.L. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 9 sites (Ferrol, A Coruña and 8 other locations) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | November 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | May 4, 2025 |
| Trial ID | NCT06782217 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 14 and older who are allergic to Hymenoptera venom and have not received immunotherapy in the past five years.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have received immunotherapy in the last five years will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the safety of immunotherapy for patients with Hymenoptera venom allergy. It will analyze adverse reactions to the immunotherapy as well as allergic reactions to spontaneous hymenoptera stings. The study will involve participants aged 14 and older who are sensitized to hymenoptera venom and will collect data prospectively across multiple centers in Spain. Additionally, the quality of life of participants will be evaluated using a questionnaire before and after treatment.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of immunotherapy for patients suffering from Hymenoptera venom allergies.
How similar studies have gone: Other studies have shown promising results with immunotherapy for insect venom allergies, indicating that this approach is supported by prior research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The study population consisted of allergic participants indicated for treatment with immunotherapy with hymenoptera venom (Apis mellifera or Vespula spp.) according to standard clinical practice. 2. Age equal to or older than 14 years, without gender differences. 3. Not having received immunotherapy with hymenoptera venom in the previous 5 years. 4. That they agree to participate in the study and sign the informed consent form. In the case of minors, the parent or guardian of the participant must also sign the informed consent form. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study. 3. Participants who do not agree to participate and/or do not sign the informed consent form. 4. Participants who do not comply with the medical indications or do not show cooperation with respect to the immunotherapy treatment. 5. Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive treatment. 6. Participants in whom the administration of immunotherapy is contraindicated.
Where it's running
-
Hospital Virgen del Puerto Plasencia
Plasencia, Cáceres, Spain Recruiting -
Hospital Público Da Mariña
Burela de Cabo, Lugo, Spain Recruiting -
Hospital Comarcal de Monforte de Lemos
Monforte de Lemos, Lugo, Spain Recruiting -
Hospital de A Coruña
A Coruña, Spain Recruiting -
Hospital Vall d' Hebron
Barcelona, Spain Recruiting -
Hospital Universitario Lucus Augusti
Lugo, Spain Recruiting
Show 3 more locations
-
Complejo Hospitalario Universitario de Ourense
Ourense, Spain Recruiting -
Hospital Universitario de Pontevedra
Pontevedra, Spain Recruiting -
Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain Not yet recruiting
Study contacts
- Principal investigator: Francisco Javier Carballada, MD — Hospital Universitario Lucus Augusti
- Study coordinator: Miguel Casanovas, MD
- Email: mcasanovas@inmunotek.com
- Phone: +3491208942
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Immunotherapy for treating insect venom allergies.
This study is testing a new treatment for people aged 14 and older with insect venom allergies to see if it can safely reduce their allergic reactions in real-life situations.
-
Different forms of IgE in health and disease.
We will test whether different forms of IgE in the blood differ between healthy adults and people with allergies, chronic spontaneous urticaria, recent anaphylaxis, mastocytosis, hereditary alpha tryptasemia, X‑linked agammaglobulinemia, or those undergoing venom/medication desensitization.
-
Long-term effects of jack jumper ant venom immunotherapy
This trial will test whether people who completed 3–6 years of jack jumper ant venom immunotherapy still have protection when given a supervised sting challenge after being off treatment for 18 months to 5 years.
-
Testing B-regulatory Cells as a Marker for Allergen Immunotherapy Response
This study tests whether changes in blood B-regulatory cells can signal successful allergen immunotherapy in adults with pollen, dust mite, or insect venom allergies.
-
Evaluating a new method to identify vespid venom allergy risks
This study is testing a new blood test to see if it can help identify people at risk for severe allergic reactions to wasp and hornet stings without having to actually sting them.
-
Understanding why some patients don't respond to bee venom allergy treatment
This study looks at why some people with bee venom allergies don't get better with treatment and tries to find out if certain allergens make the treatment less effective.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.