Clinical Trials in Spain / NCT06782217
Recruiting
Observational
Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
NCT06782217 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Allergy, Insect VenomAllergy Insect StingingInsect Sting Allergy
Investigational drug(s) / intervention(s)
VENOX: Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Study summary
Observational study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (multicentric) and data will be collected prospectively.
Eligibility
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.
Primary outcome measure(s)
- Incidence of treatment-Emergent adverse reactions (safety and tolerability) in patients diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.) with indication to receive immunotherapy with the causative venom. — 12 months
Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Arquitecto Marcide | Ferrol | A Coruña | Not Yet Recruiting |
| Hospital Virgen del Puerto Plasencia | Plasencia | Cáceres | Recruiting |
| Hospital Público Da Mariña | Burela de Cabo | Lugo | Recruiting |
| Hospital Comarcal de Monforte de Lemos | Monforte de Lemos | Lugo | Recruiting |
| Hospital de A Coruña | A Coruña | Spain | Recruiting |
| Hospital Vall d' Hebron | Barcelona | Spain | Recruiting |
| Hospital Universitario Lucus Augusti | Lugo | Spain | Recruiting |
| Complejo Hospitalario Universitario de Ourense | Ourense | Spain | Recruiting |
| Hospital Universitario de Pontevedra | Pontevedra | Spain | Recruiting |
More Inmunotek S.L. trials in Spain
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06782217 on ClinicalTrials.gov ↗ ← All trials in Spain