RecruitingNCT06782217
Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
Sponsor
Inmunotek S.L.
Enrollment
120 participants
Start Date
Sep 1, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 14 Years
Inclusion Criteria4
- 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.
- Age equal to or older than 14 years, without gender differences.
- Not having received immunotherapy with hymenoptera venom in the previous 5 years.
- 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 Criteria6
- Pregnant or breastfeeding women.
- Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.
- Participants who do not agree to participate and/or do not sign the informed consent form.
- Participants who do not comply with the medical indications or do not show cooperation with respect to the immunotherapy treatment.
- Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive treatment.
- Participants in whom the administration of immunotherapy is contraindicated.
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Interventions
BIOLOGICALVENOX
Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT06782217