Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy

Launched by INMUNOTEK S.L. · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a treatment called immunotherapy for people who are allergic to insect stings, specifically from bees and wasps. Immunotherapy involves giving small, controlled amounts of the allergen (in this case, venom from these insects) to help the body build up a tolerance over time. The researchers want to see if this treatment is safe and how people react to it, both in terms of the treatment itself and if they happen to get stung by an insect while in the study. The trial will take place in several locations in Spain and is currently looking for participants.

To be eligible for this study, participants must be at least 14 years old and have a confirmed allergy to hymenoptera venom. They should not have received any venom immunotherapy in the past five years and must be able to agree to participate. Pregnant or breastfeeding women, as well as those with certain medical conditions or who have had recent immunotherapy, are not eligible. If you join the study, you can expect to receive the immunotherapy treatment and be monitored closely for any reactions or side effects. Your participation will help researchers understand how to make this treatment safer and more effective for those with insect sting allergies.

Gender

ALL

Eligibility 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.