Evaluating the safety of immunotherapy for insect venom allergy

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

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
• Enrollment: 120 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Inmunotek S.L. (industry)
• Drugs / interventions: immunotherapy
• Locations: 9 sites (Ferrol, A Coruña and 8 other locations)
• Trial ID: NCT06782217 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who are pregnant, breastfeeding, or have received immunotherapy in the last five years will not benefit from this study.

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 performed: Other studies have shown promising results with immunotherapy for insect venom allergies, indicating that this approach is supported by prior research.

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.

Where this trial is running

Ferrol, A Coruña and 8 other locations

• Hospital Arquitecto Marcide — Ferrol, A Coruña, Spain (NOT_YET_RECRUITING)
• 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)
• Complejo Hospitalario Universitario de Ourense — Ourense, Spain (RECRUITING)
• Hospital Universitario de Pontevedra — Pontevedra, Spain (RECRUITING)

Study contacts

• Principal investigator: Francisco Javier Carballada, MD — Hospital Universitario Lucus Augusti
• Study coordinator: Miguel Casanovas, MD

Conditions: Allergy, Insect Venom, Allergy Insect Stinging, Insect Sting Allergy, Allergy, Immunothepary, Apis mellifera, Vespula spp., Insect venom