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

Recruiting

• Conditions: Allergy, Insect Venom; Allergy Insect Stinging; Insect Sting Allergy
• Interventions: Biological: VENOX

• Registration Number: NCT06782217
• Lead Sponsor: Inmunotek S.L.

Brief 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.

Detailed Description

Observational study to evaluate the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting (safety evaluation), also it will be evulated the quality of life of the patient using one QoL questionnair before and after immunotherapy treatment.

The patients aged equal or more than 14 years old, not gender differentiation, and sensitised to heminoptera venom. The total number of participants is expected to be 120.

This study will be conducted in Spain (multicentric) and data will be collected prospectively.

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-11-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients allergic to hymenoptera venom	VENOX	Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX immunotherapy (ATC code: V01AA07).

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Evaluation of the immunogenicity of the participant after 6 and 12 months of treatment.	12 months	Immunological study: total IgE, and specific IgE, IgG4, IgG1 (total extract and molecular components of Vespula spp. and Apis mellifera). The immunological analysis will be performed according to the usual clinical practice of the center and the serum samples will be stored for the complete analysis in the facilities of the sponsor, using the ALEX technique.
Quality of life in treated participants after 6 and 12 months of treatment.	12 months	Questionnaire of "Quality of Life in People Allergic to Hymenoptera Venom" (HiCaVi), property/copyright of SEAIC (Sociedad Española de Alergología e Inmunología Clínica).; The quality of life questionnaire consists of 14 questions, the first nine questions are mandatory. The score for each question is inverse to the order of the answer, i.e., the first answer scores 7 and the seventh answer scores 1.; The score shall be obtained by adding up all the questions answered and dividing by the total number of questions answered.; The total score goes from 1 to 7, being the 1 the worst quality and the 7 the best one.
Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural repicures during the 1-year follow-up.	12 months	Registration of allergic reactions after spontaneous natural stings.

Trial Locations

Locations (9)

Hospital Arquitecto Marcide; 🇪🇸 Ferrol, A Coruña, Spain

Hospital Virgen del Puerto Plasencia; 🇪🇸 Plasencia, Cáceres, Spain

Hospital Público Da Mariña; 🇪🇸 Burela De Cabo, Lugo, Spain

Hospital Comarcal de Monforte de Lemos; 🇪🇸 Monforte De Lemos, Lugo, Spain

Hospital de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Vall d' Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Spain

Complejo Hospitalario Universitario de Ourense; 🇪🇸 Ourense, Spain

Hospital Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain