Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.

NCT06790368 | Recruiting

• 1 other identifier: ITK-VENOX-2023-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.

Conditions

Allergy, Insect Venom; Allergy Insect Stinging; Insect Sting Allergy

Keywords

Allergy; Immunotherapy; Apis mellifera; Vespula sp; controlled sting

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).

  Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).

  12 months

Secondary Outcomes (3)

• Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural stings during the 1-year follow-up.

  12 months

• Immunological parameters of the participants after 12 months of treatment.

  12 months

• SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.

  12 months

Study Arms (1)

Patients allergic to hymenoptera venom

Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX inmunotherapy (ATC code: V01AA07)

Biological: VENOX

Interventions

VENOX BIOLOGICAL

Treatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.

Patients allergic to hymenoptera venom

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of both gender aged 14 years or more diagnosed of allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive ITVH according to standard clinical practice.

You may qualify if:

• The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.
• Participants of both sexes aged 14 years or more.
• Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.
• Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.

You may not qualify if:

• 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 medical indications or do not cooperate with immunotherapy treatment.

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (3)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

RECRUITING

Hospital Reina Sofía

Córdoba, Spain

RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

RECRUITING

Related Publications (3)

• Krishna MT, Ewan PW, Diwakar L, Durham SR, Frew AJ, Leech SC, Nasser SM; British Society for Allergy and Clinical Immunology. Diagnosis and management of hymenoptera venom allergy: British Society for Allergy and Clinical Immunology (BSACI) guidelines. Clin Exp Allergy. 2011 Sep;41(9):1201-20. doi: 10.1111/j.1365-2222.2011.03788.x.

  PMID: 21848758 BACKGROUND

• Ruiz-Leon B, Martinez San Ireneo M, de la Roca F, Arenas L, Alfaya Arias T, Cordobes C, Marques L, Vega A, Moreno-Aguilar C. The Lights and the Shadows of Controlled Sting Challenge With Hymenoptera. J Investig Allergol Clin Immunol. 2022 Oct 11;32(5):357-366. doi: 10.18176/jiaci.0838. Epub 2022 Jun 22.

  PMID: 35735250 BACKGROUND

• Alfaya T, Vega A, Dominguez-Noche C, Ruiz B, Marques L, Sanchez-Morillas L. Longitudinal Validation of the Spanish Version of the Health-Related Quality of Life Questionnaire for Hymenoptera Venom Allergy (HRQLHA). J Investig Allergol Clin Immunol. 2015;25(6):426-30.

  PMID: 26817139 BACKGROUND

Related Links

• Comite de Alergia a Himenopteros. "Cuestionario de Calidad de Vida en Alérgicos a Himenópteros".

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum to perform immunological study of total IgE, serum tryptase, and specific IgE, IgG4, IgG1.

MeSH Terms

Conditions

Venom Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Arantza Vega Castro

  Hospital Universitario de Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Casanovas

CONTACT

+34 91208942; mcasanovas@inmunotek.com

Raquel Caballero

CONTACT

+34 607600638; rcaballero@inmunotek.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: January 24, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

ES (3)