Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VENOX.
- Who it may be relevant to
- Registry conditions: Allergy, Insect Venom, Allergy Insect Stinging, Insect Sting Allergy. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Overview
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.
Detailed description
Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.
Interventions
- Biological VENOX
Treatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Primary outcome measures
- Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.). [Time frame: 12 months]
Secondary outcome measures (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. [Time frame: 12 months]
- Immunological parameters of the participants after 12 months of treatment. [Time frame: 12 months]
- SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Spain · 3 centers
- Hospital Universitario Fundación Alcorcón — Alcorcón
- Hospital Reina Sofía — Córdoba
- Hospital Universitario de Guadalajara — Guadalajara
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT06790368 · ITK-VENOX-2023-01