Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
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 →
Overview
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.
Interventions
- Biological VENOX
Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Primary outcome measures
- 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. [Time frame: 12 months]
Secondary outcome measures (3)
- Evaluation of the immunogenicity of the participant after 6 and 12 months of treatment. [Time frame: 12 months]
- Quality of life in treated participants after 6 and 12 months of treatment. [Time frame: 12 months]
- 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. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
- Age equal to or older than 14 years, without gender differences.
- Not having received immunotherapy with hymenoptera venom in the previous 5 years.
- 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
- 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 the medical indications or do not show cooperation with respect to the immunotherapy treatment.
- Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive treatment.
- Participants in whom the administration of immunotherapy is contraindicated.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 9 centers
- Hospital Arquitecto Marcide — Ferrol
- Hospital Virgen del Puerto Plasencia — Plasencia
- Hospital Público Da Mariña — Burela de Cabo
- Hospital Comarcal de Monforte de Lemos — Monforte de Lemos
- Hospital de A Coruña — A Coruña
- Hospital Vall d' Hebron — Barcelona
- Hospital Universitario Lucus Augusti — Lugo
- Complejo Hospitalario Universitario de Ourense — Ourense
- … and 1 more center
Publications
- Oude Elberink JN, De Monchy JG, Van Der Heide S, Guyatt GH, Dubois AE. Venom immunotherapy improves health-related quality of life in patients allergic to yellow jacket venom. J Allergy Clin Immunol. 2002 Jul;110(1):174-82. doi: 10.1067/mai.2002.125827. PMID 12110838
- Golden DB. Insect sting allergy and venom immunotherapy: a model and a mystery. J Allergy Clin Immunol. 2005 Mar;115(3):439-47; quiz 448. doi: 10.1016/j.jaci.2005.01.005. PMID 15753884
- Bousquet J, Muller UR, Dreborg S, Jarisch R, Malling HJ, Mosbech H, Urbanek R, Youlten L. Immunotherapy with Hymenoptera venoms. Position paper of the Working Group on Immunotherapy of the European Academy of Allergy and Clinical Immunology. Allergy. 1987 Aug;42(6):401-13. doi: 10.1111/j.1398-9995.1987.tb00355.x. PMID 3310714
- Demsar Luzar A, Korosec P, Kosnik M, Zidarn M, Rijavec M. Hymenoptera Venom Immunotherapy: Immune Mechanisms of Induced Protection and Tolerance. Cells. 2021 Jun 22;10(7):1575. doi: 10.3390/cells10071575. PMID 34206562
Identifiers
NCT: NCT06782217 · ITK-VENOX-2024-01