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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients allergic to hymenoptera venom | Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX immunotherapy (ATC code: V01AA07). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VENOX | Biological | Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the immunogenicity of the participant after 6 and 12 months of treatment. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants aged 14 years and older diagnosed with allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive immunotherapy wit himenoptera venom according to standard clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Casanovas, MD | Contact | +3491208942 | mcasanovas@inmunotek.com | |
| Raquel Caballero, BSc | Contact | +34607600638 | rcaballero@inmunotek.com |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Javier Carballada, MD | Hospital Universitario Lucus Augusti | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Arquitecto Marcide | Not yet recruiting | Ferrol | A Coruña | 15405 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12110838 | Background | 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. | |
| 15753884 | Background | 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. |
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Blood serum to perform immunological study of total IgE, and specific IgE, IgG4, IgG1.
| 12 months |
| Quality of life in treated participants after 6 and 12 months of treatment. | 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. | 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. | Registration of allergic reactions after spontaneous natural stings. | 12 months |
| Hospital Virgen del Puerto Plasencia | Recruiting | Plasencia | Cáceres | 10600 | Spain |
|
| Hospital Público Da Mariña | Recruiting | Burela de Cabo | Lugo | 27880 | Spain |
|
| Hospital Comarcal de Monforte de Lemos | Recruiting | Monforte de Lemos | Lugo | 27400 | Spain |
|
| Hospital de A Coruña | Recruiting | A Coruña | 15006 | Spain |
|
| Hospital Vall d' Hebron | Recruiting | Barcelona | 08035 | Spain |
|
| Hospital Universitario Lucus Augusti | Recruiting | Lugo | 27003 | Spain |
|
| Complejo Hospitalario Universitario de Ourense | Recruiting | Ourense | 32005 | Spain |
|
| Hospital Universitario de Pontevedra | Recruiting | Pontevedra | 36071 | Spain |
|
| 3310714 | Background | 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. |
| 34206562 | Background | 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. |
| ID | Term |
|---|---|
| D000092422 | Venom Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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