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.
Study Type
OBSERVATIONAL
Enrollment
120
Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain
NOT_YET_RECRUITINGHospital Virgen del Puerto Plasencia
Plasencia, Cáceres, Spain
RECRUITINGHospital Público Da Mariña
Burela de Cabo, Lugo, Spain
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).
Time frame: 12 months
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.
Time frame: 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.
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.
Registration of allergic reactions after spontaneous natural stings.
Time frame: 12 months
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Hospital Comarcal de Monforte de Lemos
Monforte de Lemos, Lugo, Spain
RECRUITINGHospital de A Coruña
A Coruña, Spain
RECRUITINGHospital Vall d' Hebron
Barcelona, Spain
RECRUITINGHospital Universitario Lucus Augusti
Lugo, Spain
RECRUITINGComplejo Hospitalario Universitario de Ourense
Ourense, Spain
RECRUITINGHospital Universitario de Pontevedra
Pontevedra, Spain
RECRUITING