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.
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.
Study Type
OBSERVATIONAL
Enrollment
80
Treatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
RECRUITINGHospital Reina Sofía
Córdoba, Spain
RECRUITINGHospital Universitario de Guadalajara
Guadalajara, Spain
RECRUITINGIncidence 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).
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 stings during the 1-year follow-up.
Registration of allergic reactions, spontaneous natural stings and a controlled sting test in participants sensitised to hymenoptera venom (Apis mellifera and/or Vespula spp.).
Time frame: 12 months
Immunological parameters of the participants after 12 months of treatment.
Immunological study: total IgE, 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 site 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
SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.
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 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, with 1 indicating the worst quality of life and 7 the best.
Time frame: 12 months
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