Allergy Insect Stinging, Allergy, Insect Venom, Insect Sting Allergy
Conditions
Keywords
Allergy, Immunotherapy, Apis mellifera, Vespula sp, controlled sting
Brief summary
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
BIOLOGICALVENOX
Treatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Sponsors
Inmunotek S.L.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.). | 12 months | Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 months | Registration of allergic reactions, spontaneous natural stings and a controlled sting test in participants sensitised to hymenoptera venom (Apis mellifera and/or Vespula spp.). |
| Immunological parameters of the participants after 12 months of treatment. | 12 months | 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. |
| SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom. | 12 months | 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. |
Countries
Spain
Contacts
Primary ContactMiguel Casanovas
Backup ContactRaquel Caballero
Outcome results
None listed