Study to Evaluate the Safety of Treatment With ALLERGOVAC® HIMENÓPTEROS in Patients Sensitized to This Venom

Study Overview
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Brief Summary
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It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.

Official Title
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Prospective Observational Study to Evaluate the Safety of Treatment With ALLERGOVAC® HIMENÓPTEROS in Patients Sensitized to This Venom

Conditions
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Allergy to Himenoptera Venom

Intervention / Treatment
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* Biological: Allergovac himenoptera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients over 14 years of age with allergy to bee venom, Polistes or Vespula. To meet this criteria, patients must present a systemic reaction with the bite of one of these insects, plus specific IgE detection in the skin test and / or IgE against the himenoptera venom. 2. Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice. 3. Patients who have given their written consent. In the case of minors, the assent will always be signed by the parent / legal guardian, in addition to the minor. Exclusion Criteria: Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study. Patients under treatment with immunotherapy against aeroallergens. Patients who have received previous treatment with immunotherapy, with any of the venoms that they are going to receive, in the 5 years prior to the inclusion in the study. Patients who under investigator opinion may present difficulties that prevent the comprehension of what was written in the information sheet for the patient, the informed consent or the completion of self-administered questionnaires. Patients who are participating in another clinical trial or observational study.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Allergovac himenoptera|Treatment with allergy vaccine againts Apis mellifera, Vespula spp or Polistes dominula|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by WAO classification | All adverse events ocurred during the study Will be collected and clasified following the WAO recommendations. The percentages Will be exposed by number of patients and by dose administrations. | During 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of vaccine evaluating re-sting test | Grade of treatment protection after controlled sting | Result of the re-sting test |