Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom

• Conditions: Allergy to Himenoptera Venom

• Registration Number: NCT04112797
• Lead Sponsor: Roxall Medicina España S.A

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

1. Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study.
2. Patients under treatment with immunotherapy against aeroallergens.
3. 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.
4. 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.
5. Patients who are participating in another clinical trial or observational study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by WAO classification	During 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of vaccine evaluating re-sting test	Result of the re-sting test	Grade of treatment protection after controlled sting

Trial Locations

Locations (8)

C.H.U. A Coruña; 🇪🇸 A Coruña, Spain

Hospital Fundación Alcorcón; 🇪🇸 Madrid, Spain

Hospital Santa Maria; 🇪🇸 Lleida, Spain

Hospital Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Murcia, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Hospital Mexoeiro; 🇪🇸 Vigo, Pontevedra, Spain

Hospital Vega Baja Orihuela; 🇪🇸 Orihuela, Alicante, Spain