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

NCT04112797 | Unknown

• 1 other identifier: ROX-ALE-2018-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 8

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.

Conditions

Allergy to Himenoptera Venom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of vaccine evaluating re-sting test

  Result of the re-sting test

Interventions

Allergovac himenoptera BIOLOGICAL

Treatment with allergy vaccine againts Apis mellifera, Vespula spp or Polistes dominula

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with allergy to himenoptera venom.

You may qualify if:

• \. 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.
• \. Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice.
• \. 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.

You may not qualify if:

• Patients under treatment with immunotherapy against aeroallergens.
• 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.

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (8)

Hospital Vega Baja Orihuela

Orihuela, Alicante, 03314, Spain

RECRUITING

Hospital Mexoeiro

Vigo, Pontevedra, 36313, Spain

COMPLETED

C.H.U. A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Santa Maria

Lleida, 25198, Spain

RECRUITING

Hospital Fundación Alcorcón

Madrid, 28922, Spain

RECRUITING

Hospital Universitario Reina Sofia

Murcia, Spain

NOT YET RECRUITING

Hospital Joan XXIII

Tarragona, 43005, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, 46026, Spain

RECRUITING

Central Study Contacts

María Cruz Gómez, MP

CONTACT

+34 944438000; maricruz.gomez@roxall.es

Leire Begoña

CONTACT

+34 944438000; leire.begona@roxall.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: October 2, 2019
• Study Start: May 23, 2019
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

ES (8)