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

Allergy to Himenoptera Venom Clinical Trial

— HIPNOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04112797
• Other study ID #: ROX-ALE-2018-02
• Status: Recruiting
• Start date: May 23, 2019
• Est. completion date: November 2023

Study information

• Verified date: March 2022
• Source: Roxall Medicina España S.A
• Contact: María Cruz Gómez, MP
• Phone: +34 944438000
• Email: maricruz.gomez[@]roxall.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergy to Himenoptera Venom

Intervention

Biological:
• Allergovac himenoptera
Treatment with allergy vaccine againts Apis mellifera, Vespula spp or Polistes dominula

Locations

Country	Name	City	State
Spain	C.H.U. A Coruña	A Coruña
Spain	Hospital Santa Maria	Lleida
Spain	Hospital Fundación Alcorcón	Madrid
Spain	Hospital Universitario Reina Sofia	Murcia
Spain	Hospital Vega Baja Orihuela	Orihuela	Alicante
Spain	Hospital Joan XXIII	Tarragona
Spain	Hospital Universitario La Fe	Valencia
Spain	Hospital Mexoeiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Roxall Medicina España S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy of vaccine evaluating re-sting test	Grade of treatment protection after controlled sting	Result of the re-sting test