Clinical trial NCT04112797: Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
Official title: Prospective Observational Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergy to Himenoptera Venom
Lead sponsor: Roxall Medicina España S.A
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with allergy to himenoptera venom.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by WAO classification
timeFrame: During 1 year
Secondary outcomes:
measure: Efficacy of vaccine evaluating re-sting test
timeFrame: Result of the re-sting test
Other outcomes:
Locations:
city: Orihuela
country: Spain
facility: Hospital Vega Baja Orihuela
state: Alicante
city: Vigo
country: Spain
facility: Hospital Mexoeiro
state: Pontevedra
city: A Coruña
country: Spain
facility: C.H.U. A Coruña
city: Lleida
country: Spain
facility: Hospital Santa Maria
city: Madrid
country: Spain
facility: Hospital Fundación Alcorcón
city: Murcia
country: Spain
facility: Hospital Universitario Reina Sofia
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
References: