RecruitingNCT04259359

Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure


Sponsor

Medical University of Graz

Enrollment

266 participants

Start Date

May 2, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

Venom immunotherapy (VIT) is an established treatment for Hymenoptera venom allergy and provides long-term protection from further generalized reactions in almost all patients. However, it is still unclear why bee VIT is less effective than vespid VIT. The preliminary data show that not only predominant Api m 10 sensitization but also other predominant sensitizations may be relevant as risk factors for treatment failure. Interestingly, all patients with a predominant Api m 10 sensitization who received bee VIT with a venom preparation with a supposed lack of Api m 10 tolerated sting challenges. Therefore, a multicenter study with a sufficient number of patients with treatment failure is urgently required, to clarify if predominant sensitization to a bee venom allergen is a risk factor for treatment failure. If predominant sensitization is a risk factor and caused by underrepresented components in bee venom preparations used for VIT, bee venom preparations may be optimized in the future and patients would benefit from a more effective VIT.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • Legally competent male and female subjects aged from 18 to 70 years with a history of a systemic anaphylactic sting reaction (≥ grade I according to the classification of Ring and Messmer) after bee stings, who will receive bee venom immunotherapy

Exclusion Criteria1

  • Contraindications to VIT

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGInsect Venom

Patients will be treated with bee venom immunotherapy (protocol can be selected by patient). Blood samples are taken before starting VIT to determine specific immunoglobulin E (sIgE) Levels for bee venom components. Patients are sting challenged and the outcome will be recorded.


Locations(3)

Department of Dermatology and Venerology, Medical University of Graz

Graz, Austria

Elbe Klinikum Buxtehude

Buxtehude, Germany

Hospital Universitario de Castellón

Castellon, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04259359