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

NCT04259359 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 266

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

  • Bee Venom Allergy

Interventions

DRUG

Insect 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.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Austria
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04259359 on ClinicalTrials.gov