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

Medical University of Graz

Status: Enrolling

Conditions: Bee Venom Allergy

Treatments: Drug: Insect Venom

Study type: Observational

Funder types: Other

Identifiers

NCT04259359

31-238 ex 18/19 (PREDICT)

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Contraindications to VIT

Trial design

266 participants in 1 patient group

patients who will be treated with bee venom immunotherapy

Treatment:

Drug: Insect Venom