Clinical trial NCT04259359: Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure
Official title: Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bee Venom Allergy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will be treated with bee venom immunotherapy

Brief 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 criteria: 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

Primary outcomes:
measure: The primary objective of the study is to evaluate whether predominant sensitization to Api m 10 is a risk factor for treatment failure.
timeFrame: depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose
Secondary outcomes:
measure: To evaluate if predominant sensitization to either Api m 1, Api m 2, Api m 3 or Api m 5 is a risk factor for treatment failure.
timeFrame: depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose
measure: To evaluate if low immunoglobulin G4 (IgG4) levels to bee venom or to Api m 1, Api m 2, Api m 3, Api m 5, or Api m 10 after VIT is a risk factor for treatment failure.
timeFrame: depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose
measure: To evaluate if systemic side effects are a risk factor for treatment failure.
timeFrame: depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose
measure: To evaluate if antihypertensive medication is a risk factor for treatment failure.
timeFrame: depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Dermatology and Venerology, Medical University of Graz
Study officials:
References: