Is the BAT Inhibition Able to Replace Sting Challenges? (BATIRS)

NCT ID: NCT04438525

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2026-12-31

Brief Summary

Insect venom allergy is the major cause for severe allergic reactions in Europe. Wasps and honeybees are responsible for the majority of these allergic reactions. Symptoms range from generalized skin symptoms (wheals, swellings) to respiratory or cardiovascular problems such as asthma, dizziness, loss of consciousness, or cardiac arrest. The regular administration of insect venom ('venom immunotherapy') over up to 5 years is a well-established therapy, providing long-term protection from further systemic sting reactions in the majority of patients. However, there is no laboratory test which is able to identify patients who will still react to an insect sting. The only reliable method available is stinging patients with living insects ('sting challenges'). The key issue is that only few centers in Europe perform sting challenges and many patients have no access to these tests. Therefore, it is of utmost importance to find a method which is able to identify patients who are still at risk for future allergic sting reactions.

The inhibition of the basophil activation test (BAT) could be a potential method to monitor the effectiveness of immunotherapy. Basophils are cells which are activated in acute allergic reactions. The basophil activation of blood donors with vespid venom allergy can be measured after adding sera from allergic patients undergoing immunotherapy. In a preliminary study we found that the activation of basophils could be inhibited in all patients treated with vespid venom, however, results must be confirmed in a larger study.

In this study, a total of 219 patients with vespid venom allergy will be included. Those patients who are receiving or who have already finished venom immunotherapy will be sting challenged and blood samples will be taken to perform BAT inhibition experiments. At the same time, donors with confirmed vespid venom allergy, who have not undergone immunotherapy, will be recruited for a blood donation, which is necessary for the BAT inhibition tests.

If results of the preliminary study could be confirmed, the BAT inhibition will facilitate monitoring the effectiveness of venom immunotherapy and patients would benefit from an early detection of lacking tolerance and consequently from the increased venom dose preventing future life threatening systemic sting reactions.

Conditions

Vespid Venom Allergy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

early maintenance phase

patients who reached the maintenance dose of venom immunotherapy one week (max. +3 weeks) before recruitment will be sting challenged

Group Type: ACTIVE_COMPARATOR

sting challenge

Intervention Type: DIAGNOSTIC_TEST

At the Moment, sting challenges are the only reliable method to identify patients who are not protected by insect venom immunotherapy.

maintenance phase

patients who reached the maintenance dose of venom immunotherapy one year (+/- 2 months) before recruitment will be sting challenged

Group Type: ACTIVE_COMPARATOR

sting challenge

Intervention Type: DIAGNOSTIC_TEST

At the Moment, sting challenges are the only reliable method to identify patients who are not protected by insect venom immunotherapy.

after stopping VIT

patients who finished venom immunotherapy two years (+/- 6 months) before recruitment (duration of VIT: at least 3 years) will be sting challenged

Group Type: ACTIVE_COMPARATOR

sting challenge

Intervention Type: DIAGNOSTIC_TEST

At the Moment, sting challenges are the only reliable method to identify patients who are not protected by insect venom immunotherapy.

blood donors

patients with confirmed vespid venom allergy who have not undergone venom immunotherapy (blood donation necessary to perform BAT Inhibition test)

Group Type: OTHER

blood donation

Intervention Type: OTHER

To perform BAT Inhibition Tests, blood samples of patients with confirmed vespid venom allergy, who have not undergone venom immunotherapy, are necessary.

Interventions

sting challenge

At the Moment, sting challenges are the only reliable method to identify patients who are not protected by insect venom immunotherapy.

Intervention Type: DIAGNOSTIC_TEST

blood donation

To perform BAT Inhibition Tests, blood samples of patients with confirmed vespid venom allergy, who have not undergone venom immunotherapy, are necessary.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Legally competent male and female subjects who are currently treated or who have been treated with vespid venom immunotherapy
• Age ≥18 and ≤70 years
• Written consent of the participant after being informed

Exclusion Criteria

• Pregnancy
• Autoimmune disease
• Uncontrolled cardiovascular disease
• Uncontrolled asthma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Dermatology and Venerology, Medical University of Graz

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Gunter J Sturm, MD, PhD

Role: CONTACT

gunter.sturm@medunigraz.at

+4331638580318

Lisa Arzt-Gradwohl, PhD

Role: CONTACT

lisa.arzt@medunigraz.at

+4331638578039

Facility Contacts

Gunter J Sturm, MD, PhD

Role: primary

gunter.sturm@medunigraz.at

+4331638580318

Other Identifiers

30-381 ex 17/18 (BATIRS)

Identifier Type: -

Identifier Source: org_study_id