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

NCT04438525 | Recruiting DMC

• 1 other identifier: 30-381 ex 17/18 (BATIRS)
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Outcome sting challenge vs. BAT Inhibition test

  The primary endpoint for the study is the inhibition of the CD63 basophil response (BAT inhibition at a concentration of 11ng/ml) in vespid venom allergic patients. A minimum activation of 25% is required to see sufficient inhibition of basophil activity. Immunotherapy will be considered successful if the BAT inhibition (with added serum) is reduced by at least 80% compared to 'no serum'.

  4 hours

Study Arms (4)

early maintenance phase

ACTIVE COMPARATOR

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

Diagnostic Test: sting challenge

maintenance phase

ACTIVE COMPARATOR

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

Diagnostic Test: sting challenge

after stopping VIT

ACTIVE COMPARATOR

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

Diagnostic Test: sting challenge

blood donors

OTHER

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

Other: blood donation

Interventions

sting challenge 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; early maintenance phase; maintenance phase

blood donation OTHER

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

blood donors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Dermatology and Venerology, Medical University of Graz

Graz, 8036, Austria

RECRUITING

MeSH Terms

Interventions

Blood Donation

Intervention Hierarchy (Ancestors)

Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Gunter J Sturm, MD, PhD

CONTACT

+4331638580318; gunter.sturm@medunigraz.at

Lisa Arzt-Gradwohl, PhD

CONTACT

+4331638578039; lisa.arzt@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 19, 2020
• Study Start: January 7, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)