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

Is the BAT Inhibition Able to Replace Sting Challenges?

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.

Study Overview

• Status: Recruiting
• Conditions: Vespid Venom Allergy
• Intervention / Treatment: Diagnostic test: sting challenge; Other: blood donation

• Study Type: Interventional
• Enrollment (Estimated): 219
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gunter J Sturm, MD, PhD; Phone Number: +4331638580318; Email: gunter.sturm@medunigraz.at
• Study Contact Backup: Name: Lisa Arzt-Gradwohl, PhD; Phone Number: +4331638578039; Email: lisa.arzt@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Department of Dermatology and Venerology, Medical University of Graz
    • Contact: Gunter J Sturm, MD, PhD; Phone Number: +4331638580318; Email: gunter.sturm@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: early maintenance phase; patients who reached the maintenance dose of venom immunotherapy one week (max. +3 weeks) before recruitment will be sting challenged	Diagnostic test: sting challenge; At the Moment, sting challenges are the only reliable method to identify patients who are not protected by insect venom immunotherapy.
Active Comparator: maintenance phase; patients who reached the maintenance dose of venom immunotherapy one year (+/- 2 months) before recruitment will be sting challenged	Diagnostic test: sting challenge; At the Moment, sting challenges are the only reliable method to identify patients who are not protected by insect venom immunotherapy.
Active Comparator: 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	Diagnostic test: sting challenge; At the Moment, sting challenges are the only reliable method to identify patients who are not protected by insect venom immunotherapy.
Other: blood donors; patients with confirmed vespid venom allergy who have not undergone venom immunotherapy (blood donation necessary to perform BAT Inhibition test)	Other: blood donation; To perform BAT Inhibition Tests, blood samples of patients with confirmed vespid venom allergy, who have not undergone venom immunotherapy, are necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Venom Hypersensitivity
• Other Study ID Numbers: 30-381 ex 17/18 (BATIRS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No