RecruitingNot ApplicableNCT04438525

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

Is the BAT Inhibition Able to Replace Sting Challenges?


Sponsor

Medical University of Graz

Enrollment

219 participants

Start Date

Jan 7, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a laboratory test called the Basophil Activation Test (BAT) can replace the standard sting challenge test for patients who have received venom immunotherapy (allergy shots) for wasp or bee sting allergies. Sting challenges — where the patient is deliberately stung under medical supervision — are the gold standard for checking if immunotherapy has worked, but they are stressful, risky, and time-consuming. The BAT is a blood test that measures immune cell reactivity, and researchers believe it may be able to tell whether immunotherapy has been effective without actually stinging the patient. Participants are adults who are undergoing or have completed venom immunotherapy. They have both tests done and the results are compared to see how well BAT predicts the outcome of the sting challenge. You may be eligible if: - You are between 18 and 70 years old - You are currently being treated or have been treated with venom immunotherapy for wasp/bee sting allergy - You have given written informed consent You may NOT be eligible if: - You are pregnant - You have an autoimmune disease - You have uncontrolled cardiovascular disease - You have uncontrolled asthma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTsting challenge

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

OTHERblood donation

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


Locations(1)

Department of Dermatology and Venerology, Medical University of Graz

Graz, Austria

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NCT04438525