Gene expression analysis elucidating pathogenic mechanisms and predicting vespid venom anaphylaxis

Completed

• Conditions: Vespid venom allergy; wasp venom allergy; 10001708

• Registration Number: NL-OMON38535
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* A clear positive history of a systemic response grade II, III or IVa after a vespid sting
* Vespid specific serum IgE > 0.35 kUA/l or a positive intracutaneous skin test for vespid venom (at <= 1 µg/ml a histamine equivalent prick of >=0.7)
written informed consent

Exclusion Criteria

* A positive history of a systemic response grade IVb according to Mueller (13) after a vespid sting
* Age under 18 years or above 65 years
* Incapacitated subjects
* Severe cardiopulmonary disease (clinical evidence of congestive heart failure, coronary disease or severe hypertension)
* Insufficiently controlled asthma based on history, asthma control questionnaire and if the observed FEV1 is 70% of predicted.
* Conditions that influence the immune system (immune deficiencies, malignancy, auto-immune diseases, flulike dissease)
* Severe kidney failure
* Interfering medication with the outcome or recovery from a systemic reaction (β-blockers and immunosuppressive drugs)
* Pregnancy(measured before inclusion by β-hCG)
* Mastocytosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter: Genes for which the expression is significantly different<br /><br>between reactors and non-reactors based on a log2 fold change > 2 in gene<br /><br>expression, identify the corresponding functional annotation and building a<br /><br>corresponding naïve Bayes prediction model to identify patients at risk for a<br /><br>re-systemic reaction. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameter: Genes for which the expression after the sting<br /><br>challenge is significantly different compared to base line expression levels<br /><br>and identify the corresponding functional annotation.</p><br>