Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy

Not Applicable

Completed

• Conditions: Hymenoptera Allergy
• Interventions: Procedure: biological sampling; Biological: Desensitization protocol (Alyostall®)

• Registration Number: NCT02295488
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a very rapid increase in doses of venom extracts administered during the SIT in a day without systemic reaction of the patient which is not yet explained. The hypothesis is that this good tolerance is due to a rapid decrease in the response of mast cells and basophils to the allergen..

The main objective is to study basophil activation in response to the allergen during the first day of desensitization, measured by basophil activation test.

The initiation of desensitization follow a protocol of rapid growth rates. The basophil activation level in the course of desensitization will be analyzed by flow cytometry after in vitro stimulation by allergen.

Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the expression of different proteins in blood basophils will be studied by measuring their messenger RNAs

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Study Start: 2015-03-23
• Primary Completion: 2018-04-12
• Study Completion: 2018-04-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Patients over 18 years and below 75 years age
• Patient who presented a generalized allergic reaction after an puncture of a hymenoptera
• Patient with positive skin tests against the venom of a hymenoptera
• Patient with positive specific IgE against the venom of a hymenoptera • to which an indication of accelerated desensitization was chosen in day hospitalization
• Information and consent signed by the patient
• Patient affiliated to french social security system
• For women of childbearing age, taking an effective contraceptive.

Exclusion Criteria

• Patients with the following diseases: Mastocytosis, systemic infection or hospitalization within 4 weeks before inclusion, chronic inflammatory disease, cancer, unbalanced asthma, immune deficiency
• Patients on beta-blocker, following another specific immunotherapy, or ongoing immunosuppressive therapy.
• Pregnant or lactating
• People placed under judicial protection
• Patient participating or having participated in another biomedical research within six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Desensitization	biological sampling	Blood intake for biological sampling during validated desensitization protocol (Alyostall®)
Desensitization	Desensitization protocol (Alyostall®)	Blood intake for biological sampling during validated desensitization protocol (Alyostall®)

Primary Outcome Measures

Name	Time	Method
Evolution of basophil activation test value	Day 1 - 3h30	Evolution of the basophil activation test (% of activated basophils) between the morning before the start of desensitization (Alyostall®) and before the last dose of the first day

Secondary Outcome Measures

Name	Time	Method
Evolution of basophil surface markers	Day 1 - 5h30	Evolution of activated basophil surface markers by cytometric flow (% of activated) between the start of desensitization and before the last injection of the fist day of desensitization (Alyostall®)
Correlation between results of activation basophil test results and tolerance	Day 1 - 5h30	Looking for a correlation between the results of activation basophil test (% of activated basophils) and tolerance on the one hand and on the other hand the effectiveness of clinically evaluated desensitization (Alyostall®)

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France