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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-23

Study Completion Date

2018-04-12

Brief Summary

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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

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Detailed Description

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Conditions

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Hymenoptera Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Desensitization

Blood intake for biological sampling during validated desensitization protocol (Alyostall®)

Group Type EXPERIMENTAL

biological sampling

Intervention Type PROCEDURE

blood intake for biological sampling during validated desensitization protocol (Alyostall®)

Desensitization protocol (Alyostall®)

Intervention Type BIOLOGICAL

Validated desensitization protocol using Alyostall® performed

Interventions

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biological sampling

blood intake for biological sampling during validated desensitization protocol (Alyostall®)

Intervention Type PROCEDURE

Desensitization protocol (Alyostall®)

Validated desensitization protocol using Alyostall® performed

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No