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

NCT02295488 | Completed

• 1 other identifier: 2014/069/HP
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Hymenoptera Allergy

Keywords

hymenoptera puncture

Outcome Measures

Primary Outcomes (1)

• Evolution of basophil activation test value

  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

  Day 1 - 3h30

Secondary Outcomes (2)

• Correlation between results of activation basophil test results and tolerance

  Day 1 - 5h30

• Evolution of basophil surface markers

  Day 1 - 5h30

Study Arms (1)

Desensitization

EXPERIMENTAL

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

Procedure: biological sampling; Biological: Desensitization protocol (Alyostall®)

Interventions

biological sampling PROCEDURE

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

Desensitization

Desensitization protocol (Alyostall®) BIOLOGICAL

Validated desensitization protocol using Alyostall® performed

Desensitization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Study Officials

• Luc THIBERVILLE, Pr

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 20, 2014
• Study Start: March 23, 2015
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

FR (1)