Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy (MAISAVEN)

May 12, 2026 updated by: University Hospital, Rouen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desensitization
Blood intake for biological sampling during validated desensitization protocol (Alyostall®)
Procedure: biological sampling
blood intake for biological sampling during validated desensitization protocol (Alyostall®)
Biological: Desensitization protocol (Alyostall®)
Validated desensitization protocol using Alyostall® performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of basophil activation test value
Time Frame: 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
Day 1 - 3h30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between results of activation basophil test results and tolerance
Time Frame: 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®)
Day 1 - 5h30
Evolution of basophil surface markers
Time Frame: 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®)
Day 1 - 5h30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Luc THIBERVILLE, Pr, UH Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • L'ultrarush pendant l'immunothérapie aux venins d'hyménoptères conduit à une diminution les lymphocytes NK dans le sang - G.Mahay1J.Martinet2M.Roger3O.Boyer2L.Thiberville3 - 2017

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2015

Primary Completion (Actual)

April 12, 2018

Study Completion (Actual)

April 12, 2018

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimated)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/069/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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