Completed

NCT Number: NCT02295488

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hymenoptera Allergy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological sampling

Procedure

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

Desensitization protocol (Alyostall®)

Biological

Validated desensitization protocol using Alyostall® performed

Primary outcomes

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

Secondary outcomes

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®)
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®)

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: MAISAVEN

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Nov 20, 2014
Registry last updated: May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.