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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02295488
Acronym
MAISAVEN
Enrollment
29
Registered
2014-11-20
Start date
2015-03-23
Completion date
2018-04-12
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hymenoptera Allergy

Keywords

hymenoptera puncture

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

Interventions

PROCEDUREbiological sampling

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

BIOLOGICALDesensitization protocol (Alyostall®)

Validated desensitization protocol using Alyostall® performed

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of basophil activation test valueDay 1 - 3h30Evolution 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

MeasureTime frameDescription
Correlation between results of activation basophil test results and toleranceDay 1 - 5h30Looking 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 markersDay 1 - 5h30Evolution 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®)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORLuc THIBERVILLE, Pr

UH Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026