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

U

University Hospital, Rouen

Status

Completed

Conditions

Hymenoptera Allergy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02295488
2014/069/HP

Details and patient eligibility

About

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

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

29 participants in 1 patient group

Desensitization
Experimental group
Description:
Blood intake for biological sampling during validated desensitization protocol (Alyostall®)
Treatment:
Procedure: biological sampling
Biological: Desensitization protocol (Alyostall®)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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