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

Primary Purpose

Hymenoptera Allergy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological sampling
Desensitization protocol (Alyostall®)
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hymenoptera Allergy focused on measuring hymenoptera puncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Desensitization

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correlation between results of activation basophil test results and tolerance
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
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®)

Full Information

First Posted
October 21, 2014
Last Updated
October 23, 2019
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02295488
Brief Title
Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy
Acronym
MAISAVEN
Official Title
Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2015 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
April 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hymenoptera Allergy
Keywords
hymenoptera puncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desensitization
Arm Type
Experimental
Arm Description
Blood intake for biological sampling during validated desensitization protocol (Alyostall®)
Intervention Type
Procedure
Intervention Name(s)
biological sampling
Intervention Description
blood intake for biological sampling during validated desensitization protocol (Alyostall®)
Intervention Type
Biological
Intervention Name(s)
Desensitization protocol (Alyostall®)
Intervention Description
Validated desensitization protocol using Alyostall® performed
Primary Outcome Measure Information:
Title
Evolution of basophil activation test value
Description
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
Time Frame
Day 1 - 3h30
Secondary Outcome Measure Information:
Title
Correlation between results of activation basophil test results and tolerance
Description
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®)
Time Frame
Day 1 - 5h30
Title
Evolution of basophil surface markers
Description
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®)
Time Frame
Day 1 - 5h30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc THIBERVILLE, Pr
Organizational Affiliation
UH Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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