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NCT02295488: MAISAVEN

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

Completed NA Last updated 25 October 2019
What this trial tests

NA trial testing biological sampling in Hymenoptera Allergy in 29 participants. Completed in 12 April 2018.

Timeline
23 March 2015
Primary endpoint
12 April 2018
12 April 2018

Quick facts

Lead sponsorUniversity Hospital, Rouen
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment29
Start date23 March 2015
Primary completion12 April 2018
Estimated completion12 April 2018
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Rouen

Who can join

18 and older, any sex, with Hymenoptera Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Adjuvants for allergy immunotherapeutics.
    Gamazo C, D'Amelio C, Gastaminza G, Ferrer M, et al · · 2017 · cited 25× · PMID 28825867 · DOI 10.1080/21645515.2017.1348447

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Other trials of biological sampling

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