Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy (NCT02295488) | Clinical Trial Compass
CompletedNot Applicable
Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy
France29 participantsStarted 2015-03-23
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.