Hymenoptera AllergyMAISAVENNCT02295488
Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy
A study testing biological sampling and Desensitization protocol (Alyostall®) in people with Hymenoptera Allergy, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hymenoptera Allergy
- What is being tested?
- biological sampling and Desensitization protocol (Alyostall®)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2015to 12 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Conditions
- Hymenoptera Allergy
- Being tested
- biological sampling, Desensitization protocol (Alyostall®)
- Keywords
- hymenoptera puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplingProcedure or surgery
blood intake for biological sampling during validated desensitization protocol (Alyostall®)
Desensitization protocol (Alyostall®)Biological
Validated desensitization protocol using Alyostall® performed
| Study group | Role | What they receive |
|---|---|---|
| Desensitization | Experimental | Blood intake for biological sampling during validated desensitization protocol (Alyostall®) Receives: Procedure: biological sampling; Biological: Desensitization protocol (Alyostall®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 - 3h30
Secondary outcomes (2)
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®)
Measured: Day 1 - 5h30
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®)
Measured: Day 1 - 5h30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start23 Mar 2015
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hymenoptera AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc THIBERVILLE, Pr, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295488
- Sponsor's protocol ID
- 2014/069/HP
- Acronym
- MAISAVEN
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2014
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
L'ultrarush pendant l'immunothérapie aux venins d'hyménoptères conduit à une diminution les lymphocytes NK dans le sang - G.Mahay1J.Martinet2M.Roger3O.Boyer2L.Thiberville3 - 2017
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy
- ClinicalTrials.gov ID
- NCT02295488
- Acronym / sponsor ID
- MAISAVEN / 2014/069/HP
- Conditions
- Hymenoptera Allergy
- Keywords
- hymenoptera puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desensitization | Experimental | Procedure: biological sampling, Biological: Desensitization protocol (Alyostall®)Blood intake for biological sampling during validated desensitization protocol (Alyostall®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samplingblood intake for biological sampling during validated desensitization protocol (Alyostall®) | Procedure or surgery | Desensitization |
| Desensitization protocol (Alyostall®)Validated desensitization protocol using Alyostall® performed | Biological | Desensitization |
Primary outcome
Evolution of basophil activation test value
Time frame: Day 1 - 3h30
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
2 secondary outcomes
Correlation between results of activation basophil test results and tolerance
Time frame: Day 1 - 5h30
Evolution of basophil surface markers
Time frame: Day 1 - 5h30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publicationL'ultrarush pendant l'immunothérapie aux venins d'hyménoptères conduit à une diminution les lymphocytes NK dans le sang - G.Mahay1J.Martinet2M.Roger3O.Boyer2L.Thiberville3 - 2017
Related trials for Hymenoptera Allergy
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Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
Allergy, Insect Venom, Allergy Insect Stinging
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Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Allergy, Insect Venom, Allergy Insect Stinging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc THIBERVILLE, Pr principal investigator
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological sampling and Desensitization protocol (Alyostall®) in people with Hymenoptera Allergy, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of basophil activation test value (time frame: Day 1 - 3h30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.