Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy

Study Overview
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Brief Summary
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Dendritic cells (DC) play a key role in the pathogenesis of allergic diseases. The regulation of blood dendritic cells in patients with hymenoptera venom allergy before and during immune therapy is unknown.

Official Title
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Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy

Conditions
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Hymenoptera Venom Allergy

Intervention / Treatment
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* Biological: Hymenoptera venom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosed hymenoptera venom allergy No previous treatments for hymenoptera venom allergy Exclusion Criteria: Treatment with immunosuppressive agents Any malignant disease Infections within 1 week prior to the initiation of the treatment

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Patients are treated with hymenoptera (bee or wasp) venom using subcutaneous injections. The initiation of immune therapy consists of a 52-hour-period in which patients are treated with increasing doses of hymenoptera venom. Afterwards, patients are treated with monthly subcutaneous injections with a fixed dose of hymenoptera venom. Blood will be collected directly before and 1 hour after initiation of immune therapy and after 12 months of immune therapy (directly before the next subcutaneous injection of hymenoptera venom). | Biological: Hymenoptera venom<br>* Patients are treated with hymenoptera (bee or wasp) venom using subcutaneous injections. The initiation of immune therapy consists of a 52-hour-period in which patients are treated with increasing doses of hymenoptera venom. Afterwards, patients are treated with monthly subcutaneous injections with a fixed dose of hymenoptera venom. Blood will be collected directly before and 1 hour after initiation of immune therapy and after 12 months of immune therapy (directly before the next subcutaneous injection of hymenoptera venom).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of myeloid DC and plasmacytoid DC in peripheral blood |  | Directly before, 1 hour after, and 12 months after initiation of immune therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface molecule expression on myeloid DC and plasmacytoid DC |  | Directly before, 1 hour after, and 12 months after initiation of immune therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hymenoptera venom allergy, Dendritic cells (DC)