Back to resultsRegulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
Primary Purpose
Hymenoptera Venom Allergy
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hymenoptera venom
Sponsored by
About this trial
This is an interventional basic science trial for Hymenoptera Venom Allergy focused on measuring Hymenoptera venom allergy, Dendritic cells (DC)
Eligibility Criteria
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
Sites / Locations
- University of Rostock
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
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).
Outcomes
Primary Outcome Measures
Number of myeloid DC and plasmacytoid DC in peripheral blood
Secondary Outcome Measures
Surface molecule expression on myeloid DC and plasmacytoid DC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00947908
Brief Title
Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
Official Title
Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Rostock
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hymenoptera Venom Allergy
Keywords
Hymenoptera venom allergy, Dendritic cells (DC)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Hymenoptera venom
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of myeloid DC and plasmacytoid DC in peripheral blood
Time Frame
Directly before, 1 hour after, and 12 months after initiation of immune therapy
Secondary Outcome Measure Information:
Title
Surface molecule expression on myeloid DC and plasmacytoid DC
Time Frame
Directly before, 1 hour after, and 12 months after initiation of immune therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Rostock
City
Rostock
State/Province
mecklenburg-Vorpommern
ZIP/Postal Code
18057
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16928719
Citation
Bratke K, Lommatzsch M, Julius P, Kuepper M, Kleine HD, Luttmann W, Christian Virchow J. Dendritic cell subsets in human bronchoalveolar lavage fluid after segmental allergen challenge. Thorax. 2007 Feb;62(2):168-75. doi: 10.1136/thx.2006.067793. Epub 2006 Aug 23.
Results Reference
background
PubMed Identifier
21281873
Citation
Dreschler K, Bratke K, Petermann S, Bier A, Thamm P, Kuepper M, Virchow JC, Lommatzsch M. Impact of immunotherapy on blood dendritic cells in patients with Hymenoptera venom allergy. J Allergy Clin Immunol. 2011 Feb;127(2):487-494.e1-3. doi: 10.1016/j.jaci.2010.12.003.
Results Reference
derived
Learn more about this trial
Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
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