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

Hymenoptera Venom Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00947908
• Other study ID #: LO-0004
• Status: Active, not recruiting
• Phase: N/A
• First received: July 27, 2009
• Last updated: January 12, 2010
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: July 2009
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hymenoptera Venom Allergy
• Hypersensitivity

Intervention

Biological:
• Hymenoptera venom
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).

Locations

Country	Name	City	State
Germany	University of Rostock	Rostock	mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Epub 2006 Aug 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of myeloid DC and plasmacytoid DC in peripheral blood		Directly before, 1 hour after, and 12 months after initiation of immune therapy	No
Secondary	Surface molecule expression on myeloid DC and plasmacytoid DC		Directly before, 1 hour after, and 12 months after initiation of immune therapy	No