Overview

This trial is active, not recruiting.

Condition hymenoptera venom allergy
Treatment hymenoptera venom
Sponsor University of Rostock
Start date June 2009
End date June 2010
Trial size 20 participants
Trial identifier NCT00947908, LO-0004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
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).
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).

Primary Outcomes

Measure
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 Outcomes

Measure
Surface molecule expression on myeloid DC and plasmacytoid DC
time frame: Directly before, 1 hour after, and 12 months after initiation of immune therapy

Eligibility Criteria

Male or female participants from 16 years up to 80 years old.

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

Additional Information

Official title Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by University of Rostock.