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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by University of Rostock.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947908
First Posted: July 28, 2009
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Rostock
  Purpose
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.

Condition Intervention
Hymenoptera Venom Allergy Biological: Hymenoptera venom

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • 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 Measures:
  • Surface molecule expression on myeloid DC and plasmacytoid DC [ Time Frame: Directly before, 1 hour after, and 12 months after initiation of immune therapy ]

Estimated Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947908


Locations
Germany
University of Rostock
Rostock, mecklenburg-Vorpommern, Germany, 18057
Sponsors and Collaborators
University of Rostock
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. Marek Lommatzsch, University of Rostock
ClinicalTrials.gov Identifier: NCT00947908     History of Changes
Other Study ID Numbers: LO-0004
First Submitted: July 27, 2009
First Posted: July 28, 2009
Last Update Posted: January 13, 2010
Last Verified: July 2009

Keywords provided by University of Rostock:
Hymenoptera venom allergy
Dendritic cells (DC)

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases