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

NCT00947908 | Unknown

• 1 other identifier: LO-0004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hymenoptera Venom Allergy

Keywords

Hymenoptera venom allergy; Dendritic cells (DC)

Outcome Measures

Primary Outcomes (1)

• Number of myeloid DC and plasmacytoid DC in peripheral blood

  Directly before, 1 hour after, and 12 months after initiation of immune therapy

Secondary Outcomes (1)

• Surface molecule expression on myeloid DC and plasmacytoid DC

  Directly before, 1 hour after, and 12 months after initiation of immune therapy

Study Arms (1)

A

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).

Biological: Hymenoptera venom

Interventions

Hymenoptera venom BIOLOGICAL

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).

A

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosed hymenoptera venom allergy
• No previous treatments for hymenoptera venom allergy

You may not qualify if:

• Treatment with immunosuppressive agents
• Any malignant disease
• Infections within 1 week prior to the initiation of the treatment

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Related Publications (2)

• 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.

  PMID: 16928719 BACKGROUND

• 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.

  PMID: 21281873 DERIVED

MeSH Terms

Interventions

Arthropod Venoms

Intervention Hierarchy (Ancestors)

Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 13, 2010

Record last verified: 2009-07

Locations

DE (1)