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

January 12, 2010 updated by: University of Rostock
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • mecklenburg-Vorpommern
      • Rostock, mecklenburg-Vorpommern, Germany, 18057
        • University of Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Directly before, 1 hour after, and 12 months after initiation of immune therapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LO-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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