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Maintenance Bee-Venom Immunotherapy Administered at 6-Month Intervals Does Not Protect Against re-Stings

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684476
First Posted: May 26, 2008
Last Update Posted: May 26, 2008
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:
Meir Medical Center
  Purpose
Maintenance venom immunotherapy administered at 6-month intervals to bee-venom allergic patients failed to provide protection from systemic reactions after sting challenges. These patients should continue their immunotherapy at 1-3 month intervals.

Condition Intervention Phase
Venom Allergy Drug: venom immunotherapy Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • whether the administration of bee venom (BV)
  • maintenance dose (MD) at 6-month interval is safe and
  • efficacious.

Estimated Enrollment: 60
Study Start Date: June 2004
Estimated Study Completion Date: May 2006
Detailed Description:

Background: The intervals at which maintenance venom immunotherapy (MVIT) is administered have been progressively extended over the years.

Objective: To examine whether the administration of bee venom (BV) maintenance dose (MD) at 6-month interval is safe and efficacious.

Methods: The usual 3-month interval at which venom allergic patients were receiving their MVIT was gradually extended to 6 months. Systemic reactions (SRs) to immunotherapy injections or to field stings were regularly recorded. BV allergic patients were deliberately sting-challenged after reaching the 6-month interval.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Venom allergy

Exclusion Criteria:

  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): NCT00684476


Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Arnon Goldberg, M.D The Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel, affiliated with The Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
  More Information

ClinicalTrials.gov Identifier: NCT00684476     History of Changes
Other Study ID Numbers: 130504
First Submitted: May 21, 2008
First Posted: May 26, 2008
Last Update Posted: May 26, 2008
Last Verified: March 2004