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

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ClinicalTrials.gov Identifier: NCT00684476
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : May 26, 2008
Sponsor:
Information provided by:
Meir Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Venom Allergy Drug: venom immunotherapy Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2004
Estimated Study Completion Date : May 2006



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


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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:


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

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