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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:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00684476
First received: May 21, 2008
Last updated: May 23, 2008
Last verified: March 2004
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Venom allergy

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00684476     History of Changes
Other Study ID Numbers: 130504
Study First Received: May 21, 2008
Last Updated: May 23, 2008
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013