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

Phase 4

Completed

• Conditions: Venom Allergy

• Registration Number: NCT00684476
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2004-03
• Study Start: 2004-06
• Study Completion: 2006-05
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-23
• Last Update Submitted: 2008-05-23
• Study First Posted: 2008-05-26
• Last Update Posted: 2008-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Venom allergy

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
efficacious.
maintenance dose (MD) at 6-month interval is safe and
whether the administration of bee venom (BV)