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

May 23, 2008 updated by: Meir Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

60

Phase

  • Phase 4

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

6 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Venom allergy

Exclusion Criteria:

  • none

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

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

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, 2004

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 26, 2008

Last Update Submitted That Met QC Criteria

May 23, 2008

Last Verified

March 1, 2004

More Information

Terms related to this study

Other Study ID Numbers

  • 130504

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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