Venom AllergyPhase 4NCT00684476
Maintenance Bee-Venom Immunotherapy Administered at 6-Month Intervals Does Not Protect Against re-Stings
A Phase 4 study testing venom immunotherapy in people with Venom Allergy, run by Meir Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Venom Allergy
- What is being tested?
- venom immunotherapy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to May 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Venom allergy
Who cannot join
- none
About this study
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.
Read the 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.
- Conditions
- Venom Allergy
- Being tested
- venom immunotherapy
- Medical subject headings
- Venom Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venom immunotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
whether the administration of bee venom (BV)
maintenance dose (MD) at 6-month interval is safe and
efficacious.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startJun 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venom AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Arnon Goldberg, M.D, Principal investigator, The Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel, affiliated with The Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684476
- Sponsor's protocol ID
- 130504
- Status last verified
- Mar 2004
- First submitted
- 21 May 2008
- Last updated
- 26 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Bee-Venom Immunotherapy Administered at 6-Month Intervals Does Not Protect Against re-Stings
- ClinicalTrials.gov ID
- NCT00684476
- Acronym / sponsor ID
- 130504
- Conditions
- Venom Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- May 2006
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Venom allergy
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venom immunotherapy | Drug | – |
Primary outcome
whether the administration of bee venom (BV)
maintenance dose (MD) at 6-month interval is safe and
efficacious.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2008.
Related trials for Venom Allergy
Recruiting
Is the BAT Inhibition Able to Replace Sting Challenges? (BATIRS)
Vespid Venom Allergy
RecruitingObservational study
Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure
Bee Venom Allergy
RecruitingPhase 4
Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation
Allergy, Immunotherapy
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruiting
Virtual-reality Induced Immune Modulation in Allergic Patients
Hymenoptera Venom Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Goldberg, M.D principal investigator
The Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel, affiliated with The Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing venom immunotherapy in people with Venom Allergy, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whether the administration of bee venom (BV). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2008.