Hymenoptera Venom AllergyNCT00947908
Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
A study testing Hymenoptera venom in people with Hymenoptera Venom Allergy, run by University of Rostock at 1 site in Germany.
Trial summary
Dendritic cells (DC) play a key role in the pathogenesis of allergic diseases. The regulation of blood dendritic cells in patients with hymenoptera venom allergy before and during immune therapy is unknown. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Hymenoptera Venom Allergy
- What is being tested?
- Hymenoptera venom
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Jun 2010
- Phase
- Interventional
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diagnosed hymenoptera venom allergy
- No previous treatments for hymenoptera venom allergy
Who cannot join
- Treatment with immunosuppressive agents
- Any malignant disease
- Infections within 1 week prior to the initiation of the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Dendritic cells (DC) play a key role in the pathogenesis of allergic diseases. The regulation of blood dendritic cells in patients with hymenoptera venom allergy before and during immune therapy is unknown.
- Conditions
- Hymenoptera Venom Allergy
- Being tested
- Hymenoptera venom
- Keywords
- Hymenoptera venom allergy, Dendritic cells (DC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hymenoptera venomBiological
Patients are treated with hymenoptera (bee or wasp) venom using subcutaneous injections. The initiation of immune therapy consists of a 52-hour-period in which patients are treated with increasing doses of hymenoptera venom. Afterwards, patients are treated with monthly subcutaneous injections with a fixed dose of hymenoptera venom. Blood will be collected directly before and 1 hour after initiation of immune therapy and after 12 months of immune therapy (directly before the next subcutaneous injection of hymenoptera venom).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients are treated with hymenoptera (bee or wasp) venom using subcutaneous injections. The initiation of immune therapy consists of a 52-hour-period in which patients are treated with increasing doses of hymenoptera venom. Afterwards, patients are treated with monthly subcutaneous injections with a fixed dose of hymenoptera venom. Blood will be collected directly before and 1 hour after initiation of immune therapy and after 12 months of immune therapy (directly before the next subcutaneous injection of hymenoptera venom). Receives: Biological: Hymenoptera venom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of myeloid DC and plasmacytoid DC in peripheral blood
Measured: Directly before, 1 hour after, and 12 months after initiation of immune therapy
Secondary outcomes (1)
Surface molecule expression on myeloid DC and plasmacytoid DC
Measured: Directly before, 1 hour after, and 12 months after initiation of immune therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hymenoptera 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947908
- Sponsor's protocol ID
- LO-0004
- Status last verified
- Jul 2009
- First submitted
- 27 Jul 2009
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bratke K, Lommatzsch M, Julius P, Kuepper M, Kleine HD, Luttmann W, Christian Virchow J. Dendritic cell subsets in human bronchoalveolar lavage fluid after segmental allergen challenge. Thorax. 2007 Feb;62(2):168-75. doi: 10.1136/thx.2006.067793. Epub 2006 Aug 23.
PubMed 16928719Dreschler K, Bratke K, Petermann S, Bier A, Thamm P, Kuepper M, Virchow JC, Lommatzsch M. Impact of immunotherapy on blood dendritic cells in patients with Hymenoptera venom allergy. J Allergy Clin Immunol. 2011 Feb;127(2):487-494.e1-3. doi: 10.1016/j.jaci.2010.12.003.
PubMed 21281873
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
- ClinicalTrials.gov ID
- NCT00947908
- Acronym / sponsor ID
- LO-0004
- Conditions
- Hymenoptera Venom Allergy
- Keywords
- Hymenoptera venom allergy, Dendritic cells (DC)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 28 Jul 2009 (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.
Dendritic cells (DC) play a key role in the pathogenesis of allergic diseases. The regulation of blood dendritic cells in patients with hymenoptera venom allergy before and during immune therapy is unknown.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Hymenoptera venomPatients are treated with hymenoptera (bee or wasp) venom using subcutaneous injections. The initiation of immune therapy consists of a 52-hour-period in which patients are treated with increasing doses of hymenoptera venom. Afterwards, patients are treated with monthly subcutaneous injections with a fixed dose of hymenoptera venom. Blood will be collected directly before and 1 hour after initiation of immune therapy and after 12 months of immune therapy (directly before the next subcutaneous injection of hymenoptera venom). |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diagnosed hymenoptera venom allergy
- No previous treatments for hymenoptera venom allergy
Key exclusion criteria (3 listed)
- Treatment with immunosuppressive agents
- Any malignant disease
- Infections within 1 week prior to the initiation of the treatment
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 |
|---|---|---|
| Hymenoptera venomPatients are treated with hymenoptera (bee or wasp) venom using subcutaneous injections. The initiation of immune therapy consists of a 52-hour-period in which patients are treated with increasing doses of hymenoptera venom. Afterwards, patients are treated with monthly subcutaneous injections with a fixed dose of hymenoptera venom. Blood will be collected directly before and 1 hour after initiation of immune therapy and after 12 months of immune therapy (directly before the next subcutaneous injection of hymenoptera venom). | Biological | A |
Primary outcome
Number of myeloid DC and plasmacytoid DC in peripheral blood
Time frame: Directly before, 1 hour after, and 12 months after initiation of immune therapy
1 secondary outcome
Surface molecule expression on myeloid DC and plasmacytoid DC
Time frame: Directly before, 1 hour after, and 12 months after initiation of immune therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 16928719Bratke K, Lommatzsch M, Julius P, Kuepper M, Kleine HD, Luttmann W, Christian Virchow J. Dendritic cell subsets in human bronchoalveolar lavage fluid after segmental allergen challenge. Thorax. 2007 Feb;62(2):168-75. doi: 10.1136/thx.2006.067793. Epub 2006 Aug 23.
- Derived from this study: PubMed 21281873Dreschler K, Bratke K, Petermann S, Bier A, Thamm P, Kuepper M, Virchow JC, Lommatzsch M. Impact of immunotherapy on blood dendritic cells in patients with Hymenoptera venom allergy. J Allergy Clin Immunol. 2011 Feb;127(2):487-494.e1-3. doi: 10.1016/j.jaci.2010.12.003.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hymenoptera venom in people with Hymenoptera Venom Allergy, run by University of Rostock at 1 site in Germany.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
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?
Number of myeloid DC and plasmacytoid DC in peripheral blood (time frame: Directly before, 1 hour after, and 12 months after initiation of immune therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00947908, which also lists 2 linked publications.
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 13 Jan 2010.