Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing
Tracking Information | |||||
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First Received Date ICMJE | April 7, 2005 | ||||
Last Updated Date | June 16, 2010 | ||||
Start Date ICMJE | April 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
to assess the allergenicity of the modified tree (birch, alder, hazel) pollen allergoid using skin prick testing | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00107705 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
evaluation for potential late phase reactions; adverse events; clinical labs; vital signs | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing | ||||
Official Title ICMJE | A Single-blind Phase I Study to Assess the Residual Allergenicity of Tree (Birch, Hazel and Alder) Pollen Allergoid Using Skin Prick Testing | ||||
Brief Summary | The purpose of this study is to evaluate the residual allergenicity of Tree MATA (modified pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of the wheal response after skin prick testing with aqueous native and modified allergen, modified tyrosine adsorbed allergen and Tree MATA MPL (modified tyrosine adsorbed + MPL [Monophosphoryl Lipid A]). |
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Detailed Description | Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting tree pollens. MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is included in the product formulation as an adjuvant to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to a TH1-like profile. The tree pollen extract is modified with glutaraldehyde to produce the active ingredient, an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus reducing the risk of side effects. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivities is not seen. The purpose of this study is to assess residual allergenicity of the modified tree pollen in Tree MATA MPL using skin prick testing. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
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Condition ICMJE | Type I Hypersensitivity | ||||
Intervention ICMJE | Biological: Tree MATA MPL | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 12 | ||||
Completion Date | May 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 50 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00107705 | ||||
Other Study ID Numbers ICMJE | TreeMATAMPL101, P1DP05001 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Allergy Therapeutics | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Allergy Therapeutics | ||||
Verification Date | June 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |