Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing
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|ClinicalTrials.gov Identifier: NCT00107705|
Recruitment Status : Completed
First Posted : April 8, 2005
Last Update Posted : June 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type I Hypersensitivity||Biological: Tree MATA MPL||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Single-blind Phase I Study to Assess the Residual Allergenicity of Tree (Birch, Hazel and Alder) Pollen Allergoid Using Skin Prick Testing|
|Study Start Date :||April 2005|
|Study Completion Date :||May 2005|
- to assess the allergenicity of the modified tree (birch, alder, hazel) pollen allergoid using skin prick testing
- evaluation for potential late phase reactions; adverse events; clinical labs; vital signs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107705
|Allied Research International Inc.|
|Mississauga, Ontario, Canada, L4W 1N2|
|Study Chair:||Karl Jürgen Fischer von Weikersthal-Drachenberg, MD||Allergy Therapeutics|