Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing
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]).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
|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|
- 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
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||May 2005|
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.
|Allied Research International Inc.|
|Mississauga, Ontario, Canada, L4W 1N2|
|Study Chair:||Karl Jürgen Fischer von Weikersthal-Drachenberg, MD||Allergy Therapeutics|