Assessment of Residual Allergenicity of Ragweed Pollen Allergoid With Monophosphoryl Lipid A (MPL) Using Skin Prick Testing
The purpose of this study is to evaluate the residual allergenicity of the modified ragweed pollen in Ragweed MATA MPL (modified pollen allergen tyrosine adsorbate + Monophosphoryl Lipid A) by skin prick testing. This is done by a comparison of the wheal response after skin prick testing with different concentrations of aqueous native allergen, modified allergen, modified tyrosine adsorbed allergen, and Ragweed MATA MPL.
|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 Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL Using Skin Prick Testing|
- To assess the allergenicity of the modified ragweed pollen in Ragweed MATA MPL compared to unmodified native allergen using skin prick testing
- To assess the safety and tolerability of the skin prick test products
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||June 2005|
Ragweed MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to ragweed pollen. 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 ragweed 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 ragweed pollen in Ragweed MATA MPL using skin prick testing.
|Allied Research International Inc.|
|Mississauga, Ontario, Canada, L4W 1N2|
|Principal Investigator:||Deepen Patel, MD||Allied Research International Inc.|