Type I Hypersensitivity Clinical Trial
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
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]).
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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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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