Type I Hypersensitivity Clinical Trial
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
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 3 | |
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Phase 1 |