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Sponsored by: |
Allergy Therapeutics |
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Information provided by: | Allergy Therapeutics |
ClinicalTrials.gov Identifier: | NCT00116285 |
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.
Condition | Intervention | Phase |
---|---|---|
Type I Hypersensitivity |
Biological: Ragweed MATA MPL |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
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 |
Estimated Enrollment: | 12 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Allied Research International Inc. | |
Mississauga, Ontario, Canada, L4W 1N2 |
Principal Investigator: | Deepen Patel, MD | Allied Research International Inc. |
Study ID Numbers: | RagweedMATAMPL101, P1DP05003 |
Study First Received: | June 28, 2005 |
Last Updated: | November 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00116285 |
Health Authority: | Canada: Health Canada |
allergy skin prick test allergoid allergenicity specific immunotherapy |
Monophosphoryl lipid A Hypersensitivity Hypersensitivity, Immediate |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |