Assessment of Residual Allergenicity of Grass/Rye Pollen Allergoid Using Skin Prick Testing
|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 1 Study to Assess the Residual Allergenicity of Grass/Rye Pollen Allergoid Using Skin Prick Testing|
- to assess the allergenicity of the modified grass/rye pollen allergoid using skin prick testing
- evaluation for potential late phase reactions
- adverse events
- clinical labs
- vital signs
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||April 2005|
Grass MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass 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 T cell profile.
The grass 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 modification is greater than 75 %, so that only a small amount of unmodified allergen is remaining in the product. The purpose of this study is to assess residual allergenicity of the modified grass/rye pollen in Grass MATA MPL using skin prick testing.
In this skin prick test, the following test products will be compared:
- 7 concentrations of aqueous native allergen
- aqueous modified allergen
- modified tyrosine adsorbed allergen
- Grass MATA MPL (modified tyrosine adsorbed + MPL)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104390
|United States, Oregon|
|Allergy Associates Research Center|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Michael J. Noonan, MD||Allergy Associates Research Center|