Assessment of Residual Allergenicity of Grass/Rye Pollen Allergoid Using Skin Prick Testing
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|ClinicalTrials.gov Identifier: NCT00104390|
Recruitment Status : Completed
First Posted : March 1, 2005
Last Update Posted : June 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type I Hypersensitivity||Biological: Grass MATA MPL||Phase 1|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Single-blind Phase 1 Study to Assess the Residual Allergenicity of Grass/Rye Pollen Allergoid Using Skin Prick Testing|
|Study Start Date :||March 2005|
|Estimated Study Completion Date :||April 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104390
|United States, Oregon|
|Allergy Associates Research Center|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Michael J. Noonan, MD||Allergy Associates Research Center|