Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104390
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2005-02-28
Brief Title:
Assessment of Residual Allergenicity of GrassRye Pollen Allergoid Using Skin Prick Testing
Sponsor:
Allergy Therapeutics
Organization:
Allergy Therapeutics
Study Overview
Official Title:
A Single-blind Phase 1 Study to Assess the Residual Allergenicity of GrassRye Pollen Allergoid Using Skin Prick Testing
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the residual allergenicity of Grass 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 Grass MATA MPL modified tyrosine adsorbed MPL
Detailed Description:
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 grassrye 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
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 grassrye 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None