Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107705
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2005-04-07
Brief Title:
Assessment of Residual Allergenicity of Tree Birch Hazel and Alder Pollen Allergoid Using Skin Prick Testing
Sponsor:
Allergy Therapeutics
Organization:
Allergy Therapeutics
Study Overview
Official Title:
A Single-blind Phase I Study to Assess the Residual Allergenicity of Tree Birch Hazel and Alder 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:
False
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 Tree 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 Tree MATA MPL modified tyrosine adsorbed MPL Monophosphoryl Lipid A
Detailed Description:
Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting tree 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 profile
The tree 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 tree pollen in Tree MATA MPL using skin prick testing
The tree 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 tree pollen in Tree MATA MPL using skin prick testing
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P1DP05001 | None | None | None |