Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116285
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2005-06-28
Brief Title:
Assessment of Residual Allergenicity of Ragweed Pollen Allergoid With Monophosphoryl Lipid A MPL 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 Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL Using Skin Prick Testing
Status:
COMPLETED
Status Verified Date:
2009-09
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 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
Detailed Description:
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
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
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 |
|---|---|---|---|
| P1DP05003 | None | None | None |