Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104377
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2005-02-28
Brief Title:
Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen
Sponsor:
Allergy Therapeutics
Organization:
Allergy Therapeutics
Study Overview
Official Title:
A Multicenter Single-Blind Placebo-Controlled Phase 2 Study to Evaluate the Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen
Status:
COMPLETED
Status Verified Date:
2009-09
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:
Grass MATA modified pollen allergen tyrosine adsorbate has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to grass and rye pollen Different doses of Grass MATA will be administered and immunological changes following this treatment will be assessed
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
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
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 purpose of this study is to assess specific immunological changes IgG IgG1 IgG4 and IgE in allergic subjects following 2 subcutaneous injections of different doses of study medication Grass MATA or placebo administered 3 weeks apart The immunological changes will be used to assess the performance of the R7 IgG reactivity assay over a range of clinically efficacious doses
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
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 purpose of this study is to assess specific immunological changes IgG IgG1 IgG4 and IgE in allergic subjects following 2 subcutaneous injections of different doses of study medication Grass MATA or placebo administered 3 weeks apart The immunological changes will be used to assess the performance of the R7 IgG reactivity assay over a range of clinically efficacious doses
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