Type I Hypersensitivity Clinical Trial
Official title:
A Single-blind Phase 1 Study to Assess the Residual Allergenicity of Grass/Rye Pollen Allergoid Using Skin Prick Testing
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).
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)
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00133146 -
Assessment of the Contribution of Monophosphoryl Lipid A (MPL) to a Grass Pollen Allergy Vaccine
|
Phase 2 | |
| Completed |
NCT00133159 -
Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen
|
Phase 2 | |
| Terminated |
NCT00387478 -
Investigation of Efficacy and Safety of Tree MATAMPL,Tree MATA, and Placebo in Patients With Birch-Induced Seasonal Allergic Rhinitis
|
Phase 2 | |
| Completed |
NCT00414141 -
Efficacy and Safety/Tolerability of Grass MATA MPL
|
Phase 3 | |
| Completed |
NCT00258635 -
Investigation of Safety+Efficacy of Different Doses of RagweedMATAMPL;Assessment of Residual Allergenicity Using Skin Prick Test
|
Phase 2 | |
| Completed |
NCT00325338 -
Follow-up Investigation of Efficacy of Ragweed MATAMPL,and Placebo in Patients With Ragweed-induced Seasonal Allergic Rhinitis
|
Phase 2 | |
| Withdrawn |
NCT00109759 -
Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL (Monophosphoryl Lipid A)
|
Phase 1 | |
| Completed |
NCT00110786 -
Investigation of Efficacy and Safety of Ragweed MATAMPL, Pollinex-R and Placebo in Patients With Ragweed Allergy
|
Phase 2 | |
| Completed |
NCT00423787 -
Efficacy and Safety/Tolerability of Ragweed MATA MPL
|
Phase 3 | |
| Completed |
NCT00104377 -
Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen
|
Phase 2 | |
| Completed |
NCT00116285 -
Assessment of Residual Allergenicity of Ragweed Pollen Allergoid With Monophosphoryl Lipid A (MPL) Using Skin Prick Testing
|
Phase 1 | |
| Completed |
NCT00118612 -
Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Tree Pollen
|
Phase 2 | |
| Completed |
NCT00113750 -
Induction of Immunogenicity With Different Doses of TreeMATA in Subjects Allergic to Tree Pollen
|
Phase 2 | |
| Completed |
NCT00118625 -
Assessment of the Contribution of Monophosphoryl Lipid A (MPL) to a Tree Pollen Allergy Vaccine
|
Phase 2 | |
| Completed |
NCT00241410 -
Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen
|
Phase 1 | |
| Completed |
NCT00107705 -
Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing
|
Phase 1 |