Type I Hypersensitivity Clinical Trial
Official title:
A Multicenter, Single-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Induction of Immunogenicity With Different Doses of Tree MATA in Subjects Allergic to Tree Pollen
Tree MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to tree (birch, alder, and hazel) pollen. Different doses of Tree MATA will be administered and immunological changes following this treatment will be assessed.
Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients
with proven type I hypersensitivity to tree (birch, alder, and hazel) pollen.
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.
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 (Tree 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.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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