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Sponsored by: |
Allergy Therapeutics |
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Information provided by: | Allergy Therapeutics |
ClinicalTrials.gov Identifier: | NCT00104377 |
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.
Condition | Intervention | Phase |
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Type I Hypersensitivity |
Biological: Grass MATA MPL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study |
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 |
Estimated Enrollment: | 70 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | November 2005 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |
College Park Family Care Center Multi-Specialty Clinical Research | |
Overland Park, Kansas, United States, 66210 | |
United States, Massachusetts | |
Northeast Medical Research Associates | |
North Dartmouth, Massachusetts, United States, 02747 | |
United States, Missouri | |
Midwest Clinical research, LLC | |
St. Louis, Missouri, United States, 63141 | |
United States, Nebraska | |
Allergy, Asthma, and Immunology Assoc. PC | |
Lincoln, Nebraska, United States, 68505 | |
United States, New Jersey | |
Asthma, Sinus, and Allergy Centers, LLC | |
Tinton Falls, New Jersey, United States, 07701 | |
United States, Ohio | |
Bernstein Clinical Research Center, LLC | |
Cincinnati, Ohio, United States, 45231 | |
United States, Oregon | |
Clinical Research Institute of Southern Oregon, PC | |
Medford, Oregon, United States, 97504 | |
Allergy Associates Research Center | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
Allergy and Clinical Immunology Associates | |
Pittsburgh, Pennsylvania, United States, 15241 | |
Asthma and Allergy Research Associates | |
Upland, Pennsylvania, United States, 19013 | |
United States, Texas | |
Sylvana Research Associates | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Paul H. Ratner, MD | Sylvana Research Associates |
Study ID Numbers: | GrassMATAMPL201 |
Study First Received: | February 28, 2005 |
Last Updated: | July 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00104377 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Allergy Allergoid Specific Immunotherapy |
Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |