Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen - Full Text View

Sponsored by:	Allergy Therapeutics
Information provided by:	Allergy Therapeutics
ClinicalTrials.gov Identifier:	NCT00104377

Purpose

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
Type I Hypersensitivity	Biological: Grass MATA MPL	Phase II

MedlinePlus related topics: Allergy

U.S. FDA Resources

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

Further study details as provided by Allergy Therapeutics:

Primary Outcome Measures:

To assess specific immunological changes (IgG, IgG1, IgG4, IgE) in grass and rye allergic subjects following 2 subcutaneous injections of study medication (different doses of Grass MATA or placebo) administered 3 weeks apart.

Secondary Outcome Measures:

adverse events
clinical laboratory evaluations
vital signs

Estimated Enrollment:	70
Study Start Date:	March 2005
Estimated Study Completion Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females of childbearing potential may enter the study if they have a negative urine pregnancy test and they have been practicing adequate contraception for 3 months prior to the study and continue to do so during the study
History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis without bronchial asthma due to an IgE mediated allergy to pollen from grasses and rye
Positive skin prick test to grass pollen and to rye pollen allergen extract
Positive skin prick test to positive histamine control
Negative skin prick test to negative control
Specific IgE for grass and rye as documented by a RAST or equivalent test
Moderate/severe allergy symptoms in the past spring season
Spirometry at Screening demonstrates FEV1 >= 80% predicted and FEV1/FVC >= 70%.

Exclusion Criteria:

History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of skin prick test results
Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the screening skin prick tests; both forearms must be available for testing
History of bronchial asthma, chronic obstructive pulmonary disease (COPD), or other chronic condition of the lower respiratory tract
History or presence of diabetes (insulin dependent and non-dependent), cancer or any clinically significant cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders
Any clinically significant abnormal laboratory value at Visit 1
Clinically relevant sensitivity to any common perennial allergen: house dust mites, molds, or epithelia (cat, dog, and horse). Subjects may be enrolled in the study if they test positive (skin prick test or RAST), but have no current or historical symptoms to perennial allergens.
Clinically relevant sensitivity to any common springtime flowering plant: Birch, Oak, Sycamore, Beech, Ash and Poplar. Subjects may be enrolled in the study if they test positive (skin prick test or RAST), but have no current or historical symptoms to these springtime allergens.
History of auto-immune diseases or rheumatoid diseases
Subject not allowed to receive adrenalin
Subject has disorder of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia)
Subject with diseases interfering with the immune response and have received medication, which could influence the results of this study
Subject has acute or chronic infection
History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
History of angioedema
History of hypersensitivity to the excipients of the study medication
History of immunotherapy with grass allergen extracts
Current therapy with ß-blockers
Currently receiving anti-allergy medication or other medications with an antihistaminic activity
Subject has a positive drugs of abuse screen at Visit 1
Subject participated in a clinical trial with an investigational medication within the last 3 months
Subject cannot communicate reliably with the Investigator or is not likely to cooperate with the requirements of the study
Subject is pregnant or lactating
Use of prohibited medications or inadequate washout periods prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104377

Locations

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

Sponsors and Collaborators

Allergy Therapeutics

Investigators

Principal Investigator:

Paul H. Ratner, MD

Sylvana Research Associates

More Information

No publications provided

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

Keywords provided by Allergy Therapeutics:

Allergy
Allergoid
Specific Immunotherapy

Study placed in the following topic categories:

Hypersensitivity
Hypersensitivity, Immediate

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 07, 2009