Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen

NCT00104377 | Completed Phase 2

• 1 other identifier: GrassMATAMPL201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 11

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.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Allergoid; Specific Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• adverse events

• clinical laboratory evaluations

• vital signs

Interventions

Grass MATA MPL BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (11)

College Park Family Care Center Multi-Specialty Clinical Research

Overland Park, Kansas, 66210, United States

Location

Northeast Medical Research Associates

North Dartmouth, Massachusetts, 02747, United States

Location

Midwest Clinical research, LLC

St Louis, Missouri, 63141, United States

Location

Allergy, Asthma, and Immunology Assoc. PC

Lincoln, Nebraska, 68505, United States

Location

Asthma, Sinus, and Allergy Centers, LLC

Tinton Falls, New Jersey, 07701, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Asthma and Allergy Research Associates

Upland, Pennsylvania, 19013, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Paul H. Ratner, MD

  Sylvana Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2005
• First Posted: March 1, 2005
• Study Start: March 1, 2005
• Study Completion: November 1, 2005
• Last Updated: June 17, 2010

Record last verified: 2009-09

Locations

US (11)