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

Primary Purpose

Type I Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Grass MATA MPL
Sponsored by
Allergy Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type I Hypersensitivity focused on measuring Allergy, Allergoid, Specific Immunotherapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • College Park Family Care Center Multi-Specialty Clinical Research
  • Northeast Medical Research Associates
  • Midwest Clinical research, LLC
  • Allergy, Asthma, and Immunology Assoc. PC
  • Asthma, Sinus, and Allergy Centers, LLC
  • Bernstein Clinical Research Center, LLC
  • Clinical Research Institute of Southern Oregon, PC
  • Allergy Associates Research Center
  • Allergy and Clinical Immunology Associates
  • Asthma and Allergy Research Associates
  • Sylvana Research Associates

Outcomes

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

Full Information

First Posted
February 28, 2005
Last Updated
June 16, 2010
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00104377
Brief Title
Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Allergy Therapeutics

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Hypersensitivity
Keywords
Allergy, Allergoid, Specific Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Grass MATA MPL
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
adverse events
Title
clinical laboratory evaluations
Title
vital signs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul H. Ratner, MD
Organizational Affiliation
Sylvana Research Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
College Park Family Care Center Multi-Specialty Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Northeast Medical Research Associates
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Midwest Clinical research, LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Allergy, Asthma, and Immunology Assoc. PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Facility Name
Asthma, Sinus, and Allergy Centers, LLC
City
Tinton Falls
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy Associates Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Allergy and Clinical Immunology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Asthma and Allergy Research Associates
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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