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Induction of Immunogenicity With Different Doses of TreeMATA in Subjects Allergic to Tree Pollen

Primary Purpose

Type I Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TreeMATA 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 trees Positive skin prick test to birch, hazel and alder pollen allergen extract Positive skin prick test to positive histamine control Negative skin prick test to negative control Specific IgE for birch with class >= 2 Moderate/severe allergy symptoms in the past tree 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 History of bronchial asthma, COPD, or other chronic condition of the lower respiratory tract History or presence of diabetes, 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. Subjects may be enrolled in the study if they test positive, but have no current symptoms to perennial allergens Clinically relevant sensitivity to summer/autumn flowering plants and grasses: Grass pollen mix, rye, plantain, orache, nettle, mugwort, bermuda grass, and ragweed. Subjects may be enrolled in the study if they test positive, but have no current symptoms to these summer/autumn allergens. History of auto-immune diseases or rheumatoid diseases Subject not allowed to receive adrenalin Subject has disorder of tyrosine metabolism 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 History of angioedema History of hypersensitivity to the excipients of the study medication History of immunotherapy with tree allergen extracts Current therapy with ß-blockers Currently receiving anti-allergy medication or other medications with antihistaminic activity Subject has a positive screening test to drugs of abuse at Visit 1 Subject received investigational medication in a clinical research trial within the last 3 months Subject cannot communicate reliably with the Investigator or who are 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

  • Southern California Research
  • San Jose Clinical Research, Inc.
  • Rx Research
  • Iowa Clinical Research Corporation
  • The Medical Center at Teaneck
  • Clinical Research Institute of Southern Oregon, PC
  • Asthma and Allergy Research Associates
  • Bellingham Asthma, Allergy & Immunology Clinic
  • A.S.T.H.M.A., Inc.
  • Pulmonary Consultants

Outcomes

Primary Outcome Measures

Post-injection antibody response to birch

Secondary Outcome Measures

Adverse Events (AEs)
Clinical laboratory evaluations
Vital signs

Full Information

First Posted
June 10, 2005
Last Updated
June 16, 2010
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00113750
Brief Title
Induction of Immunogenicity With Different Doses of TreeMATA in Subjects Allergic to Tree Pollen
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Allergy Therapeutics

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

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)
TreeMATA MPL
Primary Outcome Measure Information:
Title
Post-injection antibody response to birch
Secondary Outcome Measure Information:
Title
Adverse Events (AEs)
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 trees Positive skin prick test to birch, hazel and alder pollen allergen extract Positive skin prick test to positive histamine control Negative skin prick test to negative control Specific IgE for birch with class >= 2 Moderate/severe allergy symptoms in the past tree 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 History of bronchial asthma, COPD, or other chronic condition of the lower respiratory tract History or presence of diabetes, 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. Subjects may be enrolled in the study if they test positive, but have no current symptoms to perennial allergens Clinically relevant sensitivity to summer/autumn flowering plants and grasses: Grass pollen mix, rye, plantain, orache, nettle, mugwort, bermuda grass, and ragweed. Subjects may be enrolled in the study if they test positive, but have no current symptoms to these summer/autumn allergens. History of auto-immune diseases or rheumatoid diseases Subject not allowed to receive adrenalin Subject has disorder of tyrosine metabolism 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 History of angioedema History of hypersensitivity to the excipients of the study medication History of immunotherapy with tree allergen extracts Current therapy with ß-blockers Currently receiving anti-allergy medication or other medications with antihistaminic activity Subject has a positive screening test to drugs of abuse at Visit 1 Subject received investigational medication in a clinical research trial within the last 3 months Subject cannot communicate reliably with the Investigator or who are 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
Karl Jürgen Fischer von Weikersthal-Drachenberg, MD
Organizational Affiliation
Allergy Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
San Jose Clinical Research, Inc.
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Rx Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
Facility Name
Iowa Clinical Research Corporation
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
The Medical Center at Teaneck
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
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
Asthma and Allergy Research Associates
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Bellingham Asthma, Allergy & Immunology Clinic
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
A.S.T.H.M.A., Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Pulmonary Consultants
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

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Induction of Immunogenicity With Different Doses of TreeMATA in Subjects Allergic to Tree Pollen

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