Induction of Immunogenicity With Different Doses of TreeMATA in Subjects Allergic to Tree Pollen - Full Text View

Sponsored by:	Allergy Therapeutics
Information provided by:	Allergy Therapeutics
ClinicalTrials.gov Identifier:	NCT00113750

Purpose

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.

Condition	Intervention	Phase
Type I Hypersensitivity	Biological: TreeMATA 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 Tree MATA in Subjects Allergic to Tree Pollen

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by Allergy Therapeutics:

Primary Outcome Measures:

Post-injection antibody response to birch

Secondary Outcome Measures:

Adverse Events (AEs)
Clinical laboratory evaluations
Vital signs

Estimated Enrollment:	70
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2005

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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113750

Locations

United States, California
Southern California Research
Mission Viejo, California, United States, 92691
San Jose Clinical Research, Inc.
San Jose, California, United States, 95128
United States, Georgia
Rx Research
Woodstock, Georgia, United States, 30188
United States, Iowa
Iowa Clinical Research Corporation
Iowa City, Iowa, United States, 52240
United States, New Jersey
The Medical Center at Teaneck
Teaneck, New Jersey, United States, 07666
United States, Oregon
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Asthma and Allergy Research Associates
Upland, Pennsylvania, United States, 19013
United States, Washington
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, United States, 98225
Pulmonary Consultants
Tacoma, Washington, United States, 98405
A.S.T.H.M.A., Inc.
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Allergy Therapeutics

Investigators

Study Chair:

Karl Jürgen Fischer von Weikersthal-Drachenberg, MD

Allergy Therapeutics

More Information

No publications provided

Study ID Numbers:	TreeMATAMPL201
Study First Received:	June 10, 2005
Last Updated:	July 3, 2006
ClinicalTrials.gov Identifier:	NCT00113750 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 August 30, 2009