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Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing

Primary Purpose

Type I Hypersensitivity

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Tree 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, skin prick test, allergoid, allergenicity, specific immunotherapy

Eligibility Criteria

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

Inclusion Criteria: The subject must sign the study consent form prior to any screening procedures being performed. If the volunteer is female of childbearing potential, she must demonstrate a negative urine pregnancy test and agree to remain abstinent or use an effective method of birth control or use a hormonal contraceptive The subject must demonstrate a positive skin prick test to Birch, Hazel and Alder pollen allergen extract The subject must demonstrate a positive skin prick test to positive histamine control The subject must demonstrate a negative skin prick test to negative control The subject must demonstrate a specific IgE for Birch, Hazel and Alder as documented by a RAST (radioallergosorbent test), or equivalent test The subject must have clinically acceptable results from the screening procedure. 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 skin prick tests; both forearms must be available for testing Subject has asthma or other lower respiratory tract condition 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, epithelia (cat, dog, and horse), grass mix Clinically relevant symptoms due to an IgE - mediated allergy at screening and before inclusion to the treatment period. Secondary alteration at the affected organ. History of auto-immune diseases or rheumatoid diseases Subject has a medical condition that prohibits the use of 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 Subjects determined by the Investigator to have any medical condition that could jeopardize their health or prejudice the results 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 drugs with antihistaminic activity Subject has a positive drugs of abuse screen at Visit 1 Subject participated in a clinical trial with an investigational drug within the last 30 days Subject cannot communicate reliably with the Investigator or is deemed uncooperative or noncompliant Females who are pregnant, breastfeeding, or refuse to use a reliable method of birth control Subject received treatment with a preparation containing MPL during the past 12 months Use of prohibited medications or inadequate washout periods prior to screening

Sites / Locations

  • Allied Research International Inc.

Outcomes

Primary Outcome Measures

to assess the allergenicity of the modified tree (birch, alder, hazel) pollen allergoid using skin prick testing

Secondary Outcome Measures

evaluation for potential late phase reactions; adverse events; clinical labs; vital signs

Full Information

First Posted
April 7, 2005
Last Updated
June 16, 2010
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00107705
Brief Title
Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing
Official Title
A Single-blind Phase I Study to Assess the Residual Allergenicity of Tree (Birch, Hazel and Alder) Pollen Allergoid Using Skin Prick Testing
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Allergy Therapeutics

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the residual allergenicity of Tree MATA (modified pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of the wheal response after skin prick testing with aqueous native and modified allergen, modified tyrosine adsorbed allergen and Tree MATA MPL (modified tyrosine adsorbed + MPL [Monophosphoryl Lipid A]).
Detailed Description
Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting tree pollens. 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 profile. 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. The purpose of this study is to assess residual allergenicity of the modified tree pollen in Tree MATA MPL using skin prick testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Hypersensitivity
Keywords
allergy, skin prick test, allergoid, allergenicity, specific immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Tree MATA MPL
Primary Outcome Measure Information:
Title
to assess the allergenicity of the modified tree (birch, alder, hazel) pollen allergoid using skin prick testing
Secondary Outcome Measure Information:
Title
evaluation for potential late phase reactions; adverse events; clinical labs; 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: The subject must sign the study consent form prior to any screening procedures being performed. If the volunteer is female of childbearing potential, she must demonstrate a negative urine pregnancy test and agree to remain abstinent or use an effective method of birth control or use a hormonal contraceptive The subject must demonstrate a positive skin prick test to Birch, Hazel and Alder pollen allergen extract The subject must demonstrate a positive skin prick test to positive histamine control The subject must demonstrate a negative skin prick test to negative control The subject must demonstrate a specific IgE for Birch, Hazel and Alder as documented by a RAST (radioallergosorbent test), or equivalent test The subject must have clinically acceptable results from the screening procedure. 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 skin prick tests; both forearms must be available for testing Subject has asthma or other lower respiratory tract condition 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, epithelia (cat, dog, and horse), grass mix Clinically relevant symptoms due to an IgE - mediated allergy at screening and before inclusion to the treatment period. Secondary alteration at the affected organ. History of auto-immune diseases or rheumatoid diseases Subject has a medical condition that prohibits the use of 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 Subjects determined by the Investigator to have any medical condition that could jeopardize their health or prejudice the results 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 drugs with antihistaminic activity Subject has a positive drugs of abuse screen at Visit 1 Subject participated in a clinical trial with an investigational drug within the last 30 days Subject cannot communicate reliably with the Investigator or is deemed uncooperative or noncompliant Females who are pregnant, breastfeeding, or refuse to use a reliable method of birth control Subject received treatment with a preparation containing MPL during the past 12 months 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
Allied Research International Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada

12. IPD Sharing Statement

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Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing

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