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

NCT00107705 | Completed Phase 1

• 2 other identifiers: TreeMATAMPL101P1DP05001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 \[Monophosphoryl Lipid A\]).

Conditions

Type I Hypersensitivity

Keywords

allergy; skin prick test; allergoid; allergenicity; specific immunotherapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Tree MATA MPL BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• 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.

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 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
• 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

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (1)

Allied Research International Inc.

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Karl Jürgen Fischer von Weikersthal-Drachenberg, MD

  Allergy Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 7, 2005
• First Posted: April 8, 2005
• Study Start: April 1, 2005
• Study Completion: May 1, 2005
• Last Updated: June 17, 2010

Record last verified: 2010-06

Locations

CA (1)