Assessment of Residual Allergenicity of Grass/Rye Pollen Allergoid Using Skin Prick Testing

NCT00104390 | Completed Phase 1

• 1 other identifier: GrassMATAMPL101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the residual allergenicity of Grass 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 Grass MATA MPL (modified tyrosine adsorbed + MPL).

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 grass/rye pollen allergoid using skin prick testing

Secondary Outcomes (4)

• evaluation for potential late phase reactions

• adverse events

• clinical labs

• vital signs

Interventions

Grass MATA MPL BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Positive skin prick test to grass and 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
• 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.

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 bronchial asthma or other lower respiratory tract condition (i.e., emphysema, bronchiectasis)
• 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 (cat, dog, and horse). Sensitivity will be determined by a skin prick test at Visit 1, a RAST (or equivalent method) at Visit 1, or a documented history of symptoms to perennial allergens. Subjects may be enrolled in the study if they test positive, 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.
• Sensitivity will be determined by a skin prick test at Visit 1, a RAST (or equivalent method) at Visit 1, or a documented history of symptoms to springtime (non-grass/rye) allergens. Subjects may be enrolled in the study if they test positive, 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

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (1)

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Michael J. Noonan, MD

  Allergy Associates Research Center

  PRINCIPAL INVESTIGATOR

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: February 28, 2005
• First Posted: March 1, 2005
• Study Start: March 1, 2005
• Study Completion: April 1, 2005
• Last Updated: June 10, 2010

Record last verified: 2010-06

Locations

US (1)