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

Completed · Phase 1

Conditions studied: Type I Hypersensitivity

In brief

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).

Key facts

Study ID

NCT00104390

Run by

Allergy Therapeutics

People needed

14

Starts

2005-03-01

Expected to finish

2005-04-01

Last updated by the study team

2010-06-10

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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
• History of hypersensitivity to the excipients of the study medication
• History of immunotherapy with grass allergen extracts
• Current therapy with ß-blockers
• Currently receiving anti-allergy medication or other drugs with an 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 3 months
• Subject cannot communicate reliably with the Investigator or is not likely to cooperate with the requirements of the study
• Subject is pregnant or lactating
• Subject received treatment with a preparation containing MPL during the past 12 months
• Use of prohibited medications or inadequate washout periods prior to screening

Where it is running

• Allergy Associates Research Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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