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

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 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