Type I Hypersensitivity Clinical Trial
Official title:
A Double-Blind Phase IIa Study to Demonstrate the Contribution of MPL® to Tyrosine Adsorbed Birch + Hazel + Alder Pollen Allergoid (Tree MATA) With a Single-Blind Portion to Evaluate the Residual Allergenicity in Skin Test in Volunteers Allergic to Birch and Hazel and Alder Pollen
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities
of an allergen extract to an allergic patient, is a curative approach which directly treats
the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal
specific immunotherapy for patients with an allergy to tree pollen (hay fever).
The tolerability and immunogenicity of Tree MATA (allergen modified with glutaraldehyde and
adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from
a bacterial cell surface) is being investigated in this double-blind, randomized Phase IIa
study in volunteers allergic to birch and hazel and alder pollen.
Additionally, this study will assess residual allergenicity of the modified birch and hazel
and alder pollen in the product Tree MATA MPL using skin prick testing in volunteers
allergic to birch and hazel and alder pollen.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Positive skin prick test for birch and hazel and alder allergen - Positive skin prick test to positive histamine control - Negative skin prick test to negative control - Specific IgE for birch as documented by a radioallergosorbent or equivalent test with class = 2 - History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from birch and hazel and alder - Patients must score on the disease severity questionnaire as moderate or severe. - Males or non-pregnant, non-lactating females - Willing and able to attend required study visits - Able to follow instructions - Willing and able to give written informed consent Exclusion Criteria: - Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis - Moderate to severe asthma - Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing. - History or presence of diabetes, cancer or any clinically significant cardiac, metabolic, renal, or hematologic diseases or disorders - Recent clinically significant history of hepatic, gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders - Any clinically significant abnormal laboratory value at Visit 0 - Perennial allergens: clinically relevant sensitivity to house dust mites, molds and epithelia - Patient has clinically relevant sensitivity to the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort , Bermuda grass, or ragweed. - Secondary alteration at the affected organ - History of autoimmune diseases - Patient is taking ß-blockers for any indication - Patient who is not allowed to receive adrenalin - Patients in whom tyrosine metabolism is disturbed - Presence of a disease with a pathogenesis interfering with the immune response and patient has received medication which could influence the results of this study - Documented evidence of acute or significant chronic infection - History of anaphylaxis - Documented history of angioedema - Hypersensitivity to the excipients of the study medication - Previous or current hyposensitization therapy with comparable tree allergen extracts - Currently using anti-allergy medication and other drugs with antihistaminic activity - Patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days - Patients who cannot communicate reliably with the Investigator or who are not likely to cooperate with the requirements of the study - Patient is pregnant or planning pregnancy and/or lactating - Patient has received treatment with preparation containing monophosphoryl lipid A during the past 12 months - Concurrent use of any prohibited medication(s), as listed in the study protocol. - Any systemic disorder that could interfere with the evaluation of the study medication(s) - Clinical history of drug or alcohol abuse, at the Investigator's discretion, that would interfere with the patient's participation in the study - Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Allied Research International Inc. | Mississauga | Ontario |
Lead Sponsor | Collaborator |
---|---|
Allergy Therapeutics |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | immunological response to Tree MATA MPL versus Tree MATA (birch specific) | |||
Secondary | immunological response to Tree MATA MPL versus Tree MATA (hazel and alder specific) | |||
Secondary | allergenicity of the modified tree (birch, alder, hazel) pollen allergoid using skin prick testing | |||
Secondary | tolerability of native allergen, modified allergen and tyrosine adsorbents +/- MPL in the skin prick tests | |||
Secondary | tolerability of the different dose steps compared between Tree MATA MPL and Tree MATA treatment groups | |||
Secondary | the tolerability of the cumulative subcutaneous doses compared between Tree MATA MPL and Tree MATA treatment groups | |||
Secondary | safety laboratories | |||
Secondary | vital signs | |||
Secondary | 12-lead electrocardiogram (ECG) | |||
Secondary | number of adverse events | |||
Secondary | number of adverse reactions |
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