Status:
COMPLETED
Assessment of the Contribution of Monophosphoryl Lipid A (MPL) to a Tree Pollen Allergy Vaccine
Lead Sponsor:
Allergy Therapeutics
Conditions:
Type I Hypersensitivity
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Allergic rhinitis is a nasal inflammatory disorder initiated by an immunoglobulin-E (IgE) mediated hypersensitivity to allergens. When a patient is exposed to an allergen to which he or she is sensiti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00118625
Start Date
July 1 2005
End Date
September 1 2005
Last Update
June 17 2010
Active Locations (1)
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1
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2