Status:
COMPLETED
Assessment of Residual Allergenicity of Ragweed Pollen Allergoid With Monophosphoryl Lipid A (MPL) Using Skin Prick Testing
Lead Sponsor:
Allergy Therapeutics
Conditions:
Type I Hypersensitivity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the residual allergenicity of the modified ragweed pollen in Ragweed MATA MPL (modified pollen allergen tyrosine adsorbate + Monophosphoryl Lipid A) by skin pr...
Detailed Description
Ragweed MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to ragweed pollen. MPL (Monophosphoryl Lipid A), a purified, detoxif...
Eligibility Criteria
Inclusion
- If the volunteer is female of childbearing potential, she must demonstrate a negative urine pregnancy test and agree to remain abstinent or use an effective method of birth control
- Positive skin prick test to ragweed pollen allergen extract
- Positive skin prick test to positive histamine control
- Negative skin prick test to negative control; redness, but no wheal is acceptable
- The subject must demonstrate a specific IgE for ragweed with class \>= 2.
- The subject must have clinically acceptable results from the screening procedure including blood pressure (BP), heart rate (HR), electrocardiogram (ECG), physical examination, medical history, hematology, biochemistry, infection screen (hepatitis B antigen, hepatitis C antibody, HIV), urine pregnancy test, urinalysis, drugs of abuse screening panel and saliva alcohol testing
Exclusion
- 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 asthma or other lower respiratory tract condition
- 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 of the following common perennial or seasonal allergens: house dust mites, molds, epithelia, grass pollen mix, plantain, orache, nettle, mugwort, bermuda grass
- Clinically relevant symptoms due to an IgE-mediated allergy at screening and before inclusion to the treatment period
- Secondary alteration at the affected organ
- History of auto-immune diseases or rheumatoid diseases
- Medical condition that prohibits the use of adrenaline
- Disorder of tyrosine metabolism
- Diseases interfering with the immune response and having received medication which could influence the results of this study
- Subject has acute or chronic infection
- History of anaphylaxis
- Subjects determined by the Investigator to have any medical condition that could jeopardize their health or prejudice the results
- History of hypersensitivity to the excipients of the study medication
- History of immunotherapy with ragweed 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 and has taken investigational drug within the last 30 days
- Subject cannot communicate reliably with the Investigator or is deemed uncooperative or noncompliant
- Females who are pregnant, breastfeeding, or refuse to use a reliable method of birth control
- Subject received treatment with a preparation containing MPL during the past 12 months
- Use of prohibited medications or inadequate washout periods prior to screening
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00116285
Start Date
June 1 2005
End Date
June 1 2005
Last Update
June 17 2010
Active Locations (1)
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1
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2