- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00116285
Assessment of Residual Allergenicity of Ragweed Pollen Allergoid With Monophosphoryl Lipid A (MPL) Using Skin Prick Testing
A Single-Blind Phase I Study to Assess the Residual Allergenicity of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL Using Skin Prick Testing
Study Overview
Status
Conditions
Intervention / Treatment
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, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is included in the product formulation as an adjuvant to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to a TH1-like profile.
The ragweed pollen extract is modified with glutaraldehyde to produce the active ingredient, an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus reducing the risk of side effects. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivities is not seen.
The purpose of this study is to assess residual allergenicity of the modified ragweed pollen in Ragweed MATA MPL using skin prick testing.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Mississauga, Ontario, Canada, L4W 1N2
- Allied Research International Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To assess the allergenicity of the modified ragweed pollen in Ragweed MATA MPL compared to unmodified native allergen using skin prick testing
|
Secondary Outcome Measures
Outcome Measure |
---|
To assess the safety and tolerability of the skin prick test products
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RagweedMATAMPL101
- P1DP05003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type I Hypersensitivity
-
Allergy TherapeuticsCompletedType I HypersensitivityUnited States
-
Allergy TherapeuticsCompletedType I HypersensitivityGermany
-
Allergy TherapeuticsCompletedType I HypersensitivityCanada
-
Allergy TherapeuticsCompleted
-
Allergy TherapeuticsCompletedType I HypersensitivityUnited States
-
Allergy TherapeuticsCompleted
-
Allergy TherapeuticsCompletedType I HypersensitivityUnited States, Canada, United Kingdom, Austria
-
Allergy TherapeuticsCompletedType I HypersensitivityUnited States
-
Allergy TherapeuticsWithdrawnType I HypersensitivityCanada
-
Allergy TherapeuticsCompleted
Clinical Trials on Ragweed MATA MPL
-
Allergy TherapeuticsCompleted
-
Allergy TherapeuticsCompletedType I HypersensitivityUnited States
-
Allergy TherapeuticsCompleted
-
Allergy TherapeuticsCompletedType I HypersensitivityCanada
-
Allergy TherapeuticsCompletedType I HypersensitivityUnited States
-
Allergy TherapeuticsCompletedSeasonal Allergic RhinitisUnited States
-
Allergy TherapeuticsInflamax Research Incorporated; Metronomia Clinical Research GMBHCompletedAllergic RhinitisUnited States
-
Allergy TherapeuticsCompletedType I HypersensitivityCanada
-
Allergy TherapeuticsTerminated
-
Allergy TherapeuticsSynteractHCR; Metronomia Clinical Research GMBHCompletedSeasonal Allergic RhinitisUnited States