Assessment of Residual Allergenicity of Ragweed Pollen Allergoid With Monophosphoryl Lipid A (MPL) Using Skin Prick Testing

NCT00116285 | Completed Phase 1

• 2 other identifiers: RagweedMATAMPL101P1DP05003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 prick testing. This is done by a comparison of the wheal response after skin prick testing with different concentrations of aqueous native allergen, modified allergen, modified tyrosine adsorbed allergen, and Ragweed MATA MPL.

Conditions

Type I Hypersensitivity

Keywords

allergy; skin prick test; allergoid; allergenicity; specific immunotherapy

Outcome Measures

Primary Outcomes (1)

• To assess the allergenicity of the modified ragweed pollen in Ragweed MATA MPL compared to unmodified native allergen using skin prick testing

Secondary Outcomes (1)

• To assess the safety and tolerability of the skin prick test products

Interventions

Ragweed MATA MPL BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (1)

Allied Research International Inc.

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Interventions

ragweed MATA MPL

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Deepen Patel, MD

  Allied Research International Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2005
• First Posted: June 29, 2005
• Study Start: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: June 17, 2010

Record last verified: 2009-09

Locations

CA (1)