Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL (Monophosphoryl Lipid A)
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|ClinicalTrials.gov Identifier: NCT00109759|
Recruitment Status : Withdrawn
First Posted : May 4, 2005
Last Update Posted : June 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type I Hypersensitivity||Biological: RagweedMATAMPL||Phase 1|
RagweedMATAMPL (tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (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.
This will be a phase I, double-blind, placebo-controlled study to evaluate the safety and tolerability of RagweedMATAMPL in healthy volunteers. Fifteen (15) volunteers will be randomized to receive up to 4 subcutaneous injections of either increasing doses of RagweedMATAMPL or Placebo over 7 day intervals.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind Phase I Study to Evaluate the Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL® in Healthy Volunteers.|
|Study Start Date :||May 2005|
|Study Completion Date :||June 2005|
- Safety and tolerability
- Tolerability of different subcutaneous doses
- Tolerability of the cumulative subcutaneous dose
- Clinical chemistry, hematology, respiratory rate, and ECG before and after each dose and at the end of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109759
|Allied Research International Inc.|
|Mississauga, Ontario, Canada, L4W 1N2|