Type I Hypersensitivity Clinical Trial
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.
The safety and tolerability of tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (MPL) was planned to be evaluated. For this purpose, a total of 4 injections of either increasing doses of the study drug or placebo (tyrosine) was planned to be administered in 7-day intervals to healthy volunteers.
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 was planned to be a phase I, double-blind, placebo-controlled study to evaluate the safety and tolerability of RagweedMATAMPL in healthy volunteers. Fifteen (15) volunteers were planned to be randomized to receive up to 4 subcutaneous injections of either increasing doses of RagweedMATAMPL or Placebo over 7 day intervals. ;
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