Assessment of the Contribution of Monophosphoryl Lipid A (MPL) to a Grass Pollen Allergy Vaccine
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass and rye pollen (hay fever).
The tolerability and immunogenicity of GrassMATA (allergen modified with glutaraldehyde and adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a bacterial cell surface) is being investigated in this double-blind, randomized Phase IIa study in volunteers allergic to grass and rye pollen.
Additionally, this study will assess residual allergenicity of the modified grass and rye pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass and rye pollen.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind Phase IIa Study to Demonstrate the Contribution of MPL to Tyrosine Adsorbed Grass/Rye Pollen Allergoid (Grass MATA) With a Single-Blind Portion to Evaluate the Residual Allergenicity in Skin Test in Volunteers Allergic to Grass and Rye Pollen|
- immunological response to GrassMATAMPL versus GrassMATA (grass specific)
- immunological response to GrassMATAMPL versus GrassMATA (rye specific)
- allergenicity of the modified grass pollen allergoid using skin prick testing
- tolerability of native allergen, modified allergen and tyrosine adsorbents +/- MPL in the skin prick tests
- tolerability of the different dose steps compared between GrassMATAMPL and GrassMATA treatment groups
- the tolerability of the cumulative subcutaneous doses compared between GrassMATAMPL and GrassMATA treatment groups
- safety laboratories
- vital signs
- 12-lead electrocardiogram (ECG)
- number of adverse events
- number of adverse reactions
|Study Start Date:||September 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133146
|Allied Research International Inc.|
|Mississauga, Ontario, Canada, L4W 1N2|
|Study Chair:||Karl Jürgen Fischer von Weikersthal-Drachenberg, MD||Allergy Therapeutics|