drugset / Trial / NCT00133146

Assessment of the Contribution of Monophosphoryl Lipid A (MPL) to a Grass Pollen Allergy Vaccine

NCT00133146 ↗

Phase 2 Completed 41 enrolled Allergy Therapeutics
RandomizedParallel-groupTriple-blindTreatment

Summary

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) was investigated in this double-blind, randomized Phase IIa study in volunteers allergic to grass and rye pollen. Additionally, this study assessed 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.

Timeline

Start
2005-09-12
Primary completion
2005-11-23
Completion
2005-11-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Grass MATA MPL Vaccine 300 unknown Subcutaneous
Subject Grass MATA MPL Vaccine 800 unknown Subcutaneous
Subject Grass MATA MPL Vaccine 2000 unknown Subcutaneous