Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed pollen (hay fever). This novel formulation is designed to provide a vaccine that will be efficacious with only four escalating dose injections administered before the start of the pollen season. In this Follow-up Study the Efficacy will be assessed by exposing allergic subjects to Ragweed pollen in an environmental exposure chamber EEC. Patient symptomatic response to pollen and patient quality of life in the EEC will be determined. Patients who previously completed two EEC portions of study Ragweed MATAMPL 204 and who had been treated with either Ragweed MATA MPL or Placebo before the 2005 ragweed season will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Allied Research International Inc.
Mississauga, Ontario, Canada
to assess whether the efficacy of RagweedMATAMPL is maintained approximately one year later during the first EEC period of 2006
Determine whether the lack of efficacy observed for Ragweed MATA MPL in 2005 will manifest itself approximately one year later
Determine whether the immunoglobulin levels measured after treatment with Ragweed MATA MPL in 2005 have changed approximately one year later.
Determine whether the responses to the RQLQ-EEC measured after treatment with Ragweed MATA MPL in 2005 have changed approximately one year later.
Determine whether a second treatment in 2006 will modify the efficacy observed in 2005 and maintained approximately one year later in patients who had been treated with Ragweed MATA MPL.
Determine whether a second treatment in 2006 will modify the efficacy observed in 2005 and partially or completely lost approximately one year later in patients who had been treated with Ragweed MATA MPL
Determine whether a second treatment in 2006 will confer or improve the efficacy in patients who moderately responded or did not respond to Ragweed MATA MPL in 2005
Determine whether a second treatment in 2006 will modify the extent of the immunoglobulin response observed in 2005 in patients who had been treated with Ragweed MATA MPL
Determine whether a second treatment in 2006 will modify the responses to the RQLQ-EEC recorded before and after treatment in 2005
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