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| ID | Type | Description | Link |
|---|---|---|---|
| P2DP05007 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ragweed MATAMPL | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| to assess whether the efficacy of RagweedMATAMPL is maintained approximately one year later during the first EEC period of 2006 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Patients must have completed both EEC periods of study P2DP5001; have had received either placebo or the top dose if they had been treated with Ragweed MATA MPL; and have had no major changes in medical history or health status since completing the study.
Patients must be willing and able to give written informed consent and provide this consent prior to initiation of any study procedures, including initiation of washout of any concomitant medications.
Patients must be willing and able to attend all study visits.
Patients must observe the drug washout times listed in Table 3.2.3 prior to Screening (Visit 1). The use of other concomitant medications will be permitted if they are not expected to interfere with the ability of the patient to participate in the study and provided that they have been on a stable regimen (i.e. the same dose and schedule of administration) for eight weeks prior to screening).
Women of childbearing potential must be using one of the following acceptable birth control methods:
Patients must be able to follow instructions
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepen Patel, MD | Allied Research International Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allied Research International Inc. | Mississauga | Ontario | L4W 1N2 | Canada |
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| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| 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 |