Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™
Summary
There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU and 18200 SU are being developed to compare with the current dose. The study is designed to explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA (without MPL) and placebo.
Timeline
- Start
- 2015-11-07
- Primary completion
- 2016-05-05
- Completion
- 2017-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Grass MATA | Other / unclassified | 0.5 ml | Subcutaneous |
| Comparator | Grass MATA | Other / unclassified | 5100 unknown | Subcutaneous |
| Subject | Grass MATA MPL | Vaccine | 0.5 ml | Subcutaneous |
| Subject | Grass MATA MPL | Vaccine | 1 ml | Subcutaneous |
| Subject | Grass MATA MPL | Vaccine | 5100 unknown | Subcutaneous |
| Subject | Grass MATA MPL | Vaccine | 10200 unknown | Subcutaneous |
| Subject | Grass MATA MPL | Vaccine | 18200 unknown | Subcutaneous |