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Efforts Toward Short Term Objectives (up to 3 Years
Year-1
Set up a Clinical Trial Platform for CL
•Develop Standard Protocol
•Set up communication with all sites
Select trial sites and prepare for trials
•Adapt the standard protocol
•Enhance c-GCP through preparation for a specific trial
(i.e. establish ERB, DSMB,…
•Set up GCP Training Workshops
•Set up infrastructure for the trial …
Tox studies of selected combinations (if necessary)
Immunomodulator
Standardize killed parasite vaccine:
•Grow in defined medium
•Establish potency assay
•Develop lot release test
Follow Second Generation Vaccine
•Develop in collaboration
Antiparasitic
Year-2
Conduct Phase 1-2 trials of combined drugs
Conduct Phase 1-2 trials
•Short term + topical
•Short term drug + Immuno-modulator
(Imiquimod, CpG)
•Short term other combination to
selected
•Short term drug + therapeutic vaccines
Year-3
Decision Matrix for Short Term Objectives