Malaria Radical Cure Drug Efficacy Clinical Study

Background
The Walter Reed Army Institute of Research (WRAIR) and the Armed Forces Research Institute of Medical Sciences (AFRIMS) are seeking to conduct clinical studies focused on the safety and efficacy of radical cure therapies for relapsing malaria caused by Plasmodium vivax.

This initiative aims to evaluate the anti-malarial drug tafenoquine through two distinct clinical studies, one in Thailand and another in the United States.

Work Details
The Contractor will be responsible for several key tasks:
1. Conduct pre-study preparation and activities, including obtaining Institutional Review Board approval (Phase One).
2. Execute clinical studies, which involve recruitment, enrollment, drug administration, safety monitoring, urine and blood sample collection, and comprehensive study reporting (Phase Two).
3. Analyze data from both studies with a focus on malaria pharmacokinetics and pharmacogenomics, assisting in sample testing, clinical data analysis, results interpretation, and manuscript preparation (Phase Three).

Additionally, the Contractor will provide subject matter expertise on malaria research and laboratory support to facilitate data analysis and scientific publication regarding tafenoquine's efficacy.

Place of Performance
The Contractor's services will be performed at their facilities within the Continental United States (CONUS), while providing support for a Government location outside of the Continental United States (OCONUS).