A -- Malaria Vaccines: Clinical Research and Trial Sites in Endemic Areas

The Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to expand the current contract HHSN266200400016C with the Noguchi Memorial Institute for Medical Research to include additional field sites under Authority of 41 U.S.C. 253(c)(1), as set fort in FAR 6.302-1(b)(1)(i), Unique Capabilities. To help field sites prepare to conduct candidate malaria vaccine trials, the NIAID has provided support for malaria clinical research and trial site development in malaria endemic areas in sub-Saharan Africa. In addition, there are presently several field sites in Africa that have taken a multidisciplinary approach to malaria research, combining clinical, immunologic, genetic, entomologic, and other related studies. The purpose of this contract is to further enhance the capacity of existing sites and to conduct in them the iterative phase 1, 2, and 3 clinical trials required to demonstrate the safety, immunogenicity, and efficacy of candidate malaria vaccines prior to licensure. The NIAID has an urgent need to provide additional field site capacity to evaluate candidate malaria vaccines utilizing the multidisciplinary approach. These field sites should be able to provide a population census of approximately 50 to 100 thousand individuals under demographic surveillance. In addition, these field sites must be located in politically and socially stable parts of Africa, where travel by US government staff and their contractors would not be limited by security concerns. If there are responsible sources who feel that they are able to perform the requirement, they must respond by submitting their interest and a capability statement demonstrating their ability to assume the work without unnecessary delay or duplication of costs and effort. See Government-Wide numbered notes 22 and 26.