During the past two decades there have been two highly productive malaria vaccine research programs located within the Walter Reed Army Institute of Research (WRAIR) and the Naval Medical Research Center (NMRC). Whereas there has been considerable collaboration and cooperation between the highly committed and productive staffs of both programs, there has also been divergence of strategies and some duplication of facilities.
Recognizing the great complexity and expense of the mission to develop a malaria vaccine for the U.S. military in an era of scarce resources, the Department of Defense (DoD) asked the Institute of Medicine (IOM) to conduct a programmatic review of the military Plasmodium falciparum malaria vaccine research and development program. This review recommends ways to overcome barriers to vaccine development and to streamline the department's research efforts.
Malaria remains a severe and ongoing threat to many military deployments. The DoD Malaria Vaccine Program represents a large proportion of the global malaria vaccine effort, and has unique capabilities not readily available elsewhere, such as the well-defined sporozoite challenge model and a pilot GMP (good manufacturing practices) production facility.
The program is pursuing three distinct approaches, all of which the committee felt should continue, but there is a need to aggressively pursue fewer candidates within these main approaches and to focus on human immune responses and correlates of protection. Clinical trials in non-immune adults visiting malaria endemic areas are suggested as a possible additional approach for moving candidates forward.
The committee urges the program to adopt a generational approach to vaccine development, since even a partially protective first generation vaccine will be a useful adjunct to chemoprophylaxis while research continues to develop a vaccine sufficiently effective to be used without chemoprophylaxis.
The committee recommends that the WRAIR and NMRC malaria vaccine programs be fully integrated into a unified organizational and legal entity the Joint Task Force for Malaria Vaccine with a single scientific director. The task force should be supported by an external scientific advisory board to provide ongoing advice and assist in selection of vaccine candidates.
The committee emphasized the need to overhaul the management structure of the DoD malaria vaccine enterprise to utilize existing resources in a more rational manner, and the need for a significant infusion of additional core support.