costly and dangerous episode reinforced the fact that a vaccine would be the best method of averting the threat of malaria given the likely increasing number of deployments to high-risk areas. Therefore the DoD should markedly enhance its research and development efforts to produce malaria vaccines suitable for military needs. The large investment (at least $300 million) that is required to give a high likelihood of success in producing a vaccine in the next 10 years needs to be acknowledged and planned for.

MALARIA VACCINE RESEARCH AND DEVELOPMENT IN THE U.S. MILITARY

Malaria vaccine research and development is carried out at the Walter Reed Army Institute of Research (WRAIR), the Naval Medical Research Center (NMRC), and at DoD laboratories overseas in Kenya, Thailand, Indonesia, Peru and Egypt . Management coordination of these activities is the responsibility of the tri-service Military Infectious Diseases Research Program (MIDRP) which is under the direction of USAMRMC. The malaria vaccine research and development programs at these institutions are referred to jointly in this report as the MIDRP Malaria Vaccine Program.

Malaria Vaccine Progress to Date

The MIDRP Malaria Vaccine Program is a large proportion of the global effort and has been involved in about half of all the vaccine candidates that have been or are currently in development, including several of the candidates that have progressed to clinical efficacy trials in endemic areas. The Malaria Vaccine Program has unique capabilities not readily available elsewhere, such as the well-defined sporozoite challenge model and the pilot GMP (good manufacturing practices) production facility.

Early experiments with irradiated sporozoite vaccines were encouraging, providing a measure of protection against infection. However, the generation of both antibody and cellular protective responses with subunit vaccines has proved challenging, with many failed leads and disappointments. Gene-based (DNA) vaccines have not yet fulfilled their early promise generated by results in small animal models, although progress is being made. The most encouraging recent breakthrough was the development at WRAIR of the viruslike particle RTS,S with a particular adjuvant AS02A (in collaboration with GlaxoSmithKline [GSK]).

The USAMRMC has a mandate to develop a malaria vaccine as part of its mission to protect the U.S. military against naturally occurring infectious diseases. The military’s vaccine needs differ from those of popula-



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