the extent and effect of malaria in past military deployments are given, and the case for a vaccine is presented. The final section reviews the cost and time needed to have a high likelihood of producing an effective vaccine. Chapter 3 presents basic information on malaria and the rationale for vaccine development. The scientific background on vaccine development is necessary to place the current MIDRP Malaria Vaccine Program research in context and assess its scientific validity. The chapter also describes the scientific barriers to malaria vaccine development that have been identified. The status of current vaccine candidates and description of the MIDRP Malaria Vaccine Program’s contributions to the global vaccine effort are given. Chapter 4 describes the scientific aspects of the MIDRP Malaria Vaccine Program. In particular, the committee’s opinions on the desirable characteristics for a first-generation and later-generation vaccines are spelled out, together with advice on requirements for pivotal licensure track trials to demonstrate the recommended level of efficacy. An overview of current work on vaccines is then presented together with the committee’s overall assessment and recommendations concerning the scientific aspects of the program. Chapter 5 is concerned with the organization and management of the program. The committee’s recommendations for reorganizing and streamlining are presented here. Reference is made to previous reports on the DoD vaccine acquisition process. This chapter also discusses the adequacy of human resource and financial commitments to the program.
Appendix A is a tabulation of previous clinical P. falciparum vaccine trials. Appendix B gives the existing DoD requirements for a malaria vaccine. Appendix C provides plans for possible field trials testing malaria vaccines in nonimmune adult volunteer subjects deployed to (military personnel) or recruited to spend time in (civilians) endemic areas. Appendix D is a listing of patents granted to the program. Appendix E is a draft charter for a scientific advisory board. Appendix F gives the recommendations of a previous IOM report on DoD vaccine related issues. Appendix G gives the recommendations of a previous committee of independent experts who advised the DoD on vaccine acquisition and production. Appendix H gives the agenda of the open meeting held in January 2006, and Appendix I contains biosketches of the IOM committee and staff members.