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Introduction

THE REVIEW PROCESS AND INPUTS

The Department of Defense (DoD), through the commanding general of the U.S. Army Medical Research and Materiel Command (USAMRMC), requested the Institute of Medicine (IOM) to conduct a programmatic review of the Plasmodium falciparum malaria vaccine research and development program. The USAMRMC seeks to pursue a world-class program aimed at developing effective vaccines against malaria in military personnel deployed to malaria endemic regions.

The DoD-funded research is coordinated within the USAMRMC by the Military Infectious Disease Research Program (MIDRP). These agencies strive to protect the U.S. military against naturally occurring infectious diseases via the development of Food and Drug Administration (FDA)-approved drugs, vaccines, and diagnostics and Environmental Protection Agency (EPA)-approved vector control systems. Malaria vaccine research in the DoD takes place at the Walter Reed Army Institute of Research (WRAIR), the Naval Medical Research Center (NMRC), and at overseas laboratories. The malaria vaccine research and development programs at these institutions are referred to jointly in this report as the MIDRP Malaria Vaccine Program. The MIDRP Malaria Vaccine Program coordinates its efforts to develop a vaccine meeting the military’s special needs with a wider global effort to develop a vaccine against malaria.

The IOM formed a review committee of 11 subject matter experts with collective expertise in malaria vaccine research, parasite immunology, malarial biology, clinical trials and regulatory affairs, industrial and



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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program 1 Introduction THE REVIEW PROCESS AND INPUTS The Department of Defense (DoD), through the commanding general of the U.S. Army Medical Research and Materiel Command (USAMRMC), requested the Institute of Medicine (IOM) to conduct a programmatic review of the Plasmodium falciparum malaria vaccine research and development program. The USAMRMC seeks to pursue a world-class program aimed at developing effective vaccines against malaria in military personnel deployed to malaria endemic regions. The DoD-funded research is coordinated within the USAMRMC by the Military Infectious Disease Research Program (MIDRP). These agencies strive to protect the U.S. military against naturally occurring infectious diseases via the development of Food and Drug Administration (FDA)-approved drugs, vaccines, and diagnostics and Environmental Protection Agency (EPA)-approved vector control systems. Malaria vaccine research in the DoD takes place at the Walter Reed Army Institute of Research (WRAIR), the Naval Medical Research Center (NMRC), and at overseas laboratories. The malaria vaccine research and development programs at these institutions are referred to jointly in this report as the MIDRP Malaria Vaccine Program. The MIDRP Malaria Vaccine Program coordinates its efforts to develop a vaccine meeting the military’s special needs with a wider global effort to develop a vaccine against malaria. The IOM formed a review committee of 11 subject matter experts with collective expertise in malaria vaccine research, parasite immunology, malarial biology, clinical trials and regulatory affairs, industrial and

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program public-sector vaccine development, biologic products research and development (vaccinology), military research and development programs, tropical medicine, and public health. The task statement presented to the committee was as follows: Determine whether the DoD malaria vaccine research and development program is scientifically sound and able to achieve the vaccine program objectives within specified timelines. Assessments will include research and development strategy, management, budget, research staff (size and capabilities), research equipment, communications, and identification of potential barriers impeding research progress. Given that significant barriers are identified, recommend how to overcome them. Identify the major strategic goals and timelines based on the material received and presentations made by the DoD’s program representatives, and recommend ways and means to improve the likelihood of achieving them. This may include, as appropriate, recommendations for an optimal configuration of program elements. Recommend any additional studies or actions that the DoD malaria vaccine program could undertake to enhance its program, including the timing and priority of such efforts. The IOM committee convened twice in person and twice by tele-conference during the period of the 6-month study. Their first meeting lasted 2.5 days, and the committee reviewed in detail the MIDRP malaria vaccine research and development program, its historical development, its current research efforts and budget, and its goals and objectives as presented by key MIDRP research staff. The USAMRMC also posed additional questions that it wished the IOM to address. An outside presenter (Dr. Filip Dubovsky of the Malaria Vaccine Initiative [MVI]) was also invited to give a global nonmilitary perspective. The IOM committee convened a closed session to deliberate and outline the programmatic review findings and proposed recommendations. At the second meeting, the committee reviewed a draft report and prepared its findings and recommendations. The committee report was subject to external peer review, in accordance with the usual IOM procedures, prior to final approval for release. The committee was able to build on some earlier work, including a 1996 IOM workshop report entitled Vaccines Against Malaria: Hope in a Gathering Storm that was prepared for a consortium of federal and private

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program sponsors (IOM, 1996). The following three findings reached by the participants of the 1996 workshop are especially pertinent to this review: (1) malaria is still the most prevalent vector-borne disease in the world, (2) a malaria vaccine is feasible, and (3) the high cost of vaccine development dictates a coordinated strategy and a need to focus on a limited number of options (IOM, 1996). The committee also reviewed the recent Malaria Vaccine Technology Roadmap (Roadmap, 2006), produced by a broad consensus process, with funding from the Bill and Melinda Gates Foundation and the Wellcome Trust. The Malaria Vaccine Technology Roadmap is a draft guide produced by the international community of researchers devoted to the development of an effective malaria vaccine. The roadmap identifies major barriers that need to be overcome in order to advance the development of an effective vaccine and recommends strategic priorities and approaches. The timetable of meetings for the IOM study committee was as follows: First meeting: January 23–25, 2006, at Silver Spring, Maryland Teleconference: February 15, 2006 Second meeting: February 22–23, 2006, at Irvine, California Teleconference: March 14, 2006 SCOPE AND ORGANIZATION OF THE REPORT All four species of human malaria (P. falciparum, P. vivax, P. ovale, and P. malariae) present a threat. The potentially fatal P. falciparum is the most severe and important, although P. vivax causes debilitating disease and is common in many areas outside Africa. Vaccines can be developed from any of three possible stages of malaria—the preerythrocytic, blood, or transmission stages. This report focuses on the first two of these stages. The transmission stage type of vaccine is not a current active area of research in the MIDRP Malaria Vaccine Program. Although potentially effective in reducing transmission levels and hence new infections, this strategy is less useful for immediate individual protection on arrival in an endemic area. As requested by USAMRMC, the committee restricted its deliberations to P. falciparum malaria—the current focus of the MIDRP Malaria Vaccine Program—and to vaccines against the preerythrocytic and blood stages. A list of recommendations is provided in Box S-1. The report is divided into five chapters and has nine appendixes. Chapter 1, the current chapter, is the Introduction, describing how this study came about, the charge to the committee, and the processes by which the committee went about its task. Chapter 2 describes the magnitude of the malaria problem in the world and the threat this presents to the military. Data on

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program 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.