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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program (2006)

Chapter: Appendix B Current Requirements for a Malaria Vaccine

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Suggested Citation:"Appendix B Current Requirements for a Malaria Vaccine." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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Appendix B
Current Requirements for a Malaria Vaccine

The current requirements for a Plasmodium falciparum vaccine are formulated in a U.S. Army Operational Requirements Document (ORD) dated March 13, 1997, which has now expired and will be replaced by a Capability Development Document (CDD) that is currently (January 2006) in draft. Although these documents have been prepared under the auspices of the U.S. Army, the requirements are no different for the Navy and Marines. The table below shows the requirements as they stand in the expired ORD and the draft CDD.

TABLE B-1 Current Operational Requirements for a P. falciparum Malaria Vaccine

Attribute

Development Threshold

Development Objective

Efficacy

80% protection

90% protection

Time to protection

Within 14 days

Within 7 days

Duration of protection

At least 1 year

At least 2 years

Shelf life

At least 2 years

At least 3 years

Dosing schedule

Protection will be attained after two doses

Protection will be attained after one dose

Suggested Citation:"Appendix B Current Requirements for a Malaria Vaccine." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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Page 95
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Malaria is an infectious disease common to several parts of the world, including Africa, northern South America, and Asia. During their service in the military, U.S. active members may be sent to any part of the world, including parts of the world where Malaria is an issue. In Liberia in 2003, for example, there was a 28 percent attack rate in Marines who spent a short time ashore, and half of the 80 Marines affected needed to be evacuated to Germany. This was not only costly to the U.S. military but dangerous as well. To fight against this disease, there exists a Malaria Vaccine program in the U.S. military. However, there exists a variety of potential vaccine targets for the most severe and important form of malaria; malaria from the species Plasmodium falciparum. Issues also arise with the fact that there are three possible stages to create vaccines against—preerythrocytic, blood, or transmission.

The Department of Defense (DoD), through the commanding general of the U.S. Army Medical Research and Materiel Command (USAMRMC), requested that the Institute of Medicine (IOM) conduct a programmatic review of the military Plasmodium falciparum malaria vaccine research and development program. There was to be a focus on vaccine against the preerythrocytic and blood stages. The IOM formed a committee of 11 experts with collective expertise in malaria vaccine research, parasite immunology, malarial biology, clinical trials and regulatory affairs, industrial and public-sector vaccine development, biologic products research and development (vaccinology), military research and development programs, tropical medicine, and public health.

The committee focused different tasks including determining whether the DoD malaria vaccine research and development program is scientifically sound and able to achieve the vaccine program objectives within specified timelines, recommending how to overcome significant, identified barriers, and identifying major strategic goals and timelines based on the material received and presentations made by the DoD's program representatives. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program presents the committee's findings, current malaria vaccines, and recommendations for the development of the U.S. Military vaccine research.

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