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



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