Production of Purified Recombinant Proteins for Development of Vaccines of Military Importance

Malaria caused by Plasmodium falciparum affects 300-500 million and kills 1-3 million individuals annually. For more than 150 years during every military campaign conducted where malaria was transmitted, U.S. forces have had more casualties from malaria than from hostile fire. For these reasons malaria vaccine development is one of the highest ranked objectives for DoD biomedical R&D. Five P. falciparum proteins, PfCSP, PfSSP2, PfLSA1, PfAMA1 and PfMSP1 are considered prime targets for inclusion in a malaria vaccine. In a Phase I SBIR we demonstrated the feasibility of producing one of these proteins, PfCSP, in a highly immunogenic form. In Phase II we will produce 20-50 mg of purified, well characterized, recombinant proteins based on these antigens, demonstrate that the proteins are immunogenic in mice, and provide the proteins to the Naval Medical Research Center for use as reagents in their vaccine development program. In addition we will produce protocols and reagents that are transferable to Investigational New Drug (IND) applications and FDA directed studies. Thus, by the end of Phase II, we will have the data, material, and protocols required to take these proteins forward, not only as reagents, but also as vaccines on their own