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GMP Production and Clinical Trial of a Self-Assembling Protein Nanoparticle and Toll-Like Receptor Liposomal MPL Adjuvanted Malaria Vaccine

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Henry M. Jackson Foundation Bethesda United States

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There are two main efforts in this project First, the manufacture of a protein nanoparticle, FMP014 as the protein base for a malaria vaccine.Second, the development and manufacture of an adjuvant system Army Liposome Formulations that was designed to increase the immuneresponse to the protein nanoparticle FMP014. The first year of this three year project was focused on the GMP manufacture of these two keycomponents and was reported last year. The results of second year of this project, reported here, are focused on the evaluation of the twocomponents, both chemically and immunologically. To evaluate the components chemically we focused on identification of the bio-physicalcharacteristics identification by sequence analysis, size assembled nanoparticle, identification by monoclonal and stability over time of eachcomponent for evaluation of the immunological characteristics we focused on the immune responses titer to NANP repeat and C-terminalepitopes, demonstration of induction of protective antibodies and induction of cellular cytokines in mice and non-human primates when theFMP014 and adjuvant were combined and injected into the animals. In addition we began an evaluation of the potential toxicity of the components ether individually or combined. These efforts were accomplished by a standard multi-dose toxicology study in rabbits. This investigation is still in progress. The results of these evaluations are reported here.

Descriptive Note:

Technical Report,01 Jul 2018,30 Jun 2019



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Approved For Public Release;

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