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Development of a self-assembling protein nanoparticle vaccine targeting Plasmodium falciparum Circumsporozoite Protein delivered in three Army Liposome Formulation adjuvants.

Development of a self-assembling protein nanoparticle vaccine targeting Plasmodium falciparum Circumsporozoite Protein delivered in three Army Liposome Formulation adjuvants.
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Seth L, Bingham Ferlez KM, Kaba SA, Musser DM, Emadi S, Matyas GR, Beck Z, Alving CR, Burkhard P, Lanar DE,


Seth L, Bingham Ferlez KM, Kaba SA, Musser DM, Emadi S, Matyas GR, Beck Z, Alving CR, Burkhard P, Lanar DE, (click to view)

Seth L, Bingham Ferlez KM, Kaba SA, Musser DM, Emadi S, Matyas GR, Beck Z, Alving CR, Burkhard P, Lanar DE,

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Vaccine 2017 03 0635(41) 5448-5454 pii 10.1016/j.vaccine.2017.02.040

Abstract

We have developed FMP014, a vaccine candidate against Plasmodium falciparum malaria, which is comprised of 60 identical monomer protein chains that form an icosahedral shaped self-assembling protein nanoparticle (SAPN). Each monomer contains selected P. falciparum Circumsporozoite Protein (PfCSP) CD4+ and CD8+ epitopes, universal TH epitopes, portions of the α-TSR domain, and 6 repeats of the NANP motifs of the PfCSP. Here we describe the conditions that are required for successful scale-up and cGMP manufacturing of FMP014 with a yield of ≈1.5g of drug substance per 100g of wet bacterial paste. When adjuvanted with an Army Liposomal Formulation (ALF) based adjuvant, the nanoparticle vaccine is highly immunogenic and prevents infection of mice by an otherwise lethal dose of transgenic P. berghei sporozoites expressing the full-length PfCSP.

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