GMP Production and Clinical Trial of a Self-Assembling Protein Nanoparticle and Toll-Like Receptor Liposomal MPL Adjuvanted Malaria Vaccine
Abstract
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 immune response to the protein nanoparticle FMP014. The first year of this three year project was focused on the GMP manufacture of these two key components and was reported last year. The results of second year of this project, reported here, are focused on the evaluation of the two components, both chemically and immunologically. To evaluate the components chemically we focused on identification of the bio-physical characteristics (identification by sequence analysis, size assembled nanoparticle, identification by monoclonal and stability over time) of each component; for evaluation of the immunological characteristics we focused on the immune responses (titer to NANP repeat and C-terminal epitopes, demonstration of induction of protective antibodies; and induction of cellular cytokines in mice and non-human primates) when the FMP014 and adjuvant were combined and injected into the animals. In addition we began an evaluation of the potential toxicity of the components either 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2021
- Accession Number
- AD1145000
Entities
People
- Evelina Angov
Organizations
- Henry M. Jackson Foundation for the Advancement of Military Medicine