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Principal Investigator: MORIYA TSUJI
Organization: COLUMBIA UNIVERSITY HEALTH SCIENCES
Fiscal Year: 2023
Award: $1,411,690
Funding agency: National Institute of Allergy and Infectious Diseases
The goal of this contract project is to develop the glycolipid-based adjuvant for human use, with initial indications for a malaria vaccine. The scope of our product development project is to develop our novel CD1d-binding natural killer T (NKT) cell-stimulatory glycolipid, called 7DW8-5, as a versatile vaccine adjuvant. Initial partner vaccines are based on a nucleic acid-based priming and whole parasite-based boosting liver-targeted malaria vaccine. We have published that that the 7DW8-5 glycolipid significantly increases the immunogenicity and efficacy of the nucleic acid prime-and-parasite trap malaria vaccines in a mouse model and have additional data showing that the adjuvant simplifies formulation and administration of this vaccine. Here, we will evaluate non-GMP-grade 7DW8-5 for formulation, solubility, release, stability, and toxicology. We will also confirm safety, immunogenicity, and efficacy of the 7DW8-5/malaria vaccine in non-human primates (NHPs). Lastly, we will develop a pre-IND regulatory package for future 7DW8-5 FDA review.
Terms: <Adjuvant><Antigens><Attenuated><Binding><Biolistics><Bite><Cell-Mediated Lympholytic Cells><Contracting Opportunities><Contractor><Contracts><Culicidae><Cytolytic T-Cell><Cytotoxic T Cell><Cytotoxic T-Lymphocytes><Data><Formulation><Future><Gene-Gun Technique><Glycolipids><Goals><Human><Liver><Malaria Vaccines><Malarial Vaccines><Mice><Mice Mammals><Modern Man><Molecular Interaction><Mosquitoes><Murine><Mus><Nucleic Acids><Parasites><Publishing><RNA replication><RNA vaccine><RNA-based vaccine><Radiation><Safety><Solubility><Sporozoites><Toxicology><Vaccine Adjuvant><Vaccine Antigen><Vaccines><attenuate><attenuates><efficacy study><gene gun><hepatic body system><hepatic organ system><immunogen><immunogenicity><killer T cell><mRNA vaccine><mRNA-based vaccine><manufacture><mouse model><murine model><non-human primate><nonhuman primate><novel><product development><vaccination study><vaccination trial><vaccine strategy><vaccine study><vaccine trial><vaccines against malaria>