Document text
Principal Investigator: Corey Casper
Organization: FRED HUTCHINSON CANCER CENTER
Fiscal Year: 2023
Award: $375,190
Funding agency: National Institute of Allergy and Infectious Diseases
Abstract
Scientific Core One has the responsibility of creating, validating, and providing R&D-grade HIV-Env
immunogen-expressing self-amplifying RNAs (saRNAs) complexed with the nanostructured lipid carrier (NLC)
delivery vehicle to project leads at Fred Hutchinson Cancer Research Center for in vivo testing as described in
Scientific Project One. AAHI’s saRNA/NLC vaccine platform has previously demonstrated robust
immunogenicity against many antigen targets, including HIV, and unparalleled stability. This technology will
now be adapted to deliver the HIV immunogens of our partners at the Fred Hutchinson Cancer Research
Center. Scientific Core One activities include design and cloning of the saRNA template DNA plasmids, saRNA
production using well-characterized and validated in vitro transcription and purification processes, and
manufacturing of the NLC delivery formulation. Upon successful saRNA and NLC manufacture, Scientific Core
One will complex of saRNA/NLC vaccine and test these vaccines in vitro to verify successful saRNA replication
and antigen production. Scientific Core One will also provide transfected cell materials to Scientific Core Two
for immunogen antigenicity testing. Finally, the stability of these R&D-grade saRNA, NLC, and complexed
saRNA/NLC materials will be verified using standard stability testing techniques to gather necessary data to
enable GMP manufacturing by Scientific Project Two, successful filing of an IND and completion of a Phase I
clinical trial.
Terms: <AIDS Virus><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Antigen Targeting><Antigens><Binding><Biological><C4 b><C4b><Cell Body><Cells><Clinical><Cloning><Complement 4b><Complement C4b><Complex><DNA><Data><Deoxyribonucleic Acid><Development and Research><Early-Stage Clinical Trials><Evaluation><Flow Cytofluorometries><Flow Cytofluorometry><Flow Cytometry><Flow Microfluorimetry><Flow Microfluorometry><Formulation><Fred Hutchinson Cancer Research Center><Future><Gene Transcription><Genetic Transcription><HIV><Harvest><Human Immunodeficiency Viruses><Immunoblotting><In Vitro><LAV-HTLV-III><Liquid substance><Lymphadenopathy-Associated Virus><Membrane><Molecular Interaction><Molecular Sieve Chromatography><Nanostructures><Non-Polyadenylated RNA><Phase 1 Clinical Trials><Phase I Clinical Trials><Process><Production><Protocol><Protocols documentation><R & D><R&D><RNA><RNA Expression><RNA Gene Products><RNA Nucleases><RNA amplification><RNA delivery><RNA replication><RNA vaccine><RNA-based vaccine><RNase><Research><Ribonuclease Family Protein><Ribonucleases><Ribonucleic Acid><Size Exclusion Chromatography><Techniques><Technology><Testing><Transcription><Transfection><VEE virus><VEEV><Vaccine Production><Vaccines><Venezuelan Equine Encephalitic Virus><Venezuelan Equine Encephalitis Virus><Venezuelan Equine Encephalomyelitis Virus><Virus-HIV><Western Blotting><Western Immunoblotting><biologic><biophysical characteristics><biophysical characterization><biophysical measurement><biophysical parameters><biophysical properties><delivery vector><delivery vehicle><design><designing><evaluate vaccines><flow cytophotometry><fluid><immunogen><immunogenicity><in vivo evaluation><in vivo testing><liquid><mRNA vaccine><mRNA-based vaccine><manufacture><membrane structure><nano particle><nano particle delivery><nano-sized particle><nano-sized structures><nano-structures><nanoparticle><nanoparticle delivered><nanoparticle delivery><nanosized particle><particle><phase I protocol><plasmid DNA><produce vaccines><product development><protein blotting><research and development><stability testing><structured lipid><vaccine evaluation><vaccine platform><vaccine screening><vaccine testing>