PROJECT REQUIREMENTS I Universal Influenza Vaccine Manufacture 1. cGMP production of three constructs for a pan-Group 1 vaccine regimen by transient transfection and GLP toxicity testing for three HA-FN strains 2. cGMP production of two constructs for a Group 2 vaccine regimen by transient transfection and GLP toxicity testing for two HA-FN strains 3. Develop novel cell line selection methodology to enable a platform process for rapid cGMP production (including equipment purchase of a cGMP-appropriate cell sorter, $200K) 4. cGMP production by stable cell culture and GLP toxicity testing for one HA-FN strain II H7N9 Influenza Vaccine Manufacture 1. Manufacture of cGMP H7 (and in future, H3) plasmid DNA to be used as a prime for the HA-F or inactivated H7 protein boost. 2. Additionally, the VPP will manufacture pDNA to be used as a raw material for HA-F nanoparticle development and production. Regulatory approval packages will be developed, and each clinical pDNA or nanoparticle product will be filled as required for clinical trials. III Non-severable deliverable 1. cGMP clinical material for Phase 1 Clinical Trial study PROJECT ABSTRACT On April 1, 2013, the World Health Organization (WHO) first reported 3 human infections with a new influenza A (H7N9) virus in China. Although there is no evidence to date that it has done so, this virus has the potential to cause a pandemic if it were to become easily and sustainably transmissible from person-to-person.
