Developing a liquid formulation for CVXGA1 COVID-19 intranasal vaccineIn this Phase I SBIR application, we propose to develop a liquid formulation for CVXGA1 COVID-19 intranasalvaccine. The ongoing global coronavirus disease 2019 (COVID-19) pandemic has resulted in the loss of manylives and social economic disruptions. Variants with higher transmission rates and ability to evade vaccine ornatural infection elicited host immune responses have continuously emerged leading to breakthroughinfections despite additional booster doses. The next generation of COVID-19 vaccine, that is also accessibleto the developing countries, is needed to stop SARS-COV-2 transmission. Parainfluenza virus type 5 (PIV5) isan excellent viral vector for expressing foreign antigens to fight many viral and bacterial pathogens. A singleintranasal immunization with CVXGA1 (PIV5 expressing SARS-CoV-2 S protein) induces mucosal, humoral,and cellular immune responses, providing protection against SARS-CoV-2 challenge in mice, hamsters,ferrets, cats, and Africa green monkeys. CVXGA1 also blocked contact transmission. CVXGA1 vaccine iscurrently in phase 1 clinical studies (NCT04954287). The current CVXGA1 vaccine is formulated in sucrosephosphate glutamine (SPG) buffer which is stable at -80 oC and -20 oC but not stable at 4 oC. The 4 oC stableliquid formulation is critical to the launch of this intranasal vaccine for global immunization. We propose toidentify a formulation which can provide CVXGA1 stability at 4 oC for a minimum of 4 months. We propose tofirst optimize the pH for CVXGA1 storage, then screen multiple excipients to select at least two leadformulations for further characterization, including immunogenicity studies. The Phase II SBIR proposal willfocus on long-term storage of CVXGA1 in the chosen dose device (such as prefilled sprayer) and vaccineevaluation after storage.
Public Health Relevance Statement: NARRATIVE
We propose to develop a liquid formulation for CVXGA1 COVID-19 intranasal vaccine. The ongoing world-wide
COVID-19 pandemic has exposed the vaccine supply shortage and reduced vaccine efficacy to emerging
variants. CVXGA1 is currently under phase 1 study and is stable at <-20 oC. Developing a new CVXGA1 liquid
formulation without the ultra-cold chain constraints is important for vaccine transportation, distribution, and
administration.
Project Terms: <2019-nCoV><2019 novel corona virus><2019 novel coronavirus><2019-nCoV vaccine>
