Document text
Principal Investigator: Zhuo Li
Organization: CYANVAC, LLC
Fiscal Year: 2022
Award: $150,000
Funding agency: National Institute of Allergy and Infectious Diseases
Developing a liquid formulation for CVXGA1 COVID-19 intranasal vaccine
ABSTRACT
In this Phase I SBIR application, we propose to develop a liquid formulation for CVXGA1 COVID-19 intranasal
vaccine. The ongoing global coronavirus disease 2019 (COVID-19) pandemic has resulted in the loss of many
lives and social economic disruptions. Variants with higher transmission rates and ability to evade vaccine or
natural infection elicited host immune responses have continuously emerged leading to breakthrough
infections despite additional booster doses. The next generation of COVID-19 vaccine, that is also accessible
to the developing countries, is needed to stop SARS-COV-2 transmission. Parainfluenza virus type 5 (PIV5) is
an excellent viral vector for expressing foreign antigens to fight many viral and bacterial pathogens. A single
intranasal 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 is
currently in phase 1 clinical studies (NCT04954287). The current CVXGA1 vaccine is formulated in sucrose
phosphate glutamine (SPG) buffer which is stable at -80 oC and -20 oC but not stable at 4 oC. The 4 oC stable
liquid formulation is critical to the launch of this intranasal vaccine for global immunization. We propose to
identify a formulation which can provide CVXGA1 stability at 4 oC for a minimum of 4 months. We propose to
first optimize the pH for CVXGA1 storage, then screen multiple excipients to select at least two lead
formulations for further characterization, including immunogenicity studies. The Phase II SBIR proposal will
focus on long-term storage of CVXGA1 in the chosen dose device (such as prefilled sprayer) and vaccine
evaluation after storage.
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