PT  - JOURNAL ARTICLE
AU  - Lai, Chih-Yun
AU  - To, Albert
AU  - Wong, Teri Ann S.
AU  - Lieberman, Michael M.
AU  - Clements, David E.
AU  - Senda, James T.
AU  - Ball, Aquena H.
AU  - Pessaint, Laurent
AU  - Andersen, Hanne
AU  - Donini, Oreola
AU  - Lehrer, Axel T.
TI  - Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice
AID  - 10.1101/2021.03.02.433614
DP  - 2021 Jan 01
TA  - bioRxiv
PG  - 2021.03.02.433614
4099  - http://biorxiv.org/content/early/2021/03/03/2021.03.02.433614.short
4100  - http://biorxiv.org/content/early/2021/03/03/2021.03.02.433614.full
AB  - The speed at which several COVID-19 vaccines went from conception to receiving FDA and EMA approval for emergency use is an achievement unrivaled in the history of vaccine development. Mass vaccination efforts using the highly effective vaccines are currently underway to generate sufficient herd immunity and reduce transmission of the SARS-CoV-2 virus. Despite the most advanced vaccine technology, global recipient coverage, especially in resource-poor areas remains a challenge as genetic drift in naïve population pockets threatens overall vaccine efficacy. In this study, we described the production of insect-cell expressed SARS-CoV-2 spike protein ectodomain and examined its immunogenicity in mice. We demonstrated that, when formulated with CoVaccine HT™adjuvant, an oil-in-water nanoemulsion compatible with lyophilization, our vaccine candidates elicit a broad-spectrum IgG response, high neutralizing antibody titers, and a robust, antigen-specific IFN-γ secreting response from immune splenocytes in outbred mice. Our findings lay the foundation for the development of a dry-thermostabilized vaccine that is deployable without refrigeration.Competing Interest StatementAxel T. Lehrer and Oreola Donini are named inventors on a patent application covering a recombinant subunit vaccine for SARS-CoV-2. David E. Clements and James T. Senda, are current employees of Hawaii Biotech Inc. Laurent Pessaint and Hanne Andersen are current employees of BIOQUAL, Inc. Oreola Donini is a current employee of Soligenix Inc. We declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.