PT  - JOURNAL ARTICLE
AU  - Izabela K Ragan
AU  - Lindsay M Hartson
AU  - Taru S Dutt
AU  - Andres Obregon-Henao
AU  - Rachel M Maison
AU  - Paul Gordy
AU  - Amy Fox
AU  - Burton R Karger
AU  - Shaun T Cross
AU  - Marylee L Kapuscinski
AU  - Sarah K Cooper
AU  - Brendan K Podell
AU  - Mark D Stenglein
AU  - Richard A Bowen
AU  - Marcela Henao-Tamayo
AU  - Raymond P Goodrich
TI  - A whole virion vaccine for COVID-19 produced via a novel inactivation method: results from animal challenge model studies
AID  - 10.1101/2020.11.13.381335
DP  - 2020 Jan 01
TA  - bioRxiv
PG  - 2020.11.13.381335
4099  - http://biorxiv.org/content/early/2020/11/13/2020.11.13.381335.short
4100  - http://biorxiv.org/content/early/2020/11/13/2020.11.13.381335.full
AB  - The COVID-19 pandemic has generated intense interest in the rapid development and evaluation of vaccine candidates for this disease and other emerging diseases. Several novel methods for preparing vaccine candidates are currently undergoing clinical evaluation in response to the urgent need to prevent the spread of COVID-19. In many cases, these methods rely on new approaches for vaccine production and immune stimulation. We report on the use of a novel method (SolaVAX™) for production of an inactivated vaccine candidate and the testing of that candidate in a hamster animal model for its ability to prevent infection upon challenge with SARS-CoV-2 virus. The studies employed in this work included an evaluation of the levels of neutralizing antibody produced post-vaccination, levels of specific antibody sub-types to RBD and spike protein that were generated, evaluation of viral shedding post-challenge, flow cytometric and single cell sequencing data on cellular fractions and histopathological evaluation of tissues post-challenge. The results from this study provide insight into the immunological responses occurring as a result of vaccination with the proposed vaccine candidate and the impact that adjuvant formulations, specifically developed to promote Th1 type immune responses, have on vaccine efficacy and protection against infection following challenge with live SARS-CoV-2. This data may have utility in the development of effective vaccine candidates broadly. Furthermore, the results suggest that preparation of a whole virion vaccine for COVID-19 using this specific photochemical method may have utility in the preparation of one such vaccine candidate.Author Summary We have developed a vaccine for COVID-19 which is prepared by a novel method for inactivation of a whole virion particle and tested it in a hamster animal model for its ability to protect against SARS-CoV-2 infection.