Abstract
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 preliminary evaluation 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 of this preliminary evaluation suggest that preparation of a whole virion vaccine for COVID-19 using this specific photochemical method may have potential utility in the preparation of one such vaccine candidate.
Highlights
Coronavirus disease 2019 (COVID-19), caused by the virus SARS-CoV-2, continues to spread globally leading to significant impacts on public health [1]
We used shotgun RNA sequencing to confirm the identity of the SARS-CoV-2 isolate used in hamster challenge material and to characterize mutations that may have arisen during cell culture passage [29,30]
We evaluated the ability of a photochemical process for inactivation of pathogens in blood products to use in production of an inactivated SARS-CoV-2 whole virion for prevention of COVID-19 infection
Summary
Coronavirus disease 2019 (COVID-19), caused by the virus SARS-CoV-2, continues to spread globally leading to significant impacts on public health [1]. The emergence of SARS-CoV-2 in human populations spurred the scientific community to development methods to produce vaccines against COVID-19 [3]. Many development paths were initiated using methods that have been applied historically to the production of vaccine candidates as well as new approaches aimed at delivering candidates in a rapid and efficient manner [4]. These methods have included the use of RNA and DNA vaccines, subunit vaccines, attenuated vaccines, as well as vectored vaccines utilizing virus-like particles (VLP), adenovirus or bacterial host constructs. These limitations range from issues in production at scale, cost to produce, stability and delivery process and the potential for side effects
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