The multidisciplinary collaboration of Bharat Biotech International Ltd (Bharat Biotech), India, ExcellGene SA, Switzerland and the University of Sydney, Australia seeks to establish preclinical and clinical proof of concept for a protein subunit vaccine designed to provide broad protection against all known SARS-CoV-2 variants of concern, as well as future and yet to emerge variants of the virus.
The Coalition for Epidemic Preparedness Innovations (CEPI) is funding the researchers to conduct activities including immunogen design (to trigger a strong immune response), preclinical studies, manufacturing process development and a Phase 1 clinical trial.
Dr Richard Hatchett, CEO of CEPI, said repeated waves of COVID-19 infection remind us we will be living alongside the virus for many years to come.
"The threat of a new variant emerging that might evade the protection of our current vaccines is real, so investing in R&D for variant-proof SARS-CoV-2 vaccines is a global health security imperative. Our partnership with Bharat Biotech, University of Sydney and ExcellGene will advance the development of a vaccine candidate to protect against future variants of COVID-19, potentially contributing to the long-term control of the virus," said Dr Hatchett.
Professor Robyn Ward, Executive Dean and Pro Vice-Chancellor Medicine and Health at the University said: "The University is delighted to partner with CEPI to progress its platform for the development of broadly protective COVID-19 vaccines. Our researchers are at the medical forefront of tackling the COVID-19 pandemic, as well as anticipating what may lie ahead."
The research team: Megan Steain, Jamie Triccas and Claudio Counoupas
Lead University of Sydney investigator Professor Jamie Triccas said the collaboration aims to deliver safe, affordable and highly effective vaccines to combat existing and future SARS-CoV-2 variants.
"Our international consortium is well placed to achieve this goal. The University of Sydney will provide a framework for pre-clinical assessment of vaccine candidates, together with access to Australia's world-class early phase clinical trial community," said Professor Triccas of the Sydney Institute for Infectious Diseases, Faculty of Medicine and Health.
Co-Investigator Dr Megan Steain said the work is important as we will continue to see high levels of circulating virus across the globe and the emergence of new variants with potential to evade pre-existing immunity.
"We aim to create a vaccine that 'future proofs' us against SARS-CoV-2 variants or new betacoronaviruses that may enter the human population. In addition, the vaccine technology we are utilising will bolster the vaccine development landscape in NSW and Australia," said Dr Steain of the Sydney Institute for Infectious Diseases and School of Medical Sciences.
The vaccine design
In this new vaccine design, antigens are created that target multiple SARS-CoV-2 variants, potentially providing broad cross-protection. These novel immunogens will be produced in a cell-based process that permits antigen manufacture at very low cost, with high purity and yield. This strategy could also be used to enable rapid development of broadly protective vaccines against other betacoronaviruses, as well as vaccines against 'disease X'-unknown pathogens with pandemic potential that emerge.
Dr Claudio Counoupas of the Centenary Institute, pre-clinical lead investigator on the project, said the strength of the vaccine platform is that it uses a traditional 'protein-subunit', that involves the combination of antigenic components with immune stimulating adjuvants.
"These protein-subunit vaccines have been in use for decades and have an excellent record in terms of safety and efficacy. In addition, protein subunit vaccines can be stored and transported at ambient temperature and can induce long-lasting immunity," he said.
"The vaccines developed and tested at the University of Sydney could play an important role in the continuing battle to control COVID-19."
Enabling equitable access
CEPI is committed to the principle of equitable access to the vaccines it funds. Under the terms of the funding agreement, the consortium partners have committed to achieving equitable access to the outputs of this project, in line with CEPI's Equitable Access Policy.
Today's announcement is the ninth research program to be funded by CEPI under a $200m programme to advance the development of vaccines that provide broad protection against SARS-CoV-2 variants and other betacoronaviruses. This work forms an important part of CEPI's next 5-year plan which aims to reduce or even eliminate the future risk of pandemics and epidemics.
Declaration: The work that led to this project was supported by the Australian Government Medical Research Future Fund (MRFF).
