Novavax has called upon the expertise of Nucleus Network to commence Phase 1 clinical trials for its COVID-19 vaccine trials.
As part of the urgent global race to develop a vaccine to tackle the Coronavirus COVID-19 outbreak, Nucleus is due to commence Phase 1 testing for the Novavax SARS-CoV-2 Recombinant Spike Protein Nanoparticle vaccine, NVX-CoV2373, at its Melbourne and Brisbane clinics within the coming weeks.
“Nucleus has a rich history of Phase 1 vaccine trials, and a long-standing track-record with Novavax; we are well positioned to implement rapid testing with first-in-human trials over the coming weeks,” says Nucleus CEO Cameron Johnson.
“With the capacity to conduct this trial across both our Melbourne and Brisbane clinics, we will be assisting Novavax to undertake Phase 1 trials and fast-track NVX-CoV2373 to potential subsequent development as soon as possible,” adds Johnson.
Novavax’s early development efforts on vaccines for two other recent coronavirus epidemics – severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), along with prior work on Ebola – allows them to leverage their understanding of coronaviruses and adapt their research to create a vaccine for SARS-CoV-2, the virus that causes COVID-19.
“The urgent global race to develop a vaccine against the COVID-19 pandemic drove our rapid identification and selection of an optimal, highly immunogenic vaccine candidate,” said Stanley C. Erck, President and CEO of Novavax. “We are pleased that Nucleus, our long-time partner, was able to accommodate our accelerated timeline.”
The Phase 1 trial of NVX-CoV2373 is expected to begin in mid-May with preliminary immunogenicity and safety results in July.
“For all of our clinical trials, Nucleus has implemented the highest level of Transmission-Based Precautions within its clinical units including the creation of dedicated teams of clinical staff,” says Nucleus Infectious Diseases Physician and Microbiologist and, Associate Professor of Medicine at the University of Queensland, Dr Paul Griffin. “These staff are assigned to work only in functional designated areas and there is no cross-pollination of these teams, improving safety, reducing study risk, and ensuring integrity of the trials.”
As a key partner in the development of these promising vaccine candidates, Nucleus’ role in solving the current pandemic is top of mind for Johnson.
“As COVID-19 continues to impact the everyday life of all global citizens, finding a solution has become an urgent objective for governments and health organisations around the world. The world is watching and we’re on the front line, supporting Novavax to unlock the potential of a Coronavirus COVID-19 vaccine.”
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