SYDNEY, May 26 (Xinhua) -- Australian clinical research organization Nucleus Network announced Tuesday the commencement of dosing the first human participants for the Phase 1 trial of a COVID-19 vaccine on behalf of U.S.-based biotechnology company Novavax.
Novavax is developing the SARS-CoV-2 Recombinant Spike Protein Nanoparticle vaccine -- NVX-CoV2373.
Nucleus Network Infectious Diseases Physician and Microbiologist, Dr Paul Griffin told Xinhua that NVX-CoV2373 had shown great promise in preliminary trials, and despite the fast tracked schedule for testing, was considered safe and displayed a high likelihood of protecting against COVID-19.
"We're as confident, if not more confident with this vaccine about its safety and probability of working, than probably any vaccine ever before," Griffin said.
With 131 volunteers so far, the trial involves participants being injected once with a dose of the vaccine and then again three weeks later, with blood samples taken throughout the study.
During phase one of the clinical trial it is not necessary for the participants to come into contact with the COVID-19. Instead, volunteer's blood samples are tested for the presence of desired antibodies.
"The way we check to see if the vaccine's working is by doing a number of blood tests to look at the antibody levels, if people have the right antibodies, as well as if samples taken from those volunteers will neutralize the virus in test tube studies," Griffin explained.
Phase one results are expected to be available by July, with phase two and three a possibility for before the end of the year.
"Within about four to six weeks of the last volunteer getting the second vaccine, we'll carefully analyze those data to make sure it is indeed safe and looks like it's going to be as effective as we think, and then we'll essentially commence the phase two almost straight away, whilst in parallel planning for the phase three," Griffin said.
According to Griffin, Novavax has already begun planning the large-scale manufacturing of the vaccine should the trials prove successful, with an expected capacity to produce 100 million doses by the end of the year.
He added that should this or any other vaccine prove to be a success, it would most likely be delivered via a risk-based approach.
"So that might be in certain populations, and not necessarily tied to where it's manufactured or trialed, but it might be rolled out to certain populations, and maybe even within that certain at risk individuals, whether it be susceptible people or healthcare workers for example," he said.
