COVID-19 Vaccine Updates: South Australia’s Flinders University Commences Phase 1 Trial Of COVID-19 Vaccine COVAX-19 Developed By Vaxine Pty Ltd
COVID-19 Vaccine Updates
: It was announced that vaccine candidate COVAX-19 developed by Vaxine Pty Ltd and Flinders University will commence Phase 1 trials at the Royal Adelaide Hospital (RAH) to test its efficacy.
The phase I trial will provide initial safety and immune response data on 40 healthy participants aged between 18 and 65 years who have already been pre-screened.
Research participants with receive two doses, three weeks apart, of the new vaccine or a placebo injection and will then have blood tests to measure protective antibody and T-cell responses induced by the vaccine.
The WHO (World Health Organization) lists more than 120 COVID-19 vaccine projects in either preclinical or early human clinical trials, with several others in Australia also closing in on possible human testing.
Professor Dr Nikolai Petrovsky from Flinders University and chairman and research director of Vaxine, says the first Southern Hemisphere human trials of a SARS-CoV-2 (COVID-19) vaccine candidate is based on the company's recombinant spike protein approach.
The South Australia’s COVAX-19®
vaccine was developed from Vaxine's earlier SARS coronavirus vaccine approach, which combines with Vaxine's non-inflammatory Advax-CpG55.2 adjuvants.
Previous experience with adenovirus-based vaccines has shown disappointing protection and high toxicity and DNA and mRNA type vaccines have their own problems, including being unproven technologies that may still turn out to be poorly scalable or have unexpected side effects. Low immunogenicity of adenovirus, DNA and mRNA technologies in particular could be a major problem when it comes to coronavirus vaccines, where immunity will need to be strong and long-lasting.
Dr Petrovsky added, “Most of these vaccine technologies are unable to benefit from adjuvants, which are the key turbochargers that are bolted onto protein-based vaccines to dramatically enhance their effectiveness."
The new vaccine model was developed with artificial intelligence (AI), and received support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health under NIAID Contracts HHSN272200800039C, HHSN272201400053C, and HHSN27221800024C.
Dr Petrovsky explains long-term financial support is required to build a robust pandemic vaccine platform and advance it into human trials.
He said, "Pandemic vaccine development is of paramount public health importance. Research in this area should not be something you can turn on and off like a tap."
Flinders University Professor Dr David Gordon, a microbiologist and infectious diseases physician with SA Pathology and principal investigator on the potential vaccine, says the trial is the first of several planned and involves testing the safety and immune responses to the vaccine.
Dr Gordon added, "This COVID-19 vaccine has already shown promising results in animal models, so it is exciting to take this national breakthrough to human trials in Adelaide. The development of antibodies and other immune responses will be determined two weeks after the second injection, so the re
sults of the first trial will available in around two months' time."
Clinical Immunologist from Royal Adelaide Hospital, Dr Pravin Hissaria says the trial participants' involvement was a vital component of the medical research to find a vaccine.
Dr Hissaria said, "Now, members of the Adelaide public have stood up to be amongst the first people in the world to receive a trial vaccine. Their actions could help us find a permanent solution to this devastating global pandemic."
Only after health checks are run on the first volunteer, the other participants will be called in a week to receive the vaccine at PARC Clinical Research center at the RAH. After assessments, Phase 2 clinical trials will be scheduled for further testing later this year.
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