Melbourne, Australia, Tuesday 1st September, Australia’s largest Phase 1 Clinical trials specialist, Nucleus Network, has today commenced dosing the first human participants for the Phase 1/2 trial COVID-19 Vaccine trial in collaboration with the vaccine’s developer Serum Institute of India Pvt. Ltd in partnership with the local sponsor, Accelagen Pty Ltd.
30 healthy participants, aged 18 to 59 years of age, have been screened to take part in Phase 1 of the trial under the guidance of Nucleus Network’s leading expert in infectious disease Principal Investigator Assoc. Professor Paul Griffin. Phase 2 of the trial will include 250 participants and is expected to commence in October.
Victorian Parliamentary Secretary for Medical Research, The Hon. Frank McGuire said today, “Medical research is the key to discovering therapies and hopefully vaccines to fight this new, mysterious virus. Melbourne is the beating heart of Australia’s internationally acclaimed medical research, highlighted by another overseas specialist conducting its trials here.
“From small investments, big ideas can grow. In 2003, the Bracks Government invested $1 million through a Victorian Government Science and Technology Innovation grant into Nucleus Network, which has evolved into an international company, coordinating trials in the global challenge to find a vaccine for COVID-19. The Andrews Government’s last budget invested $116.5 million into medical research to drive new life-saving and life-changing breakthroughs,” said Mr. McGuire.
“Victoria, and Melbourne in particular, is a renowned international epicentre of medical research and this latest trial by Nucleus Network on behalf of the Serum Institute is further evidence of our gold standard biopharma capabilities and the international collaborative effort to find a vaccine,” says Mr. McGuire
Nucleus Network is now administering three of approximately 36 in-human COVID-19 Phase 1 and 2 vaccine trials globally, with The University of Queensland and Novavax also selecting Nucleus Network to conduct their trials. This makes Nucleus one of the only Phase 1 clinical trials specialist entrusted to undertake multiple COVID-19 vaccine trials anywhere in the world.
“Nucleus Network is honoured to help Serum Institute and our other clients work towards a vaccine for the current pandemic,” says Nucleus Network CEO Cameron Johnson. “Nucleus launched 17 years ago and we are now an international company with clinics in Melbourne, Brisbane and Minneapolis, playing a major role in the race for a COVID-19 vaccine.
Serum Institute, which is also the largest vaccine maker in the world by volume, has engaged with the Australian based Contract Research Organisation (CRO), Accelagen Pty Ltd, to determine the optimal clinical trial solution, who in turn selected Nucleus Network as their preferred trial administrator.
“We chose Nucleus Network to conduct the clinical trial due to their reputation, expertise and ability to handle the Phase 1 cohort,” says Greg Plunkett Managing Director at Accelagen. “By working with Nucleus Network, we expect 250 people to take part in the Phase 2 trial of this COVID-19 vaccine.”
“We see this as a promising vaccine candidate for COVID-19,” says Mr. Plunkett. “One of the world’s largest vaccine manufacturers has entrusted Accelagen and Nucleus Network to conduct this very important trial in Australia. If the study successfully meets the objectives and shown to have a positive benefit, this may be a candidate vaccine that could potentially save countless lives around the world and help billions of people return to daily living.”
With the global impact of COVID-19, it is a reflection of the international collaborative effort that Serum Institute is conducting trials in Australia, as well as the expertise and capability of the medical research sector in this country.
Nucleus Network will be leveraging its considerable expertise in delivering clinical trials by recruiting and supporting participants in the trial at the company’s Melbourne and Brisbane purpose-built facilities. Volunteers are recruited from the general public, and the studies would not be possible without their participation.
Nucleus Network Principal Investigator Assoc. Professor Paul Griffin is equally heartened by the latest COVID-19 vaccine trial in Australia and the public’s willingness to participate.
“With this level of support from clients, funding groups, government, and with the willingness of the general public to participate, we can ensure that the trials proceed as soon as possible, without shortening the actual trial process,” he says.
“We have had thousands of people of all ages put their hand up and register to join the clinical trials of this and several other potential vaccines. We could not do this without them, and we appreciate their enthusiasm to participate.”
Nucleus Network is the only multi-site Phase 1 clinical trials provider with facilities located in Australia and the USA. We provide high-quality, first-in-human and early-phase trials for biotechnology and pharmaceutical companies across the USA, Europe and Asia. Located within cutting-edge health precincts, our research expertise, accelerated clinical development solutions are supported by advanced technology and clinical excellence.
Serum Institute of India Pvt. Ltd. is now the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses) which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by the Serum Institute are accredited by the World Health Organization, Geneva and are being used in around 170 countries across the globe in their national immunization programs, saving millions of lives throughout the world.
Serum Institute of India is ranked as India’s No. 1 biotechnology company, manufacturing highly specialized life-saving biologicals like vaccines using cutting edge genetic and cell-based technologies, antisera and other medical specialties.
Accelagen is a world-leading Contract Research Organisation (CRO). Accelagen has been a preferred vendor to a number of large pharmaceutical companies in gene-to-protein contract services, specializing in recombinant protein expression and purification. Since 2006, Accelagen has completed Accelagen is a world-leading Australian based, full-service Contract Research Organisation (CRO), with a focus on clinical research and regulatory affairs. The exceptionally experienced team at Accelagen provides strategic guidance and support throughout all stages of product evolution, including the development, initiation and management of Phase I – IV clinical trials in Australia and New Zealand. Founded in 2010, Accelagen has collaborated with local and international clients, maintaining a dedicated focus to successfully navigate the development pathways.
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