25 May 2020
Australia’s largest Phase 1 Clinical trials specialist, Nucleus Network, has commenced dosing the first human participants for the Phase 1/2 trial of NVX CoV2373, a SARS-CoV-2 Recombinant Spike Protein Nanoparticle vaccine, at its Melbourne clinic
Nucleus Network has begun the Phase 1/2 COVID-19 vaccine trial in Australia on behalf of Novavax, Inc., the developer of NVX-CoV2373 and sponsor of the trial, with funding support from the Norway-based Coalition for Epidemic Preparedness Innovations (CEPI), joining the global response to this pandemic.
Victorian Parliamentary Secretary for Medical Research, The Hon. Frank McGuire, formally launched the Novavax trial with Nucleus Network in Melbourne today, saying this was a significant step forward in the race for a vaccine.
Vaccines are one of mankind’s greatest achievements in saving lives and livelihoods.
As the first human trial in the southern hemisphere, and one of only a handful of COVID-19 human trials worldwide, I am delighted Victoria is again at the forefront in leadership and excellence in medical research. The combination of expertise, institutional clout and commitment is vital in the race for a reliable, safe, and effective vaccine. We hope these trials make a significant contribution to the discovery of a vaccine that would ultimately benefit hundreds of millions of people around the world.
The Hon. Frank McGuire
Nucleus Network Melbourne initiated the Phase 1 portion of the Phase 1/2 trial on 26 May 2020 with additional dosing at its Brisbane clinic. Approximately 130 healthy participants, aged 18 to 59 years of age, in Melbourne and Brisbane have been screened to take part in this portion of the Novavax trial. The trial will be under the guidance of leading medical experts in clinical trials including Nucleus Network Chief Medical Officer, Dr. Jason Lickliter, and Nucleus Network Infectious Diseases Physician and Microbiologist Dr. Paul Griffin.
NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology and contains Novavax’ patented saponin-based Matrix M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. This is considered a critical aspect for effective vaccine protection and offers a promising avenue for vaccine development.
Novavax received the largest investment to date given by CEPI, up to USD$388 million, to advance NVX CoV2373, through Phase 2 clinical trials.
Novavax responded rapidly to the COVID-19 pandemic to create an optimal vaccine candidate and quickly advance it into a Phase 1 clinical trial. We thank our employees and partners, including Nucleus, who continue to work tirelessly to advance this important research and the trial participants who have volunteered for the benefit of many others around the world
Stanley C. Erck, President and Chief Executive Officer of Novavax
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.
As Australia’s largest Phase 1 clinical trials specialist, we have a rich history of delivering Phase 1 vaccine trials, and a long-standing track record with Novavax. This trial offers the first critical step into creating a potential vaccine that is safe and able to be accelerated into the next phase of development.
Nucleus Network Infectious Diseases Physician and Microbiologist Dr. Paul Griffin
With extensive COVID-19 safety measures in place to cover its clinical operations and participant recruitment, Nucleus Network continues to successfully deliver Phase 1 clinical trials during the current pandemic.
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. These staff are assigned to work only in functional designated areas and there is no cross-pollination of these teams, improving safety for our staff and participants, reducing study risk, and ensuring the integrity of the trials.
Nucleus Network CEO Cameron Johnson
The decision from Novavax to select Nucleus Network is a significant milestone for the Australian clinical trials ecosystem. We still have a long way to go, but we’re proud to be a part of the team to deliver a safe, effective, and globally accessible vaccine as quickly as possible.