Presskit
Presskit
NXV-CoV2373, COVID-19 vaccine candidate - Clinical Trial Plans
- Randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX CoV2373 both adjuvanted and unadjuvanted with Matrix M
- The trial will enroll approximately 130 healthy participants 18 to 59 years of age at two sites in Australia
- Trial participants will receive two vaccinations of either 5 or 25 micrograms with or without Matrix M
Timeline
- May 6th, 2020: Started recruiting volunteers
- May 26th, 2020: Dose first volunteers
- July 2020: Preliminary immunogenicity and safety results
RELATED MEDIA:
Bloomberg coverage of the Novavax COVID-19 vaccine study
IMAGERY: MOVING AND STILL:
app.box.com/v/NovavaxNucleusMediaKit
Images of COVID-19 clinical trial participants undertaking Phase 1 dosing with Nucleus Network
COVID-19 FACTS:
- Coronaviruses, so named for their “crown-like” appearance, are a large family of viruses that spread from animals to humans and include diseases such as Middle East Respiratory Syndrome (MERS) and SARS
- A new strain of coronavirus, SARS-CoV-2, first appeared in late 2019 in China before beginning its rapid spread across the globe. This was later called COVID-19.
- The disease causes severe pneumonia-like symptoms in many of those infected.
- While much remains unknown about the new coronavirus, it is known that the virus can spread via human-to-human transmission before any symptoms appear.
- Population affected: John Hopkins COVID-19 Tracker
Nucleus Network Background Information
Nucleus Network provides 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, Nucleus Network’s cost-effective, accelerated clinical development solutions are supported by advanced technology, clinical excellence, and research expertise.
Nucleus Network is advancing medicine, improving lives.
Company Timeline
- 2003: Nucleus Network established by the Baker ID Heart and Diabetes Institute
- 2018: Sold to Crescent Capital Partners
- 2019: Acquired Q-Pharm (Brisbane, AUS) from QIMR Berghofer Medical Research Institute in February
- 2019: Acquired Prism Clinical Research (Minnesota, US) in August
Locations
Headquartered in Melbourne, with Phase 1 clinics in Melbourne and Brisbane in Australia, and Minnesota in the USA.
- Nucleus Network Melbourne clinic is co-located within the Alfred Research Alliance
- Nucleus Network Brisbane clinic is co-located within the QIMR Berghofer Royal Brisbane and Women’s Hospital precinct
- Nucleus Network Minnesota clinic (Prism Research) is >co-located within the University Enterprise Laboratories medical research precinct
Annual Studies
On an annual basis, Nucleus Network conducts approx. 60 Phase 1 studies in healthy volunteers and patient populations. We regularly conduct vaccine clinical trials.
Facts/Figures:
- Nucleus Network is Australia’s largest Phase 1 clinical trials provider
- Nucleus Network owns 150 beds of the total approximate 250 dedicated Phase 1 beds available in Australia
- We are the only Phase 1 provider in Australia with more than one site (Melbourne and Brisbane)
- We have a database of potential participants of over 100,000 across our three sites.
Strong interest in participating in COVID-19 vaccine studies:
STAFF PROFILES:
Dr Jason Lickliter
As Chief Medical Officer, Dr Jason Lickliter heads Nucleus Network’s Medical Department and a multi-site team of Medical Officers. Jason has extensive experience across all aspects of early phase clinical trials from protocol design and implementation to the integration of Biomarker studies and advanced imaging into clinical research.
With a Medical Oncology and Clinical Hematology background, his achievements include the establishment of a Phase I Cancer Trials Program at Monash Medical Centre.
Dr Paul Griffin
Dr Paul Griffin is an Infectious Diseases Physician and Microbiologist at Nucleus Network’s Brisbane site; where he has overseen more than 100 clinical trials, predominantly in Infectious Diseases. He is the Director of Infectious Diseases at Mater Health Services in Brisbane and Conjoint Associate Professor at the University of Queensland School of Medicine and Affiliate Associate Professor Mater Research Institute.
He has fellowships in Infectious Diseases from the Royal Australasian College of Physicians, in Clinical Microbiology from the Royal College of Pathologists of Australasia and from the Australasian College of Tropical Medicine.
LOGOS:
Download the Nucleus Network logo in a variety of formats
CLINICAL TRIALS:
What is a Clinical Trial?
The World Health Organization (WHO) definition for a clinical trial is ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’.
Clinical trials are designed under Good Clinical Practice principles and are designed, reviewed and approved before they even start. Clinical trials can use healthy volunteers, or be patient based.
Phases of Clinical Trials:
- Phase 1: Safety and tolerance
Phase 1 studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects. - Phase 2: Efficacy and safety
Phase 2 studies test treatments that have been found to be safe in Phase 1 but now need a larger group of human subjects to monitor for any adverse effects. - Phase 3: Safety, efficacy or effectiveness
Phase 3 studies are conducted on larger populations and in different regions and countries and are often the step right before a new treatment is approved. - Phase 4: Post-marketing surveillance or resolution of treatment uncertainties
Phase 4 studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.
BIOTECH IN AUSTRALIA:
Australia is an emerging world-leader in health precincts and bio-tech clusters and is renowned globally for the quality of its medical research.
According to AusBiotech, clinical trials in Australia contribute around $1billion annually to our economy, drawing around $650m of foreign investment from approx. 1000 clinical trials.
WHITE PAPERS
Read more about undertaking Phase 1 clinical trials in Australia during a time of uncertainty