We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
PURITAN MEDICAL

Download Mobile App





Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine

By HospiMedica International staff writers
Posted on 27 May 2020
Print article
Illustration
Illustration
Novavax, Inc. (Gaithersburg, MD, USA) has begun enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology.

NVX‑CoV2373 includes Novavax’ proprietary Matrix‑M adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Novavax identified NVX‑CoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies. These results provide strong evidence that the vaccine candidate will be highly immunogenic in humans, potentially leading to protection from COVID‑19 and thus helping to control the spread of this disease. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix‑M and without.

The Phase 2 portion is expected to be conducted in multiple countries, including the US, and would assess immunity, safety and COVID‑19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVX‑CoV2373 during the pandemic. The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

“Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.”

“Entering clinical trials is an important step on the path to delivering a safe, effective and globally accessible vaccine against COVID-19,” said Dr. Richard Hatchett, CEO of CEPI. “Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax’ vaccine candidate. CEPI’s priority in building our portfolio has been to focus on vaccine candidates with the potential to be developed at speed and scale and made globally accessible. Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay.”

Related Links:
Novavax, Inc.

Platinum Supplier
Real-Time Diagnostics Onscreen Viewer
GEMweb Live
Specimen Collection & Transport
New
Silver Supplier
ECG Management System
NEMS Web
Gold Supplier
Ultrasound System
FUTUS LE

Print article
Detecto

Channels

Critical Care

view channel
Image: An oil droplet (yellow) stabilized by temperature-sensitive microgels (green) in water (blue) (Photo courtesy of Marcel Rey)

Protected Droplets Could Revolutionize Methods of Targeting Medicines to Specific Body Locations

Emulsions are mixtures consisting of droplets suspended in a liquid where they don’t dissolve or mix. A common example is milk, where fat droplets, stabilized by milk proteins, are dispersed in water.... Read more

Surgical Techniques

view channel
Image: Smart lasers could eventually replace scalpels and saws in surgery (Photo courtesy of University of Basel)

Miniature Laser System Could Accurately Distinguish Tumors from Healthy Tissue

The integration of lasers into ophthalmology since the early 1990s marked a significant technological advancement, and since then, laser technology has expanded its reach into other medical fields.... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The new eye-safe laser technology can diagnose traumatic brain injury (Photo courtesy of 123RF)

Novel Diagnostic Hand-Held Device Detects Known Biomarkers for Traumatic Brain Injury

The growing need for prompt and efficient diagnosis of traumatic brain injury (TBI), a major cause of mortality globally, has spurred the development of innovative diagnostic technologies.... Read more
Copyright © 2000-2023 Globetech Media. All rights reserved.