Researchers at the University of Maryland School of Medicine (UMSOM) have found promising results in preclinical studies for a new experimental vaccine against COVID-19 made by Novavax.
The vaccine was found to generate a robust immune response in animals exposed to the vaccine with strong data indicating safety and efficacy, according to the study published recently in the journal Nature Communications. The results have been used to begin testing the vaccine in human trials in the United States with a Phase 3 trial that recently launched at UMSOM’s Center for Vaccine Development and Global Health (CVD).
The vaccine is a stable protein that is manufactured from the genetic sequence of the SARS-CoV-2 coronavirus spike protein. As with traditional vaccines like the flu shot, the Novavax vaccine uses adjuvants to boost the immune response in those who receive it.
“We found this vaccine produces high antibody levels leading to significant protection from SARS-CoV-2 in mice. Together with the non-human primate data, this suggests that the vaccine will be highly protective in humans. Our previous work, with Novavax on a MERS coronavirus vaccine and now SARS-CoV-2, demonstrates that continued support of basic science is essential in the response to pandemics,” said study co-author Matthew Frieman, PhD, associate professor of microbiology and immunology at UMSOM.
The vaccine trial is being conducted by researchers in UMSOM’s CVD as part of their National Institute of Allergy and Infectious Diseases-funded Vaccine Treatment and Evaluation Unit (VTEU), and the COVID-19 Prevention Network (CoVPN). It adds to the extensive COVID-19 vaccine research that has been underway on campus since early spring. The UMSOM site is in the process of recruiting up to 500 participants out of 30,000 total who will take part in the trial. The aim is to include diverse populations most impacted by COVID-19. They will include people who have increased risk of exposure because of location or circumstance, such as occupation. Individuals 65 and older, African Americans and LatinX populations, as well as individuals at risk of severe COVID-19, will be represented.
The Novavax vaccine candidate, NVX-CoV2373, is a stabilized, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and is formulated with Novavax’s proprietary adjuvant Matrix‑M™. NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.
The vaccine has been in Phase 3 trials in the U.K., with more than 15,000 participants enrolled. Interim data in this event-driven trial are expected as soon as early first quarter of 2021.
“Our coronavirus experts at the University of Maryland School of Medicine have been at the forefront of basic research efforts that have helped develop new treatments and vaccines against COVID-19,” said E. Albert Reece, MD, PhD, MBA, executive vice president for medical affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and UMSOM dean. “For this new vaccine made by Novavax, our researchers have worked on every aspect of its development from bench studies to Phase 3 clinical trials. It speaks to the broad expertise and collaborative efforts of our faculty. This latest research will lead us a step closer to providing another potentially lifesaving tool in the vaccine arsenal.”