University of Maryland School of Medicine Begins Phase 3 Trial of Novavax COVID-19 Vaccine Candidate
Monica McArthur, MD, PhDResearchers at the University of Maryland School of Medicine (UMSOM) will participate in a Phase 3 clinical trial of an investigational COVID-19 vaccine to protect against SARS-CoV-2, the coronavirus causing COVID-19 that continues to impact millions of people around the world. The clinical trial will test the safety and effectiveness of NVX-CoV2373, being developed by U.S. biotechnology company, Novavax, Inc., based in Gaithersburg, MD.
The vaccine trial is being conducted by researchers in UMSOM’s Center for Vaccine Development and Global Health (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.
Karen Kotloff, MDThe principal investigator for this vaccine trial at the UMSOM is Monica McArthur, MD, PhD, Assistant Professor of Pediatrics. Karen Kotloff, MD, Professor of Pediatrics, is Co-Chair for the trial protocol, which will be implemented at multiple sites across the country and Mexico, and plans to enroll up to a total of 30,000 adults. The UMSOM site is expected to recruit up to 500 participants.
The clinical trial at UMSOM’s Center for Vaccine Development and Global Health aims to enroll the 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.
“This virus has not been democratic. We have seen that it has impacted minorities, the elderly, and people with certain medical conditions the hardest, and so an important goal of this research is to learn about the safety and effectiveness of the vaccine in these groups,” said Dr. Kotloff, who is Associate Director for Clinical Research in CVD and principal investigator of the Vaccine Treatment and Evaluation Unit.
A key component of this research includes UMSOM’s efforts is to enroll participants in Maryland’s communities most impacted by the coronavirus, including Langley Park and Baltimore.
“We know this virus disproportionately affects older adults, those with unstable medical conditions, and racial and ethnic minorities, which makes it all the more imperative that the vaccine works well in those who need it most,” said Dr. McArthur.
The Novavax trial is part of Operation Warp Speed, a multi-agency collaboration led by the U.S. Department of Health and Human Services (HHS), which aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. Under Operation Warp Speed, thousands of volunteers are enrolled in various large-scale clinical trials, testing a variety of investigational vaccines intended to protect people from COVID-19.
Kathleen Neuzil, MD MPH, FIDSA“Our CVD team is contributing to the advancement of several promising COVID vaccine candidates. Our researchers are working to ensure that the safety and performance of these vaccines is meticulously assessed,” said Kathleen Neuzil, MD, MPH, FIDSA, the Myron M. Levine, MD, DTPH Professor of Vaccinology and Director, Center for Vaccine Development and Global Health. Dr. Neuzil is a co-director of the COVID-19 Prevention Trials Network, which brings together experts from existing NIAID-supported clinical research networks to fight COVID-19.
About the Vaccine
The Novavax vaccine candidate, NVX-CoV2373, is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and is adjuvanted with Novavax’ proprietary MatrixM™. NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.
The vaccine is already 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, although the timing depends on the overall COVID-19 rate in the region.
E. Albert Reece, MD, PhD, MBA“Our COVID-19 experts at the University of Maryland School of Medicine have been at the forefront of vaccine research. This research -- which builds upon extensive COVID-19 vaccine and therapy research that has been underway for several months -- will lead us a step closer to licensure and impact millions of people,” said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine.
About the Phase 3 Trial
The Phase 3 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of the vaccine in participants aged 18 and older. Two thirds of the participants will receive two intramuscular injections of the vaccine administered 21 days apart and the other third will receive a placebo.
The trial is designed to enroll at least 25 percent of participants ages 65 and older, as well as to prioritize groups who are most affected by COVID-19, including racial and ethnic minorities.
Participants will be followed carefully to assess the safety of the vaccine and its ability to prevent COVID-19 with frequent telephone calls and completion of smart phone diaries. They will be asked to provide a nasal swab and a blood sample at an initial screening visit, as well as at several time points after each vaccination and over the next two years after the second vaccination. Scientists will examine blood samples in the laboratory to better understand the immune responses to SARS-CoV-2 that provide protection.
About the University of Maryland School of Medicine
Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 45 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $540 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System (“University of Maryland Medicine”) has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community. The School of Medicine faculty, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu.