News Release
Monday 28 December 2020
NIH and BARDA funded trials will enroll up to 30,000 volunteers.
The Phase 3 trial of another coronavirus 2019 vaccine (COVID-19) has begun enrolling adult volunteers. The randomized, placebo-controlled trial will enroll approximately 30,000 people in approximately 115 locations in the United States and Mexico. This will evaluate the safety and efficacy of NVX-CoV2373, a vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland. Novavax leads the trial as the regulatory sponsor. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, the Assistant Secretary for Preparedness and Response funding the trial.
“Addressing the unprecedented health crisis of COVID-19 requires extraordinary effort from government, academia, industry and the community,” said NIAID Director Anthony S. Fauci, MD. “The launch of this study – the fifth COVID-19 research vaccine candidate to be tested in a Phase 3 trial in the United States – shows our determination to end the pandemic by developing multiple safe and effective vaccines.”
The trial is being conducted in collaboration with Operation Warp Speed (OWS), a collaboration with multiple agencies overseen by HHS and the Department of Defense, which aims to develop, manufacture and distribute medical countermeasures for COVID -19 to speed up. Some of the participating U.S. trial sites are part of the NIAID-supported COVID-19 Prevention Network (CoVPN). The CoVPN contains existing NIAID-supported clinical research networks with expert infectious diseases and is designed for a rapid and thorough evaluation of vaccine and monoclonal antibody candidates to prevent COVID-19.
Volunteers will be asked to give informed consent before participating in the trial. They will be grouped into two groups: individuals aged 18 to 64 and those aged 65 and over, with the aim of enrolling at least 25% of all volunteers aged 65 or over. Trial organizers also emphasize the recruitment of people at higher risk for serious COVID-19 diseases, including those who are black (including African Americans), Native Americans, or Latino or Hispanic ethnicity, and people with underlying health conditions such as obesity , chronic kidney disease or diabetes.
“We came so fast, but we have to get to the finish line,” said NIH Director Francis S. Collins, MD. “For that, several vaccines are needed to use different approaches to ensure that everyone is protected safely and effectively against this deadly disease.”
After a nasopharyngeal and blood sample is given at the beginning, the participants will be randomly assigned to receive an intramuscular injection of the test vaccine or a saline solution. Randomization will be in a 2: 1 ratio, with two volunteers receiving the study vaccine for each receiving placebo. Because the trial is blinded, investigators or participants will not know who is receiving the candidate vaccine. A second injection will be given 21 days after the first application.
Participants will be closely monitored for possible side effects of vaccines and will be asked to give blood samples at specific time after each injection and during the next two years. Scientists will analyze the blood samples to detect and quantify immune responses to SARS-CoV-2, the virus that causes COVID-19. It is noteworthy that specialized tests are used to distinguish between immunity due to natural infection and immunity-induced immunity. The primary endpoint of the trial is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second injection compared to placebo.
Novavax’s research vaccine, NVX-CoV2373, is made from a stabilized form of the coronavirus ear protein using the company’s recombinant protein nanoparticle technology. The purified protein antigens in the vaccine cannot replicate and cannot cause COVID-19. The vaccine also contains its own tool, MatrixM ™. Aids are additives that enhance the desired immune system response to vaccine. NVX-CoV2373 is administered in liquid form and can be stored, handled and distributed at freezing point (35 ° to 46 ° F). A single dose of vaccine contains 5 micrograms (mcg) of protein and 50 mcg of additive.
In animal tests, the NVX-CoV2373 vaccine produced antibodies that blocked the coronavirus ear protein to bind to the cell-surface receptors targeted by the virus, preventing virus infection. In the results of a phase 1 clinical trial conducted in the New England Journal of MedicineNVX-CoV2373 is generally well tolerated and elicited higher levels of antibodies than those seen in blood samples drawn from people recovering from clinically significant COVID-19. NVX-CoV2373 is also being evaluated in a Phase 2b trial in South Africa, now fully enrolled with 4,422 volunteers, and data from a Phase 1/2 continuation trial in the United States and Australia are already in the first quarter of 2021 expect. Novavax is also expected to have recently enrolled more than 15,000 volunteers for a Phase 3 trial of the candidate vaccine in the UK, which is also testing two injections of 5 mcg protein and 50 mcg Matrix-M adjuvant that are 21 days apart applied.
An Independent Data and Security Monitoring Board (DSMB) will oversee the safe and ethical conduct of the study. A general DSMB developed in consultation with the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative oversees all Phase 3 clinical trials with candidate vaccines supported by OWS.
Adults interested in joining this study may visit Coronaviruspreventionnetwork.org, Novavax.com/PREVENT-19 or ClinicalTrials.gov and search the search identifier NCT04611802.
About the COVID-19 Prevention Network: The COVID-19 Prevention Network (CoVPN) was established by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health to respond to the global pandemic. Through the CoVPN, NIAID leverages the infectious disease expertise of its existing research networks and global partners to address the urgent need for vaccines and antibodies against SARS-CoV-2. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. The CoVPN is headquartered at the Fred Hutchinson Cancer Research Center. For more information about the CoVPN, visit: coronaviruspreventionnetwork.org.
About HHS, ASPR and BARDA: HHS works to improve and protect the health and well-being of all Americans, by providing effective health and human services and promoting advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from 21st century health threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition and manufacturing of medical countermeasures – vaccines, medicines, therapies, diagnostic tools and non-pharmaceutical products needed to combat health and safety threats. To date, BARDA products have obtained 55 FDA approvals, licenses or approvals. Visit www.coronavirus.gov for more information on federal support for the nationwide COVID-19 response.
About Operation Warp Speed: OWS is a partnership between components of the Department of Health and Human Services and the Department of Defense, with private companies and other federal agencies, and coordinates under existing HHS-wide efforts to accelerate the development, production and distribution of COVID-19 . vaccines, therapy and diagnostics.
About the National Institute of Allergy and Infectious Diseases: NIAID conducts and supports research – at NIH, across the United States and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better ways to prevent, diagnose, and treat these diseases. News reports, fact sheets and other NIAID related material are available on the NIAID website.
About the National Institutes of Health (NIH):
NIH, the country’s medical research agency, contains 27 institutes and centers and is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments, and drugs for common and rare diseases. Visit www.nih.gov for more information on NIH and its programs.
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