News release
Monday, December 28, 2020
NIH and BARDA-funded studies will enroll up to 30,000 volunteers.
The Phase 3 study of another 2019 Coronavirus Disease Study (COVID-19) vaccine has begun enrolling adult volunteers. The randomized, placebo-controlled trial will enroll approximately 30,000 people at approximately 115 sites in the United States and Mexico. It will evaluate the safety and efficacy of NVX-CoV2373, a candidate vaccine developed by Novavax, Inc., of Gaithersburg, Maryland. Novavax is leading the trial as a 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 Office of the Assistant Secretary for Preparedness and Response, fund the trial.
“Tackling the unprecedented COVID-19 health crisis has required extraordinary efforts on the part of government, academia, industry and the community,” said NIAID Director Anthony S. Fauci, MD. “The launch of this study – the fifth research crisis COVID-19 vaccine candidate to be tested in a Phase 3 study in the United States – demonstrates our commitment to ending the pandemic through the development of multiple safe and effective vaccines. “
The trial is being conducted in conjunction with Operation Warp Speed (OWS), a multi-agency partnership overseen by HHS and the Department of Defense that aims to accelerate the development, production and distribution of medical countermeasures for COVID-19. Some of the participating US trial sites are part of the NIAID-supported COVID-19 Prevention Network (CoVPN). The CoVPN encompasses existing NIAID-supported clinical research networks with infectious disease expertise and is designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.
Volunteers will be asked to provide informed consent prior to participating in the study. They are grouped into two cohorts: those aged 18 to 64 and those aged 65 and over, with the aim of enrolling at least 25% of all volunteers aged 65 or older. Trial organizers also emphasize the recruitment of people at higher risk for the serious COVID-19 disease, including black (including African-Americans), Native Americans or of Latino or Hispanic ethnicity, and those with underlying health conditions such as obesity, chronic kidney disease or diabetes.
“We’ve come this far, so fast, but we have to get to the finish line,” said NIH Director Francis S. Collins, MD, Ph.D. “That will require multiple vaccines with different approaches to ensure that everyone is protected safely and effectively from this deadly disease.”
After providing a nasopharyngeal and baseline blood sample, participants will be randomly assigned for an intramuscular injection of either the study vaccine or a placebo with saline solution. Randomization occurs in a 2: 1 ratio, with two volunteers receiving the study vaccine for everyone receiving a placebo. Because the trial is blinded, neither researchers nor participants know who is getting the candidate vaccine. A second injection will be given 21 days after the first.
Participants will be closely monitored for possible side effects of the vaccine and will be asked to provide blood samples at specified times after each injection and for 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. Note that specialized testing will be used to distinguish between immunity due to natural infection and vaccine-induced immunity. The primary endpoint of the study is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second injection as compared to placebo.
Novavax’s research vaccine, NVX-CoV2373, is made from a stabilized form of the coronavirus spike 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 adjuvant, MatrixM ™. Adjuvants are additives that enhance the desired immune system responses to the vaccine. NVX-CoV2373 is administered in liquid form and can be stored, handled, and distributed at temperatures above freezing (35 ° to 46 ° F). A single dose of vaccine contains 5 micrograms (mcg) of protein and 50 mcg of adjuvant.
In animal studies, NVX-CoV2373 vaccination produced antibodies that blocked the binding of the coronavirus spike protein to the cell surface receptors targeted by the virus, preventing viral infection. Results from a phase 1 clinical study published in the New England Journal of MedicineNVX-CoV2373 was generally well tolerated and elicited higher levels of antibodies than those seen in blood samples taken from humans recovered from clinically significant COVID-19. NVX-CoV2373 is also being evaluated in a Phase 2b study in South Africa, now fully enrolled with 4,422 volunteers, and data from a Phase 1/2 follow-up study in the United States and Australia is expected as early as the first quarter of 2021. Novavax also recently completed the enrollment of more than 15,000 volunteers in a Phase 3 study of the vaccine candidate in the United Kingdom, which will also test two injections of 5 mcg protein and 50 mcg Matrix-M adjuvant 21 days apart.
An independent Data and Safety Monitoring Board (DSMB) will oversee to ensure the safe and ethical conduct of the study. All Phase 3 clinical trials of vaccine candidates supported by OWS are monitored by a common DSMB developed in consultation with the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative.
Adults interested in participating in this study can visit Coronaviruspreventionnetwork.org, Novavax.com/PREVENT-19 or ClinicalTrials.gov and search for ID 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 National Institutes of Health in the US 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 wellbeing of all Americans, providing effective health and human services and promoting advancements 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 innovation, advanced research and development, acquisition and manufacturing of medical countermeasures – vaccines, drugs, therapies, diagnostic tools and non-pharmaceutical products needed to combat health security threats. To date, BARDA supported products have achieved 55 FDA approvals, licenses or approvals. To learn more about federal support for the nationwide COVID-19 response, visit www.coronavirus.gov.
About Operation Warp Speed: OWS is a partnership between divisions of the Department of Health and Human Services and the Department of Defense that works with private companies and other federal agencies, coordinating existing HHS-wide efforts to develop, manufacture and distribute COVID-19. accelerate vaccines, therapeutics and diagnostics.
About the National Institute of Allergy and Infectious Diseases: NIAID conducts and supports research – at NIH, in the United States and worldwide – to study the causes of infectious and immune-mediated diseases and to develop better tools to prevent, diagnose and treat these diseases. News releases, fact sheets and other NIAID-related material are available on the NIAID website.
About the National Institutes of Health (NIH):
NIH, the national medical research agency, includes 27 institutes and centers and is part of the United States Department of Health and Human Services. NIH is the premier federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments, and treatments for both common and rare diseases. To learn more about NIH and its programs, visit www.nih.gov.
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