Press release
Monday, December 28, 2020
The NIH and BARDA-funded study will enroll up to 30,000 volunteers.
The phase 3 trial of another 2019 coronavirus disease vaccine (COVID-19) has begun enrolling adult volunteers. The randomized, placebo-controlled study 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 vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland. Novavax leads the process as a regulatory sponsor. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and the Authority for Advanced Biomedical Research and Development (BARDA), part of the U.S. Department of Health and Human Services under the Assistant Secretary for Preparedness and Training Response, funds the process .
“Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts from the government, academia, industry and the community,” said NIAID Director Anthony S. Fauci, MD. 19 vaccine candidate investigation to be tested in a phase 3 study in the United States – demonstrates our determination to end the pandemic by developing more safe and effective vaccines. “
The process is conducted in collaboration with Operation Warp Speed (OWS), a multi-agency collaboration overseen by HHS and the Department of Defense that aims to accelerate the development, manufacture and distribution of medical measures for COVID-19. Some of the participating US test sites are part of the NIAID-supported COVID-19 (CoVPN) prevention network. CoVPN includes existing clinical research networks supported by NIAID, with expertise in infectious diseases, and was designed for the rapid and thorough evaluation of vaccine candidates and monoclonal antibodies to prevent COVID-19.
Volunteers will be asked to give informed consent before participating in the trial. These will be grouped into two cohorts: people aged 18 to 64 and those aged 65 and over, in order to enroll at least 25% of all volunteers aged 65 or over. Process organizers also emphasize the recruitment of people at higher risk for severe COVID-19 disease, including those who are black (including African-American), Native American, or Latino or Hispanic, and people who are underlying health, such as obesity, chronic kidney disease or diabetes.
“We’ve come this far, so fast, but we need to get to the finish line,” said NIH Director Francis S. Collins, MD, Ph.D. This will require more vaccines using different approaches to ensure that everyone is safely and effectively protected from this deadly disease.
After providing a basic nasopharyngeal and blood sample, participants will be randomly assigned to receive an intramuscular injection of either the investigational vaccine or a saline placebo. Randomization will be in a 2: 1 ratio, with two volunteers receiving the investigational vaccine for each receiving placebo. Because the process is blinded, neither the investigators nor the participants will know who receives the candidate vaccine. A second injection will be given 21 days after the first.
Participants will be closely monitored for potential vaccine side effects and will be asked to provide blood samples at certain times after each injection and for the next two years. Scientists will analyze blood samples to detect and quantify immune responses to SARS-CoV-2, the virus that causes COVID-19. Notably, specialized tests will be used to distinguish between immunity due to natural infection and vaccine-induced immunity. The main objective of the study is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second placebo injection.
The Novavax investigational vaccine, NVX-CoV2373, is made from a stabilized form of coronavirus spike protein using the company’s recombinant protein nanoparticle technology. Purified protein antigens from the vaccine cannot reproduce or cause COVID-19. The vaccine also contains a patented adjuvant, MatrixM ™. Adjuvants are additives that enhance the immune system’s desired 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 the vaccine contains 5 micrograms (mcg) of protein and 50 mcg of adjuvant.
In animal tests, vaccination of NVX-CoV2373 produced antibodies that blocked the coronavirus tip protein from binding to virus-targeted cell surface receptors, preventing viral infection. In the results of a phase 1 clinical study published in New England Journal of Medicine, NVX-CoV2373 was generally well tolerated and generated higher levels of antibodies than those seen in blood samples taken from people who 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 process in the United States and Australia are still awaited. from the first quarter of 2021. Novavax also recently completed the enrollment of over 15,000 volunteers in a Phase 3 study of the UK candidate vaccine, which also tests two injections of 5 mcg of protein and 50 mcg of Matrix-M adjuvant administered at a distance of 21 days.
An independent data and safety monitoring committee (DSMB) will provide oversight to ensure the ethical and safe conduct of the study. All Phase 3 clinical trials of OWS-supported candidate vaccines are monitored by a joint DSMB developed in consultation with the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative.
Adults interested in joining this study can visit Coronaviruspreventionnetwork.org, Novavax.com/PREVENT-19 or ClinicalTrials.gov and search identifier NCT04611802.
About the COVID-19 prevention network: The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Through CoVPN, NIAID uses the infectious disease expertise of its existing research networks and global partners to address the urgent need for SARS-CoV-2 vaccines and antibodies. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies to prevent COVID-19. CoVPN is based at the Fred Hutchinson Cancer Research Center. For more information about CoVPN, visit: coronaviruspreventionnetwork.org.
About HHS, ASPR and BARDA: HHS works to enhance 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 security threats. Within ASPR, BARDA invests in innovation, advanced research and development, the purchase and manufacture of medical countermeasures – vaccines, medicines, therapeutic products, diagnostic tools and non-pharmaceutical products needed to combat health threats. To date, BARDA-supported products have received 55 FDA approvals, licenses or authorizations. To learn more about federal support for the national COVID-19 response, visit www.coronavirus.gov.
About Operation Warp Speed: OWS is a partnership between the components of the Department of Health and Human Services and the Department of Defense, engaging with private companies and other federal agencies and coordinating existing HHS efforts to accelerate the development, production and distribution of COVID-19 vaccines, therapeutic and diagnostic .
About the National Institute of Allergies and Infectious Diseases: NIAID conducts and supports research – at the NIH, throughout the United States and around the world – to study the causes of infectious and immune-mediated diseases and to develop better means of preventing, diagnosing and treating these diseases. Press releases, fact sheets and other materials related to NIAID 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 a component of the US Department of Health and Human Services. NIH is the leading federal agency that conducts and supports basic, clinical, and translational medical research and investigates the causes, treatments, and cures of both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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