Press release
Monday, December 28, 2020
The NIH and BARDA-funded trial will enroll up to 30,000 volunteers.
The phase 3 trial of another investigated coronavirus disease vaccine 2019 (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. 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 Allergies and Infectious Diseases (NIAID), which is part of the National Institutes of Health, and the Biomedical Authority for Advanced Research and Development (BARDA), which is part of the Office of the Department of Health and U.S. Human Services Deputy Secretary of Preparedness and Response, are funding the trial.
“Addressing the unprecedented health crisis of COVID-19 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 vaccine candidate COVID-19 to be tested in a phase 3 trial in the United States – demonstrates our decision to end the pandemic by developing multiple vaccines safe and effective.
The test is being conducted in collaboration with Operation Warp Speed (OWS), a multi-agency collaboration overseen by HHS and the Department of Defense that aims to accelerate development, manufacturing, and distribution. of medical countermeasures for COVID-19. Some of the participating U.S. test sites are part of the NIAID-compatible COVID-19 (CoVPN) prevention network. The CoVPN includes existing clinical research networks supported by NIAIDs with experience in infectious diseases and was designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies to prevent COVID-19.
Volunteers will be asked to give informed consent prior to their participation in the test. They will be grouped into two cohorts: people aged 18 to 64 and people aged 65 or over, with the aim of enrolling at least 25% of all volunteers over 65 years. Test organizers also emphasize the recruitment of people at higher risk for serious COVID-19 disease, including black people (including African Americans), Native Americans or Latinos or Hispanics, and people who have underlying health conditions such as obesity, chronic kidney disease, or diabetes.
“We’ve gotten this far, so fast, but we have to get to the finish line,” said NIH Director Francis S. Collins, MD, Ph.D. “This will require multiple vaccines that use different methods to ensure everyone is protected safely and effectively against this deadly disease.”
After providing a nasopharyngeal and initial blood sample, participants will be randomly assigned to receive an intramuscular injection of the research vaccine or a saline placebo. Randomization will be done in a 2: 1 ratio with two volunteers receiving the research vaccine for each receiving a placebo. Because the trial is blind, neither researchers nor 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 possible side effects from the vaccine and will be asked to provide blood samples at the specified 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. It should be noted that specialized trials will be used to distinguish between immunity as a result of a natural infection and vaccine-induced immunity. The primary objective of the trial is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second placebo-related injection.
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. Purified vaccine protein antigens cannot replicate and cannot cause COVID-19. The vaccine also contains a patented 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 testing, NVX-CoV2373 vaccination produced antibodies that blocked the binding of coronavirus ear protein to virus-targeted cell surface receptors, preventing viral infection. In the results of a phase 1 clinical trial published in New England Journal of Medicine, NVX-CoV2373 was generally well tolerated and elicited higher levels of antibodies than those observed in blood samples taken from people who had recovered from a 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 are expected from a phase 1/2 continuation trial in the United States and Australia as early as the first quarter of 2021. Novavax has also recently completed enrollment of more than 15,000 volunteers in a Phase 3 trial of the UK vaccine candidate, which is also testing two injections of 5 mcg of protein and 50 mcg of Matrix-M adjuvant. administered 21 days apart.
An independent Data Control and Security Board (DSMB) will provide oversight to ensure the safe and ethical conduct of the study. All Phase 3 clinical trials of ODS-supported candidate vaccines are overseen by a common 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.
Regarding the COVID-19 prevention network: The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health to respond to the global pandemic. Through CoVPN, NIAID is leveraging the infectious disease experience of its existing research networks and its global partners to address the urgent need for SARS-CoV-2 vaccines and antibodies. CoVPN will work to develop and conduct studies to ensure a rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. CoVPN is headquartered at the Fred Hutchinson Cancer Research Center. For more information about CoVPN, visit: coronaviruspreventionnetwork.org.
As for 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 fostering advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from 21st century security threats. Within ASPR, BARDA invests in advanced innovation, research and development, acquisition and manufacture of medical countermeasures: vaccines, drugs, therapeutic products, diagnostic tools and non-pharmaceutical products needed to combat health security threats. To date, BARDA-compliant products have received 55 FDA approvals, licenses, or authorizations. For more information on federal support for the national COVID-19 response, visit www.coronavirus.gov.
About the Warp Speed operation: OWS is a partnership between components of the Department of Health and Human Services and the Department of Defense, partnering with private companies and other federal agencies, and coordinating existing efforts throughout HHS to accelerate the development, manufacture, and distribution of COVID-19 . vaccines, therapeutics and diagnoses.
About the National Institute of Allergies and Infectious Diseases: NIAID conducts and supports research, at NIH, throughout the United States and around the world, to study the causes of infectious and immune-mediated diseases and to develop better means to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other NIAID-related materials are available on the NIAID website.
Regarding the National Institutes of Health (NIH):
NIH, the country’s medical research agency, includes 27 institutes and centers and is a component of the U.S. 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 for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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