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 experimental coronavirus vaccine 2019 (COVID-19) started 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 vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland. Novavax is leading the study as a regulatory sponsor. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Advanced Biomedical Research and Development Authority (BARDA), part of the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response , are funding the trial.
“Addressing the unprecedented health crisis in COVID-19 required extraordinary efforts by the government, academia, industry and the community,” said NIAID director Anthony S. Fauci, MD “The launch of this study – the fifth COVID-19 experimental vaccine candidate to be tested in a Phase 3 trial in the United States – demonstrates our determination to end the pandemic by developing several safe and effective vaccines. “
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 the development, manufacture and distribution of medical countermeasures for COVID-19. Some of the participating US test sites are part of the COVID-19 Prevention Network (CoVPN) with NIAID support. CoVPN includes existing networks of clinical research supported by NIAID with experience in infectious diseases and was designed for a rapid and thorough evaluation of candidate vaccines and monoclonal antibodies for the prevention of COVID-19.
Volunteers will be asked to give informed consent before participating in the study. They will be grouped into two cohorts: individuals aged 18 to 64 and those aged 65 and over, with a goal of enrolling at least 25% of all volunteers aged 65 and over. Trial organizers are also emphasizing recruiting people who are most at risk for serious COVID-19 disease, including those who are black (including African-Americans), Native Americans or Latin or Hispanic and people with underlying health problems , such as obesity, chronic kidney disease or diabetes.
“We got here so fast, but we need to get to the finish line,” said NIH director Francis S. Collins, MD, Ph.D. “This will require multiple vaccines using different approaches to make sure everyone is protected safely. and effectiveness against this deadly disease. ”
After providing a nasopharynx and basal blood sample, participants will be randomly assigned to receive an intramuscular injection of the experimental vaccine or a saline placebo. Randomization will be in a 2: 1 ratio with two volunteers receiving the experimental vaccine for each who receives a placebo. Since the study is blind, neither the researchers nor the participants will know who is receiving 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 specific 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. Noteworthy, specialized trials will be used to distinguish between immunity as a result of 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 injection compared to placebo.
Novavax’s experimental vaccine, NVX-CoV2373, is made from a stabilized form of the coronavirus spike protein using the company’s recombinant protein nanoparticle technology. The protein antigens purified in the vaccine cannot replicate and cannot cause COVID-19. The vaccine also contains a proprietary adjuvant, MatrixM ™. Adjuvants are additives that increase 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 zero (35 ° to 46 ° F). A single dose of vaccine contains 5 micrograms (mcg) of protein and 50 mcg of adjuvant.
In animal tests, vaccination with NVX-CoV2373 produced antibodies that blocked the coronavirus spike protein from binding to cell surface receptors targeted by the virus, preventing viral infection. In the results of a Phase 1 clinical trial published in the New England Journal of MedicineNVX-CoV2373 was generally well tolerated and induced higher levels of antibodies than those seen in blood samples collected from people who recovered 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 is expected as early as the first quarter of 2021. Novavax also recently completed enrolling more than 15,000 volunteers in a Phase 3 trial of the candidate vaccine in the UK, which is also testing two injections of 5 mcg of protein and 50 mcg of Matrix-M adjuvant administered with 21 days of interval.
An independent Data and Security Monitoring Board (DSMB) will provide supervision to ensure the safe and ethical conduct of the study. All Phase 3 clinical trials of candidate vaccines supported by OWS are overseen 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 the NCT04611802 identifier.
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 is leveraging infectious disease expertise from 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 a rapid and complete evaluation of vaccines and antibodies for the prevention of COVID-19. CoVPN is headquartered at Fred Hutchinson Cancer Research Center. For more information about CoVPN, visit: coronaviruspreventionnetwork.org.
About HHS, ASPR and BARDA: HHS works to improve and protect the health and well-being of all Americans, providing effective human and health 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 innovation, advanced research and development, acquisition and manufacture of medical countermeasures – vaccines, drugs, therapies, diagnostic tools and non-pharmaceutical products needed to combat threats to health security. To date, BARDA-supported products have achieved 55 FDA approvals, licenses or releases. To learn more about federal support for COVID-19’s national response, visit www.coronavirus.gov.
About the warp speed of the operation: 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 efforts across HHS to accelerate the development, manufacture and distribution of COVID- 19 vaccines, therapies and diagnostics.
About the National Institute of Allergy and Infectious Diseases: NIAID conducts and supports research – at NIH, the United States and around the world – to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose and treat these diseases. Press releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH):
NIH, the country’s medical research agency, includes 27 institutes and centers and is a component of the United States Department of Health and Human Services. NIH is the leading federal agency that conducts and supports basic, clinical and translational medical research, and is investigating 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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