Trial that recruited up to 30,000 adults over the age of 18 or older to assess the safety, efficacy and immunogenicity of AZD1222 for the prevention of COVID-19
AZD1222 backed by protection and immunogenicity in all age groups
AZD1222 has been expanded to a Phase III clinical trial in the United States to assess its safety, efficacy and immunogenicity.1
The U.S. trial, called D8110C000001, is funded through the Advanced Biomedical Development Authority (BARDA), which is a component of the Office of the Undersecretary of Preparedness and Response (ASPR) in the U.S. Health and Human Services Decomposer (HHS).But it’s not the first time And the National Institute of Allergy and Infectious Diseases (NIAID), which is a component of the U.S. National Institutes of Health, is a member of the World’s National Institutes of Health.Hus And it is administered through AstraZeneca.La COVID-19 Prevention Network (CoVPN) backed by NIAID will take part in the trial.
Mene Pangalos, Executive Vice President, R
Testing centers in the United States recruit up to 30,000 adults aged 18 years of age or more from a variety of racial, ethnic, and geographic teams that are healthy or have strong underlying medical conditions, adding those living with HIV who are most threatened with SARS – CoV-2 infection: outdoor centers in the United States are included based on expected transmission rates of the virus, and sites are expected to be Peru and Chile will begin recruiting shortly.
Participants are randomly assigned to obtain two doses of AZD1222 or control saline, 4 weeks apart, with twice as few participants receiving the vaccine as the control saline solution.The trial assesses the efficacy and protection of the vaccine in all participants, and local and systemic responses and immune responses will be evaluated in 3,000 participants.
The clinical progression of AZD1222 is progressing globally with complex clinical trials underway in the UK, Brazil and South Africa, and trials are expected to begin in Japan and Russia.These trials, along with the US Phase III clinical trial, have been conducted in the united states.Recruit up to 50,000 participants. Complex trial results are expected later this year on the infection rate in clinical trial communities.
In July 2020, the provisional effects of the existing Phase I/II COV001 trial were published in The Lancet and showed that AZD1222 tolerated and generated physically powerful immune responses opposed to SARS-CoV-2 in all participants evaluated.
AstraZeneca continues to work with governments, multilateral organizations and partners around the world to make the vaccine comprehensive and equitable if clinical trials are successful. Announcements from recent sources with Russia, South Korea, Japan, China, Latin America and Brazil provide global source capacity at 3 billion doses of vaccine.
The company undertook to maintain the highest protection criteria and broad and equitable access, reiterating its core values of “following science” and “putting patients first.”
D8110C0000111D8110C000001 is a randomized phase III multicenter exam, a double-blind placebo-controlled exam that compares the safety, efficacy and immunogenicity of AZD1222 compared to placebo for the prevention of COVID-19, in up to 30,000 participants in approximately one hundred interiors and the United States.Trial participants 18 years of age or older who are healthy or have strong chronic diseases and who have a higher threat of exposure to SARS-CoV-2 and COVID-19 will be randomly assigned in a ratio of 2:1 to obtain two intramuscular doses of five x 1010 viral remains of AZD1222 or a 4-week difference saline placebo or a 4-week difference saline placebo , on days one and 29.Randomization will be stratified by age (18 to 18 to
AZD1222AZD1222 co-invented through the University of Oxford and its spin-off company, Vaccitech, uses a poorly replicated chimpanzee viral vector founded on a weakened edition of a bloodless virus (adenovirus) that causes infections in chimpanzees and comprises the genetic tissue of the complex SARS-CoV-2 virus protein.After vaccination, the protein from the tip of the surface is produced, initiating the immune formula to attack the SARS-CoV-2 virus if it then infects the body.
In May 2020, AstraZeneca earned more than $1 billion from BARDA for the development, production and delivery of the vaccine.The Phase III test D8110C00001 is part of this investment agreement.
BARDA, ASPR, HSSHHS works to protect and protect the fitness and well-being of all Americans, offering effective fitness and human conditioning facilities and selling advances in medicine, public fitness and social facilities.The ASPR project is to save lives and protect Americans from physical security threats in the 21st century.Within ASPR, BARDA invests in innovation, complex studies and development, the acquisition and manufacture of medical countermeasures: vaccines, medicines, curative products, diagnostic equipment and non-pharmaceutical products needed to combat threats to physical security.To be more informed about federal aid for the national reaction to COVID-19, stop at coronavirus.gov.
NIAID and CoVPN CoVPN were formed through the NIAID of the U.S. National Institutes of Health.Hus To respond to the global pandemic. Through CoVPN, NIAID leverages the infectious disease expertise and netpaintings commitment of its existing netpaintings studies and global partners to address the urgent need for vaccines and antibodies against SARS-CoV-2.CoVPN will work to expand and conduct studies to ensure an immediate and comprehensive assessment of vaccines and antibodies for COVID-19 prevention.
AstraZeneca AstraZeneca is a global biopharmaceutical company led by science aimed at the discovery, progression and marketing of prescription drugs, mainly for the remedy of diseases in 3 areas of cure: oncology, cardiovascular, renal and metabolism and breathing and immunology.AstraZeneca operates on more than a million patients worldwide using hundreds of countries and their state-of-the-art medicines.For more information, visit www.astrazeneca-us.com and stay with us on Twitter @AstraZenecaUS.
References: 1.Clinicaltrials.gov.A multicenter, randomized, double-blind, placebo-controlled, adult-controlled examination to determine the safety, efficacy and immunogenicity of AZD1222, a vaccine of the non-replicative ChAdOx1 vector, for the prevention of COVID-19.[Online] Available in: https://clinicaltrials.gov/ct2/show/NCT04516746?term=NCT04516746
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