AstraZeneca announced that it has submitted a phase III trial of 30,000 patients in the United States on AZD1222, the COVID-19 vaccine it is jointly developing with the University of Oxford and a spinout, a study that will constitute a maximum of the 50,000 participants the company intends to evaluate.
The III assay D8110C00001 (NCT04516746) aims to compare the safety, efficacy and immunogenicity of AZD1222 (formerly ChadOx1 nCoV-19) for the prevention of COVID-19.Participants will be randomly assigned to obtain two doses of AZD1222 or a saline control, 4 weeks apart, with twice as many participants receiving the prospective vaccine as saline control.
Local and systemic responses and immune responses will be evaluated in 3,000 participants, AstraZeneca added.
“If clinical trials show that the vaccine protects against COVID-19 disease and is approved for use, we will strive to make it international as fair and equitably as possible,” said Mene Pangalos, executive vice president of AstraecaZen, R
According to ClinicalTrials.gov, the Phase III trial will be conducted in 62 test centres.These centers, AstraZeneca said, recruit up to 30,000 adults over the age of 18 from a variety of racial, ethnic and geographic teams that are healthy or have a strong history of medical conditions, adding those living with HIV and who are at highest risk of SARS-CoV-2 infection Have been included outdoor centers in the United States based on expected transmission rates of the virus , with sites in Peru and Chile expected to begin recruitment “soon,” the company said.
AstraZeneca said it had complex clinical trials underway in the UK, Brazil and South Africa, and that additional trials are expected to begin in Japan and Russia.In total, the trials will recruit 50,000 participants.
Complex trial results are expected later this year, on the infection rate in clinical trial communities, AstraZeneca said.
AZD1222 is found in a vector of adenovirus vaccine and coVID-19 complex protein.After vaccination, the protein from the tip of the coronavirus surface is produced, which prepares the immune formula to attack the coronavirus if it then infects the body.
AZD1222 is one of 19 “Precursors” applicants among the nearly three hundred COVID-19 treatments studied in the newly introduced “CoVID-19 Drug
Just yesterday, AstraZeneca declared its international “commitment to protection criteria and broad and equitable access” for AZD1222 – and articulated two core values that it believes will govern the development of its vaccine: “Follow science” and “put patients first”.
AstraZeneca also reaffirmed that it had a higher production capacity of AZD1222 to 3 billion doses of vaccine, with advertisements covering Russia, South Korea, Japan, China, Latin America and Brazil.
AZD1222 evolved through the Jenner Institute of the University of Oxford, whose researchers joined in April with colleagues from the University’s Oxford Vaccine Group to initiate clinical progression of the vaccine by launching the Phase I/II COV001 trial (NCT04324606).
Researchers from AstraZeneca, the University of Oxford and their partners published the positive initial knowledge of VOOV001 on 20 July, and appeared that AZD1222 had an appropriate protection profile and favorable immunogenicity opposite the virus.Of the 543 randomized participants to obtain AZD1222, a single dose resulted in a quadruple accumulation of antibodies targeted at the complex SARS-CoV-2 virus protein in 95% of participants on day 28 after injection, the researchers reported.and is maintained two months after the injection.
“The preliminary effects of this first human clinical trial supported the progression of clinical progression to ongoing phase 2 and 3 trials,” the researchers concluded in their study, at The Lancet.
In April, AstraZeneca said it would oversee the development, manufacture and distribution of the vaccine globally, partnering with the University of Oxford to enable the immediate production and distribution of the vaccine if effective in clinical studies.AstraZeneca also signed a licensing agreement with the University.and its spin-off company Vaccitech, which owns the joint rights to the generation of AZD1222 platform.
AstraZeneca is leading the trial, which is funded by the Advanced Biomedical Development Authority (BARDA) and the NIH National Institute of Allergy and Infectious Diseases (NIAID).
BARDA has committed up to $1.2 billion to the development, production and delivery of AZD1222 through Operation Warp Speed, the program through which President Donald Trump’s management committed the country to supplying three hundred million doses of the SARS-CoV-2 vaccine through January 2021.
In addition to the U.S. Phase III trial, BARDA also agreed to fund a trial designed to compare the vaccine in children.AstraZeneca agreed to supply BARDA with three hundred million doses of the vaccine.
It will also participate in the Phase III Phase III Trial of the COVID-19 Prevention Network (CoVPN) backed by NIAID, a network of clinical trials formed in July to recruit thousands of volunteers in large-scale clinical trials for COVID-19 and monoclonal vaccines.. Antibodies.
Through Warp Speed, CoVPN has merged 4 NIAID-funded clinical trial networks for other diseases: Seattle-HIV Vaccine Trials Network (HVTN); THE HIV Prevention Testing Network (HPTN), in Durham, North Carolina; the Atlanta Clinical Infectious Diseases Research Consortium (IDRC); and the Los Angeles AIDS Clinical Trials Group.
Wait while you are redirected to the correct page…