The Phase III D8110C00001 trial will evaluate the safety, efficacy and immunogenicity of the AZD1222 vaccine in up to 30,000 adults
AZD1222 expands into US Phase 3 clinical trial. (Credit: pearson0612 from Pixabay.)
AstraZeneca has expanded the clinical development of its potential Covid-19 vaccine candidate AZD1222 in the US, by initiating a Phase 3 clinical trial, dubbed D8110C00001.
The late-stage clinical trial is aimed at evaluating the safety, efficacy and immunogenicity of the AZD1222 vaccine in up to 30,000 adults, aged 18 years or above, across nearly 100 trial centres in and outside the US.
Developed by the University of Oxford and its spin-out company, Vaccitech, AZD1222 leverages a replication-deficient chimpanzee viral vector and contains the genetic material of the SARS-CoV-2 virus spike protein, to induce immune response against the virus.
The company is conducting the clinical trial, with funding from the Biomedical Advanced Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID).
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with BARDA and NIAID to accelerate the development of this vaccine.
“Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”
D8110C00001 will enrol subjects who are at elevated risk of SARS-CoV-2 infection
The D8110C00001 trial is planned to enrol subjects from various racial, ethnic and geographic groups who are at elevated risk of SARS-CoV-2 infection, and randomise them in a 2:1 ratio, either to receive two doses of AZD1222 or saline control, in a span of four weeks.
The clinical trial will enrol patients outside the US, including in Peru and Chile, based on predicted transmission rates of the virus, said the company.
AZD1222’s developmentis being carried out across the world, with late-stage clinical trials underway in the UK, Brazil and South Africa and clinical trials to begin in Japan and Russia.
The clinical trials across the global, including the current US Phase 3 clinical trial, are expected to study up to 50,000 participants across the world.
Interim results from the Phase 1/2 COV001 trial, unveiled in July 2020, demonstrated that AZD1222 was well tolerated, and induced strong immune responses against the SARS-CoV-2 virus in all evaluated participants.
The company has signed several supply agreements with various countries including Russia, South Korea, Japan, China, Latin America and Brazil, to ensure the global supply of its Covid-19 vaccine.