A new arm of the ongoing global clinical trials of the ChAdOx1 nCoV-19 vaccine led by AstraZeneca has launched in the US to assess safety, efficacy and immunogenicity of the vaccine for the prevention of COVID-19.
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The US trial called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.
Trial centres across the US are recruiting up to 30,000 adults aged 18 years or over from diverse ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. Centres outside the US are included based on predicted transmission rates of the virus and sites in Peru and Chile are planned to initiate recruitment shortly.
‘Oxford and AstraZeneca are collaborating with clinical partners around the world as part of a global clinical programme to trial the Oxford vaccine. This latest trial in the US, led by AstraZeneca, will expand our safety database further and will help to provide the possibility of an earlier understanding of whether the vaccine can prevent infection,’ said Professor Andrew Pollard, Chief Investigator of the Oxford Coronavirus Vaccine Trials (UK, Brazil and South Africa) and Director of the Oxford Vaccine Group.
Participants are being randomised to receive two doses of either ChAdOx1 nCoV-19 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.
Clinical development of ChAdOx1 nCoV-19 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa, led by Professor Pollard of Oxford University, and trials are planned to start in Japan and Russia, led by Astra Zeneca. These trials, together with the US Phase III clinical trial will enrol up to 50,000 participants globally. Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.
In July 2020, interim results from the ongoing Phase I/II COV001 trial were published in The Lancet and showed ChAdOx1 nCoV-19 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, 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.’
Oxford’s partner for manufacture and supply of the vaccine, AstraZeneca, continues to engage with governments, multilateral organisations and partners around the world to ensure broad and equitable access to the vaccine, should clinical trials prove successful. Their recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil take the global supply capacity towards three billion doses of the vaccine.