PhIII US trial for AZ' coronavirus vaccine

AstraZeneca has announced the advance of experimental coronavirus vaccine AZD1222 into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity in the prevention of COVID-19.

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 US National Institutes of Health, and led by AZ.

Trial centres across the country are recruiting up to 30,000 adults aged 18 years or over from diverse racial, 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.

Clinical development of AZD1222 – co-invented by the University of Oxford and its spin-out company, Vaccitech – is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials planned to start in Japan and Russia.

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.

In July interim data from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 was tolerated and generated robust immune responses against the virus that causes COVID-19 in all evaluated participants.

The results, published in The Lancet, confirmed that a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection.

Last month AZ finalised an agreement with the European Commission to supply up to 400 million doses of AZD1222, giving give all EU member states the option to access the vaccine “in an equitable manner at no profit during the pandemic”.