AstraZeneca's COVID-19 vaccine candidate enters Phase III trials in the US

Trial enrolling up to 30,000 adults aged 18 years or over to assess safety, efficacy and immunogenicity of AZD1222 for the prevention of COVID-19.

Trial centres across the US 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.

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.

Participants are being randomized to receive two doses of either AZD1222 or a saline control, 4 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 AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials are 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, depending on the rate of infection within the clinical trial communities.