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Phase III trial enrolling up to 30,000 adults aged 18 years or over to assess safety, efficacy and immunogenicity of AZD 1222 for the prevention of COVID-19.-AstraZeneca
AZD 1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity . 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 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 randomised to receive two doses of either AZD 1222 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 AZD 1222 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. In July 2020, interim results from the ongoing Phase I/II COV001 trial were published in The Lancet and showed AZD 1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
Condition: Coronavirus/COVID-19 Infection
Type: drug