The Phase II/III trial, sponsored and led by AstraZeneca will recruit approximately 2,250 participants across UK, South Africa, Brazil and Poland. AZD2816 will be administered to individuals who have previously been fully vaccinated with two doses of the original Oxford-AstraZeneca vaccine or an mRNA vaccine, at least three months after their last injection. In non-vaccinated individuals, AZD2816 will be given as two doses, four or twelve weeks apart, or given as a second dose following a first dose of original Oxford-AstraZeneca vaccine four weeks apart. For the UK booster study launch participants must have received two doses of an approved COVID-19 vaccine three to 12 weeks apart more than three months prior to the study. Initial data from the trial is expected later this year and, once available, will be submitted to regulators for assessment as a next-generation booster vaccine and through an expedited regulatory pathway.
