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First COVID-19 variant vaccine AZD 2816 phase II/III trial participants vaccinated.- AstraZeneca

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Published:28th Jun 2021
The first participants in a Phase II/III trial for the new COVID-19 variant vaccine AZD 2816 were vaccinated to assess its safety and immunogenicity in both previously vaccinated and unvaccinated adults. The trial will recruit approximately 2,250 participants across UK, South Africa, Brazil and Poland.

AZD 2816 will be administered to individuals who have previously been fully vaccinated with two doses of Vaxzevria or an mRNA vaccine, at least three months after their last injection. In non-vaccinated individuals, AZD 2816 will be given as two doses, four or twelve weeks apart, or given as a second dose following a first dose of Vaxzevria four weeks apart. AZD 2816 has been designed using the same adenoviral vector platform as Vaxzevria, with minor genetic alterations to the spike protein based on the Beta (B.1.351, South African) variant.

Professor Sir Andrew J Pollard, chief investigator and director of the Oxford Vaccine Group at the University of Oxford, said: “Testing booster doses of existing vaccines and new variant vaccines is important to ensure we are best prepared to stay ahead of the coronavirus pandemic, should their use be needed.”

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.

7220C00001 : D7220C00001 is a Phase II/III partially double-blinded, randomised, multinational, active-controlled trial in both previously vaccinated and unvaccinated adults to determine the safety and immunogenicity of AZD 2816, a vaccine for the prevention of COVID-19 caused by variant strains of the SARS-CoV-2 virus. Trial participants aged 18 years or over who are SARS-CoV-2 nucleocapsid seronegative will be randomised to minimise group differences in terms of age, gender and the presence of comorbidities. Participants will receive intramuscular administration of either Vaxzevria (5 ×1010 viral particles) or AZD 2816 (5 ×1010 viral particles). In addition, seropositive participants will be enrolled, with a cap of 10% of the seronegative population, to support exploratory analysis.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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