The first participants in a Phase II/III trial for AstraZeneca’s new COVID-19 variant vaccine AZD2816 have been 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.
The same adenoviral vector platform as Vaxzevria
AZD2816 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, AZD2816 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.
AZD2816 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.
“It is important we continue to stay ahead of genetically distinct variants of the coronavirus. AZD2816 should help broaden individuals immune response against emerging variants of concern. Initiating the Phase II/III trial for AZD2816 means we can be prepared should a variant vaccine be required in the future,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
Initial data later this year
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.
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 AZD2816, 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 AZD2816 (5 ×1010 viral particles). In addition, seropositive participants will be enrolled, with a cap of 10% of the seronegative population, to support exploratory analysis.
Photo of Mene Pangalos: AstraZeneca