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COVID-19 variant vaccine study begins in Plymouth

principle study

Volunteers in Plymouth are taking part in a study using an Oxford/AstraZeneca variant vaccine, aimed at preventing the Beta COVID-19 variant.

The University of Oxford in partnership with AstraZeneca are leading the Phase II/III study, supported by the National Institute for Health Research (NIHR), which will assess the safety and immunogenicity of the variant vaccine in both previously vaccinated and unvaccinated adults.

The study recently opened at Derriford Hospital and is being run by University Hospitals Plymouth (UHP) NHS Trust, with 77 participants having successfully been recruited. Overall, the study plans to recruit approximately 1,865 participants across the UK, South Africa, Brazil and Poland, including 800 participants across 14 NIHR sites.

The new variant vaccine, known as AZD2816 has been designed using the same adenoviral vector platform developed by researchers at the University of Oxford using the ChAdOx platform technology, with ten minor genetic alterations to the spike protein based on the Beta (B.1.351, South African) variant.

The variant vaccine will be administered to those previously fully vaccinated with two doses of original Oxford/AstraZeneca or an mRNA vaccine (Pfizer and Moderna), at least three months after their last injection. AZD2816 will be given as two doses, in non-vaccinated individuals four or twelve weeks apart, or given as a second dose following a first dose of Vaxzevria four weeks apart.

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 pandemic coronavirus, should their use be needed.”

Dr Lucy Leeman, Consultant Immunologist and Principal Investigator for the study locally at UHP, said: “Our local and national vaccination programme has proved a great success so far and is a credit to all those involved. Developing and testing booster vaccines is the next important step in our collective effort against the pandemic.”

Professor Andrew Ustianowski, NIHR Clinical Lead for COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said: "Throughout the pandemic the UK has demonstrated its expertise in clinical vaccine research, consistently supported by the fantastic efforts of tens of thousands of study participants. The latest booster study from Oxford/AstraZeneca is just one of the latest, world-leading steps in our battle to tackle the virus and one of the variants of concern.”

Although local recruitment has ended, the global study is recruiting participants until August, with initial data from the trial expected later this year. Once available, data will be submitted to regulators for assessment as a next-generation booster vaccine and through an expedited regulatory pathway.

Those interested in finding out more about booster vaccine studies and to volunteer to be contacted about taking part in trials can sign-up to the NHS COVID Vaccine Research Registry.

Study volunteers will be recruited across 14 sites in the trial, including:

- University of Nottingham Health Service (Cripps Health Centre)

- North Manchester General Hospital

- Freeman Hospital

- University College Hospital

- Royal London

- Western General Hospital

- St.Thomas' Hospital

- King's College Hospital (Denmark Hill)

- Derriford Hospital

- Churchill Hospital

- Bristol CRF

- Southmead Hospital

- Northern General Hospital

- Hull Royal Infirmary