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COVID-19 variant vaccine trial begins recruiting in North Thames

Volunteers in North Thames are being asked to take part in a study using an Oxford/AstraZeneca variant vaccine, aimed at preventing the Beta COVID-19 variant. In the region, the study is taking place at Barts Health NHS Trust and University College London Hospitals NHS Foundation Trust (UCLH).
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 will recruit approximately 1,865 participants across the UK, South Africa, Brazil and Poland, including 800 participants across 14 NIHR sites. UCLH began recruitment on 1 July, while Barts Health will start on 5 July, at its Royal London Hospital site.
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.”
Professor Vincenzo Libri is Principal Investigator of the study at UCLH, where the trial will be conducted at the UCLH Vaccine Research Centre, part of the NIHR UCLH Clinical Research Facility, with the support of the NIHR UCLH Biomedical Research Centre.
Prof Libri said: “It is vital that vaccine research and development keeps pace with the evolution of the virus and the appearance of new variants, so that we can continue to offer sufficient protection to our populations.”
Dr Anju Sahdev, Principal Investigator for the trial at Barts Health, said: “Although the vaccine rollout has been a huge success, we still need more vaccines to ensure as much of the population is as protected as possible against the new and emerging strains.
“At Barts Health, we want to give our local people in east London the opportunity to be part of this important trial.”
The 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.