COVID-19 variant vaccine begins recruiting in Newcastle
Volunteers in Newcastle are being invited to take part in a study which will assess how safe and effective an updated version of the Oxford/AstraZeneca vaccine will protect against the COVID-19 South African variant.
A new variant vaccine, known as AZD2816, has been developed by researchers at the University of Oxford using the same technology that was used in the ChAdOx vaccine which has been rolled out in the UK and internationally since early 2021. This uses an inactivated adenovirus vector to expose the human immune system to proteins from SARS-CoV-2, the coronavirus that causes COVID-19, in order to generate a protective immune response.
The new AZD2816 vaccine has ten minor genetic alterations to the spike protein, designed to improve immune responses to the B.1.351 strain, commonly known as the South African or Beta variant.
The University of Oxford in partnership with AstraZeneca are leading this Phase II/III study, supported by NIHR, which will recruit both 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, with The Freeman Hospital in Newcastle hoping to recruit between 50 and 70 participants.
All participants in Newcastle will have been fully vaccinated with two doses of the original Oxford/AstraZeneca vaccine, will have received their last injection at least three months before entering the study, and will be given a single dose of the AZD2816 boosting vaccine.
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 Caroline Wroe, Clinical Director for NIHR Clinical Research Network North East and North Cumbria said: “It is important that our vaccine research continues. We have had a tremendously successful vaccine roll out in the UK and this study will help us understand future protection against new variants. I am delighted that we are able to offer this opportunity to local participants at the Freeman Hospital.”
Dr Ewan Hunter, Consultant in Infectious Diseases and Principle Investigator of the study at The Newcastle upon Tyne Hospitals NHS Foundation Trust said: “It is fantastic to bring another opportunity for people in Newcastle and the surrounding area to participate in a COVID-19 vaccine study. It is vital that booster vaccine research happens as this will help to ensure that we can continue to protect people from COVID-19.”
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 other research can visit www.bepartofresearch.nihr.ac.uk
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