An NHS worker from Manchester University NHS Foundation Trust (MFT) has become the first person in the world to be consented into another leading phase 3 COVID-19 vaccine study, testing the safety and effectiveness of a new two-dose vaccine regimen developed by The Janssen Pharmaceutical Companies of Johnson & Johnson.
Dr Claire Cole, the Head of Research Delivery at MFT – one of the sites where the Janssen Phase 3 trial is being conducted in the UK – was consented into the trial at the site, before later also becoming one of the first in the trial to receive their first dose. Claire was the first of 6,000 volunteers in the UK, and of 30,000 worldwide, to be consented into the trial as researchers around the world continue to work to secure a range of vaccines to help tackle coronavirus.
Claire said: “Although I have worked in health research for a number of years, I never cease to be amazed by the life-changing, and sometimes lifesaving, impact research can have. This has never been truer than during the COVID-19 pandemic, where I have seen first-hand how rapidly clinical research can be translated into treatments for our patients.
“I wholeheartedly believe in the importance of taking part in research and am honoured to be the first person in the world to be recruited to the study, and one of the first to receive the vaccine as part of this vitally important coronavirus vaccine trial.”
Volunteers from a variety of age groups and backgrounds, including some of the thousands who have registered to be contacted about vaccine studies through the NHS COVID-19 Vaccine Research Registry, have begun taking part in the latest study at 17 National Institute for Health Research (NIHR) sites across the UK, including MFT. Recruitment into the study will complete in March 2021 and the study will last for 12 months, with participants being monitored for 24 months after vaccination.
The trial, co-funded by the UK Government’s Vaccine Taskforce, is being delivered in collaboration with the NIHR Clinical Research Network Greater Manchester (CRN GM).
With several more phase 3 studies for potential vaccines expected to start over the next six months, researchers are highlighting the need for volunteers from across the UK to continue to join the fight against coronavirus by taking part in clinical studies by informed choice. In particular, they are encouraging more frontline workers, as well as volunteers from Black, Asian and ethnic minority backgrounds, to join vaccine studies.