UK wide COVID-19 study recruits the first global patient in Dundee
17th November 2020
A phase 3 trial for the COVID-19 vaccine developed by The Janssen Pharmaceutical Companies of Johnson & Johnson has this week recruited the first global patient in Dundee.
This latest study, co-funded by the UK government’s Vaccine Taskforce, and being delivered across the UK will recruit 30,000 people worldwide. It will test the safety and effectiveness of a new vaccine with two doses called ENSEMBLE 2.
James Brook, Head of Clinical Delivery, UK and Ireland at Iqvia said:
"Iqvia is delighted that the first of 30,000 volunteers has been recruited in the UK which highlights our shared commitment and capability to work collaboratively at speed with the Vaccine Task Force, NIHR, and our regulatory and ethics authorities. We are proud to be delivering the highest standards of care and patient engagement at an unprecedented pace, leading the world through a combined capability of industry and government in our joint ambition to support and protect patients and public in the UK and Ireland against COVID-19.”
Professor Jacob George, Director of R&D NHS Tayside said:
"Dundee is pleased to be part of the ENSEMBLE-2 trial. Our team have worked incredibly hard to ensure the study was up and running in a very short time frame. We are delighted to have recruited the first global patient to this trial but the hard work of fully recruiting to target has only just begun. We require the full support of the public to ensure we achieve recruitment targets and meaningful results."
Volunteers from a variety of age groups and backgrounds - including those who have registered to be contacted about vaccine studies through the NHS COVID-19 Vaccine Research Registry - began taking part in the study from Monday 16 November at 17 sites across the UK. These include Southampton, Bristol, Cardiff, London, Leicester, Sheffield, Manchester, Dundee and Belfast. Recruitment into the study will complete in March 2021 and the study will last for 12 months.
Dr. William van’t Hoff, Chief Executive Officer at the NIHR Clinical Research Network said:
“It is really great news to see the rapid development of vaccines like this one, achieving the phase 3 stage, when the vaccine is compared with a placebo to assess its effectiveness. Although we have heard last week of another effective vaccine, there is still much to be done before that might be used and, importantly, we must have a range of vaccines to tackle COVID-19. We are studying a range of vaccines that work in different ways and it is really important to test these in the UK. In particular, we want to offer the vaccine studies to more frontline workers, those over 65 as well as volunteers from Black, Asian and ethnic minority backgrounds. So I would urge people to consider signing up to the vaccine registry to be contacted about vaccine trials happening near them.”
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson said:
"We are delighted to be initiating our global Phase 3 trial in the UK to study the safety and efficacy of a two-dose regimen of our investigational COVID-19 vaccine candidate. This collaboration with UK researchers and the NIHR demonstrates our continued commitment to working together with partners around the world, and marks another positive step forward as we strive to find solutions to this global health crisis.”
The NHS Vaccine Registry was launched by the government in partnership with the NIHR, NHS Digital, the Scottish and Welsh governments and the Northern Ireland Executive in July. It aims to help create a database of people who consent to be contacted by the NHS to take part in clinical studies, to help speed up the development of a safe and effective vaccine.
For more details and to sign up, visit: www.nhs.uk/researchcontact.