Published: 16 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 which is being delivered by the NIHR, 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.”
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 - will begin taking part in the latest study at 17 NIHR 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.”
Dr Vanessa Apea, a Black, Asian and minority ethnic Clinical Champion at NIHR Clinical Research Network North Thames, and a consultant in Sexual Health and HIV at Barts Health NHS Trust, said:
“We know that these communities are disproportionately affected by COVID-19 and this makes it even more important that any outcomes from research, including new treatments and ways to prevent the disease, work for all communities. Only by doing this can we truly take control of COVID-19, so we really need people from Black, Asian and ethnic minority communities to sign up to learn more and be part of research.”
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.