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Urgent call for volunteers across the West of England to take part in a new COVID-19 vaccine study

Last updated: 03/12/2020

Volunteers from across the West of England are being called upon to join another leading phase 3 COVID-19 vaccine study, as researchers around the world continue to work to secure a range of vaccines to help tackle coronavirus.

Phase 3 studies involve many thousands of people, giving researchers insights into the effects of a vaccine on a much larger population than phase 1 and 2 studies.

The latest study, co-funded by the UK government’s Vaccine Taskforce, will test the safety and effectiveness of a new two-dose regimen for a vaccine candidate developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The study, which will recruit up to 30,000 people worldwide, will last for 12 months, with recruitment completing in March 2021.

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, will soon be contacted about taking part in this study. People from the West of England who are interested in taking part in the Janssen ENSEMBLE 2 vaccine study can register their interest by completing the pre-screening questionnaire on the ENSEMBLE website.

In the West of England the vaccinations will take place in Bristol, at University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) and North Bristol NHS Trust, with follow up happening locally for participants from Bath, Swindon and Gloucestershire.

Dr Rajeka Lazarus, a consultant in infectious diseases and microbiology at UHBW and Principal Investigator for vaccine studies in the West of England said:
“Vaccines are the most effective way of controlling COVID-19, and the announcement of this latest vaccine study in the West of England is another step towards finding a safe and effective solution for the virus.

“While the progress being made is positive, we need to ensure that all possible options are investigated so we can find a vaccine, or combination of vaccines, that provide long-lasting safe protection for everyone.

“To help us make sure that the vaccines developed will work for everyone, we need people from all backgrounds to volunteer to take part in the vaccine trials.”

Chair of the Government’s Vaccine Taskforce, Kate Bingham said:
“The recent news about progress on the search for a vaccine is enormously exciting for the whole world, but we must not take our focus off continuing the important research to work out which vaccines work best for different people to provide long-lasting, effective protection against COVID-19.

“Many vaccines are needed both here in the UK, and globally, to ensure we can provide a safe and effective vaccine for the whole population. That is why the launch of this trial to establish the safety, effectiveness, and very importantly the durability, of the Janssen vaccine is so significant, and I would continue to encourage people to sign up and take part in vaccine trials.

“By co-funding this study we are helping generate data for future regulatory submissions internationally as well as for the UK."

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 UK public can support the national effort to speed up vaccine research and receive more information about volunteering for clinical studies by visiting www.nhs.uk/researchcontact to join the NHS COVID-19 Vaccine Research Registry.

To date, over 300,000 people have signed up to the NHS COVID-19 Vaccines Research Registry to take part in vital coronavirus vaccine studies. With a range of vaccine types needed to ensure people across the UK have access to one that works for as many people as possible, researchers are calling for volunteers to continue to sign up to take part in clinical studies. With several more phase 3 studies for potential vaccine studies 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. In particular the NHS COVID-19 registry needs volunteers who are most vulnerable to the effects of coronavirus, including frontline health and social care workers and people from Black, Asian and ethnic minority backgrounds.

The 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 2020. 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.