Six thousand UK volunteers from Monday 16 November will be called upon to join another leading phase three Covid-19 vaccine study.
Six thousand UK volunteers from Monday 16 November will be called upon to join another leading phase three Covid-19 vaccine study, as researchers around the world continue to work to secure a range of vaccines to help tackle coronavirus.
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 will recruit up to 30,000 people worldwide, with at least 500 people needed to take part at Plymouth’s Derriford Hospital.
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 begin taking part in the latest study at 17 National Institute for Health Research (NIHR) sites across the UK, including Plymouth, 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.
The study will be run by researchers at University Hospitals Plymouth NHS Trust, from the Derriford Centre for Health and Wellbeing, on the hospital grounds. Dr Claire Bethune, Consultant Immunologist at the Trust, will lead the study locally. She said: “This is a great opportunity for the people of Plymouth to contribute to the global effort against COVID-19. Anyone who is interested in signing up can contact us via email at email@example.com. It’s likely that we will need a range of treatments to prevent COVID-19 – some may work better for different scenarios. Trials like this are key in unlocking these potentials.”
Dr Gary Minto, Director of Research, Development and Innovation at University Hospitals Plymouth NHS Trust, added: “It is typical of the Plymouth community that so many people have already come forward to help, standing with the University Hospitals Plymouth staff in the fight against the Coronavirus. Our Research, Development and Innovation team are going above and beyond in order to make this possible. We are also seeing a big contribution from our pharmacy and laboratory team and student nurses from the University of Plymouth are also volunteering to help.
“It is important that people who are interested in participating are reassured that they will not be prevented from receiving a licenced COVID-19 vaccine should one become available during the course of the study.”
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. More than 1,300 people have signed up from Plymouth alone. 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 .
Business Secretary Alok Sharma said: “The start of further clinical trials in the UK is yet another step forward in the race to discover a safe and effective vaccine, and comes alongside recent news that we could be on the cusp of the first major breakthrough since the pandemic began.
“While we are optimistic with the progress being made, there are no guarantees and it is possible there will be no one-size-fits-all vaccine. That is why it is absolutely vital that while our scientists are cracking on with the job, we continue to follow the guidance to control the virus, protect the NHS and save lives.”
The UK government has developed a portfolio of six different vaccine candidates and secured access to 350 million doses to date. Of this, an agreement has been made in principle to include 30 million doses of the Janssen vaccine will be made available to the UK if it is safe and effective.
Professor Saul Faust, Professor of Paediatric Immunology and Infectious Diseases, University of Southampton and Chief Investigator for the Janssen Phase 3 study, said: “Finding an effective vaccine with a good safety profile is a top priority in helping to protect us all more quickly against Covid-19. While the news of a potential vaccine is tremendously exciting, our ambition in the scientific community is to ensure we leave no stone unturned in the search for a solution to help end this pandemic.
All the vaccines that are being trialled work by generating immune responses to the same part of the coronavirus as the RNA vaccine that has announced some interim early results.”
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.”
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.
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. 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.