Major COVID-19 vaccine trial opens in Scotland

16th November 2020

Hundreds of people from across Tayside and Fife are being sought to participate in a Covid-19 vaccine trial to be led by the University of Dundee and NHS Tayside.

From Monday (16 November), the University and health board will initiate the second Phase 3 clinical trial of a vaccine candidate developed by Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson.

Researchers are seeking 400 members of the public to volunteer for the study, which will see participants receive two injections of the trial vaccine within a two-month period. If successful, the vaccine could play a pivotal role in reducing Covid-19 rates around the world.

Professor Jacob George from the University of Dundee’s School of Medicine and R&D Director for NHS Tayside, said:

“It is a real testament to the R&D capability of the University and NHS Tayside to be selected to lead this trial in Scotland on behalf of Janssen Pharmaceuticals. Here we have the expertise and dedication to determine the efficacy of a vaccine that has the potential to help return the world to some semblance of normality again, but we cannot do this without the help of the public.

“While there has been some encouraging news this week about the development of a vaccine, it is widely acknowledged that we will need multiple vaccines if we are to bring this virus under control. This trial, therefore, is critically important and we are calling on people across Tayside and Fife to help us to potentially bring an end to this pandemic.”

Trial details

Participants will receive two injections of the trial vaccine, separated by a gap of 57 days. The vaccinations will take place at the Clinical Research Centre (CRC), located at Dundee’s Ninewells Hospital. Follow-up visits will either be at the Ninewells CRC or the Victoria Hospital in Kirkcaldy, whichever is closer to where the volunteer resides. Following their initial injection, participants will be asked to complete a daily diary via a mobile phone app, monitoring their response to the trial vaccine.

Researchers wish to recruit a representative sample from the entire population, however, women who are pregnant or aiming to become pregnant in the next ten months, as well as anybody on long-term steroids, are ineligible. Anybody at increased risk of contracting Covid-19 for any reason, including age, social situation or ethnicity, are particularly welcome to volunteer. People interested in volunteering can contact the research team via email at: TAY.ensemble2@nhs.scot

Dr Philip Short, Consultant Respiratory Physician at Ninewells Hospital, said:

“Our study gives the people of Tayside and Fife the opportunity to get involved in Covid-19 vaccine research. This is the first study using this potential vaccine to be trialled in the UK and focuses on the safety and effectiveness of the vaccine in tackling Covid-19. We would encourage anyone to get in touch with us about our vaccine study. Together we can help to eliminate Covid-19.”

Dr Gregor Smith, interim Chief Medical Officer for Scotland, said:

“This is the third vaccine trial to open in Scotland and is part of a portfolio of research studies to better understand the virus and drive progress in finding effective treatments, diagnostics and vaccines. Whilst recent developments on a potential vaccine are encouraging; we must make sure other clinical trials into Covid-19 vaccines and treatments continue.

“NHS Tayside, along with other sites across the UK, will be participating in the Janssen Covid-19 vaccine study using volunteers recruited through the NHS Covid-19 vaccine research registry. The ongoing commitment of research teams and participants, and the coordinated response to these studies via NHS Research Scotland is vital to drive further progress.”

A worldwide effort

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. The study will recruit up to 30,000 people worldwide, including six thousand across the UK, with study sites in 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.

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."  

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.”

NHS COVID-19 Vaccine Registry

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.

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

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