A vaccine study for COVID-19 will open soon at Leicester’s Hospitals through the new Patient Recruitment Centre (PRC) in Leicester, which is a government funded initiative through the National Institute for Health Research (NIHR).
The global study, which is in phase three, will test the safety and effectiveness of a new two-dose regimen for a vaccine candidate for the prevention of COVID-19, which has been developed by Janssen, a pharmaceutical company owned by Johnson & Johnson.
This study will investigate a vaccine that uses a part of the coronavirus, called the spike protein, which the immune system will then recognise and fight should a real infection of COVID-19 occur.
It is expected that 30,000 participants will be recruited worldwide, of which 6,000 are expected to be recruited in the UK.
To take part in the study, participants need to be 18 years of age and older, with and without existing health conditions that are thought to be linked with increased risk of developing severe COVID-19 symptoms. The study will follow the participants for up to two years and three months for signs and symptoms of COVID-19 to determine how long protection lasts.
The PRC is one of five in England, dedicated to setting up and delivering late phase commercial clinical trials in the NHS at pace and scale. PRC Leicester is hosted by the University Hospitals of Leicester NHS Trust and based at Leicester General Hospital. The study is also being supported by the NIHR Clinical Research Network East Midlands.
Professor Melanie Davies, Clinical Director of NIHR Patient Recruitment Centre, Leicester said:
“We are pleased to be able to offer our local community the opportunity to take part in this important study, particularly when nationally there is a significant increase in cases of COVID-19 in the community and being treated in hospital.
“Having been under lockdown measures for a prolonged period, the people of Leicester will understand how important it is to find an effective vaccine so we can try to resume some normality and fight this virus.
“The expertise and hard-work from our staff has also allowed Leicester to shine as a global centre for research. The opening of this vaccine trial is another milestone in that success-story.”
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.”
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.
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 register your interest in the vaccine trial in Leicester email: ENSEMBLE2_Mailbox@uhl-tr.nhs.uk