- New government-funded clinical trials looking at different COVID-19 ‘booster’ vaccines set to launch in the UK
- Bradford will be one of 18 study sites across the UK
- Initial results trialling seven vaccines expected in September to inform plans for booster programme
- Announcements come ahead of International Clinical Trials Day (Thursday 20 May 2021)
THOUSANDS of volunteers will receive a booster COVID-19 vaccine in a new world-first clinical trial which launched in Bradford today.
The Cov-Boost study, led by University Hospital Southampton NHS Foundation Trust and backed by £19.3 million of government funding through the Vaccines Taskforce, will trial seven vaccines and will be the first in the world to provide vital data on the impact of a third dose on patients’ immune responses.
It will give scientists from around the globe and the experts behind the UK’s COVID-19 vaccination programme a better idea of the impact of a booster dose of each vaccine in protecting individuals from the virus.
Bradford has been chosen as one of 18 National Institute for Health Research (NIHR)-supported sites across the UK to take part. The team at Bradford Institute for Health Research (BIHR), based at Bradford Royal Infirmary, part of Bradford Teaching Hospitals NHS Foundation Trust, will roll out the study.
Bradford Teaching Hospitals’ Professor Alex Brown became the first in the world to take part in the study this morning (pictured).
The initial findings, expected in September, will help inform decisions by the Joint Committee on Vaccination and Immunisation (JCVI) on plans for a booster programme from autumn this year, ensuring the country’s most vulnerable are given the strongest possible protection over the winter period.
Health and Social Care Secretary, Matt Hancock, said: “The UK vaccination programme has been one of our nation’s proudest achievements in recent times, with seven in 10 UK adults now having had their first COVID-19 jab. It is vital that we continue to support the world-renowned British research sector that has contributed to its success.
“We will do everything we can to future-proof this country from pandemics and other threats to our health security, and the data from this world-first clinical trial will help shape the plans for our booster programme later this year.
“I urge everyone who has had both doses of a COVID-19 vaccine, and is eligible, to sign up for this study and play a part in protecting the most vulnerable people in this country and around the world for months and years to come.”
The trial will look at seven different COVID-19 vaccines as potential boosters, given at least three months after a second dose as part of the ongoing vaccination programme. One booster will be provided to each volunteer and could be a different brand to the one they were originally vaccinated with. Vaccines being trialled include Oxford/AstraZeneca, Pfizer/BioNTech, Moderna, Novavax, Valneva, Janssen and Curevac, as well as a control group.
Consultant Respiratory Physician Professor Dinesh Saralaya will be leading the booster trial in Bradford.
He said: “Once again this is great news for Bradford and our ‘City of Research.’ This new trial is to find how the various COVID vaccines work with one another so that we can be well prepared in the autumn when people are offered booster vaccinations.
“Participants will be given a different vaccine to the one they have been given already, and by mixing them in this way, we will find out which combinations are the most effective to give us continued protection against this deadly virus. As we know, vaccines are the only way of out this pandemic and research is vital in the hope of us getting back to normal.”
Professor Saralaya is now aiming to recruit 148 participants to the trial which will get underway in early June at the University of Bradford’s Digital Health Enterprise Zone (DHEZ) building.
The study will open for applications from volunteers shortly [via the study’s website] and will be recruiting participants through the NHS COVID-19 Vaccine Research Registry, with the trial set to start from the beginning of June.
Participants will be adults aged 30 years or older and will include those immunised early on in the vaccination programme – for example, adults aged 75 and over or health and care workers.
The trial was commissioned by the Department of Health and Social Care through the National Institute for Health Research (NIHR) and funded by the Vaccine Taskforce, with the study being undertaken by the Southampton team at sites across the UK as part of the National Immunisation Schedule Evaluation Consortium (NISEC).
The study will include a total of 2,886 patients across all 18 sites. All participants will be monitored throughout the study for any side effects and will have bloods taken to measure their immune responses at days 28, 84, 308 and 365, with a small number having additional blood tests at other times.
The team leading the trial is committed to including participants from a wide variety of backgrounds, and individuals from ethnic minorities are encouraged to apply to take part.
Chief Investigator and Director of NIHR Southampton Clinical Research Facility, Professor Saul Faust, said: “This trial will give the Joint Committee on Vaccination and Immunisation the important data to inform their recommendations of how to protect the population against any future wave.
“It is fantastic that so many people across the country have taken part in vaccine trials up to now so that we can be in a position to study the effects of boosters, and we hope that as many people as possible over the age of 30 who received their first dose early in the NHS programme will be able to take part.”
Minister for COVID-19 Vaccine Deployment, Nadhim Zahawi, said: “Having taken part in a COVID-19 vaccine clinical trial myself, I would encourage everyone eligible to volunteer – whatever your religion, ethnicity or background, it’s a fantastic opportunity to get involved with such an historic initiative.”
Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID-19 Vaccine Research Programme said: “Throughout the pandemic, the National Institute for Health Research, the NHS and all of our research partners have helped to rollout vital studies to help us learn how to treat COVID-19 and develop effective vaccines.
“The Cov-Boost study marks the next step forward in our efforts of understanding how to best protect the population and inform future vaccine booster programmes.
“Since the launch of the NHS COVID-19 Vaccine Research Registry, thousands of volunteers have been recruited to key vaccine studies, and we are confident we can call upon our nearly half a million strong community to help recruitment to this important trial.”