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World-first Covid-19 vaccine booster study launches in the West Midlands

alternating
  • New government-funded clinical trial looking at different COVID-19 ‘booster’ vaccines launched today in the UK
  • Study will determine immune responses and reactogenicity from third dose of one of seven different vaccines
  • Initial results expected in September to help inform potential booster programme
  • People in the West Midlands are asked to sign up to the NHS vaccine registry at nhs.uk/researchcontact to hear more about this and other studies

Volunteers from the West Midlands will soon be able to receive a third ‘booster’ COVID-19 vaccine through a new clinical trial launching this week, the Health Secretary has announced.

The Cov-Boost study, backed by £19.3 million of government funding through the Vaccines Taskforce, will be run at University Hospitals Birmingham NHS Foundation Trust (UHB) and is being led by University Hospital Southampton NHS Foundation Trust. It will be the first in the world to provide vital data on the impact of a third dose on patients’ immune responses.

This will give scientists from around the world and the experts behind the UK’s COVID-19 vaccination programme a better idea of how effective a booster of each vaccine is in protecting the individual from the virus.

The initial findings, expected in September, will help inform decisions by the Joint Committee on Vaccination and Immunisation (JCVI) on any potential booster programme from autumn this year, ensuring the country’s most vulnerable are given the strongest possible protection over the winter period.

The trial will look at seven different COVID-19 vaccines as potential boosters, given at least 10 to 12 weeks 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. The trial has received ethics approval by the NHS Research Ethics Committee, as well as approval from the Medicines and Healthcare products Regulatory Agency.

Dr Chris Green, Consultant in Infectious Diseases at UHB, who will lead the trial in the West Midlands said:

“People in our region have already done so much to contribute to the Covid-19 effort. We are confident they will come forward to support us with this latest research which aims to inform the future vaccine strategy.”

The study will be recruiting participants through the NHS COVID-19 Vaccine Research Registry, with vaccinations 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 study will take place at 16 NIHR-supported sites across the UK, and will include a total of 2,886 patients. All participants will be monitored throughout the study for any potential 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. All sites will have an electronic diary for all participants that will send alerts to the team in real time if needed and a 24-hour emergency phone to a doctor on the study, who can provide further clinical advice.

All the trial sites are working on ways of including people in research from a wide variety of backgrounds and individuals from ethnic minorities are encouraged to apply.

The government is preparing for a potential booster programme based on clinical need and will publish further details in due course. The final policy will be informed by advice from the JCVI and take into account the results of clinical trials.

Professor Saul Faust, Chief Investigator and Director of NIHR Southampton Clinical Research Facility, 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.”

Rt Hon Matt Hancock MP, Health and Social Care Secretary, said:

“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 key part in protecting the most vulnerable for months to come.”

Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID 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."

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.”

Ends

Notes to Editors:

For more information, contact: Claire Hall, Communications Lead on 07775 800227 or claireanne.hall@nihr.ac.uk

Over 2,800 volunteers will be recruited from 18 research sites, including:

- University Hospitals Birmingham NHS Foundation Trust (UHB)
- University Hospitals Of Leicester NHS Trust
- Addenbrookes Hospital, Cambridge
- Stockport NHS Foundation Trust, Stepping Hill Hospital
- University Hospitals Sussex
- University College London Hospitals
- Royal Liverpool Hospital
- Northwick Park
- Guy's and St Thomas' NHS Foundation Trust
- Royal Devon and Exeter NHS Foundation Trust
- Oxford Vaccine Group
- University Hospital Southampton NHS Foundation Trust
- Royal Bournemouth Hospital - University Hospitals Dorset
- Portsmouth Hospital
- NIHR Patient Recruitment Centre Bradford
- Leeds Teaching Hospital
- NHS Greater Glasgow & Clyde Clinical Research Facility
- Public Health Wales - Wrexham

The trial was initially commissioned by the Department of Health and Social Care through the National Institute for Health Research (NIHR), with the study being undertaken by the Southampton team and sites across the UK as part of the National Immunisation Schedule Evaluation Consortium (NISEC).

Earlier this year, the government announced the launch of the ComCov clinical trial, which aims to determine the effects of using different vaccines for the first and second dose - for example, using Oxford/AstraZeneca’s vaccine for the first dose, followed by Pfizer/BioNTech’s vaccine for the second.

Initial results from this trial have shown that mixing the doses slightly increases the frequency of mild-to-moderate symptoms following vaccination, but there were no serious outcomes. Further results from this clinical trial are expected over the coming months.

· Volunteers can find out more about the study and sign up here: www.covboost.org.uk and https://www.nhs.uk/ResearchContact
· This will be a single-blind, randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of booster vaccination against COVID-19.

Overall, the UK has secured access to 517 million doses of eight of the most promising COVID-19 vaccines. These are:

o Pfizer/BioNTech for 100 million doses – including the additional 60 million doses for the revaccination programme
o Oxford/AstraZeneca for 100 million doses
o Moderna for 17 million doses
o Janssen for 30 million doses
o Novavax for 60 million doses
o Valneva for 100 million doses
o CureVac for 50 million doses
o GlaxoSmithKline and Sanofi Pasteur for 60 million dose

Volunteering for COVID-19 vaccine clinical trials:

People wishing to volunteer to support clinical trials can sign up for information on Covid-19 vaccine trials with the NHS Covid-19 Vaccine Research Registry, developed in partnership with NHS Digital. It is helping large numbers of people to be recruited into trials, meaning more effective vaccines for coronavirus can be found as soon as possible.

The service was commissioned as part of the UK Government’s Vaccine Taskforce in conjunction with the National Institute for Health Research (NIHR) and the Northern Ireland, Scottish and Welsh Governments.

Anyone living in the UK can sign up online to take part in the trials through the NHS, giving permission for researchers to contact you if they think you’re a good fit. Once you sign up, you can withdraw at any time and request that your details be removed from the COVID-19 Vaccine Research Registry. The process takes about 5 minutes to complete. Go to www.nhs.uk/researchcontact