Latest COVID-19 Vaccine Booster Study Opens in Gloucestershire

We're pleased to be involved with this Sanofi vaccine booster study, which is open to people aged 18 years and above who have previously been fully vaccinated against COVID-19, not just the priority groups who are currently eligible for a booster on the national programme. Participants will need to have had their second dose of primary vaccine 4-10 months before their appointment, and appointments for this study will start at the end of November/ beginning of December at Gloucestershire Royal Hospital.

Around six hundred volunteers are set to be recruited to the study across the UK.

Participants at Gloucestershire Royal Hospital will receive a ‘booster’ vaccine to tackle COVID-19 infections, as part of an ongoing clinical study, run by the pharmaceutical company Sanofi with the adjuvanted recombinant COVID-19 vaccine they are developing in partnership with GSK.

The purpose of this study is to examine to what extent a single booster injection safely creates a broad immune response against the different COVID-19 variants, in participants who have previously been fully vaccinated with an authorized COVID-19 vaccine.

Participants will be asked to attend a minimum of six study visits, and their health will be monitored for 12 months. Those interested in volunteering for the trial can find out more by visiting the study website.

The study is open to adults aged 18-years-old and above, who have previously been vaccinated against COVID-19, with a licensed COVID-19 vaccination schedule. Participants need to have received their final dose of vaccine between 4 and 10 months ago. A broad range of people may be included, from those who are healthy to those with health problems that put them at risk for complications due to COVID-19.

Recruitment to the study has already begun in the United States, in Australia and France.

Those involved may contribute to the development of an additional vaccine that works for the good of global public health.

The first group of volunteers for the earlier phase of the study were vaccinated in October 2021, and a proportion of potential participants were identified through the NHS COVID-19 Vaccine Research Registry, which currently has over 515,000 people signed up.

To register interest in vaccine studies and sign up to be contacted by researchers, people can visit the NHS COVID-19 Vaccine Research Registry (www.nhs.uk/researchcontact).

Professor Adam Finn, Chief Investigator for the study said:

“Throughout the pandemic we have seen excellent engagement and participation from the public within multiple pivotal vaccine studies. By examining the safety and effectiveness of the booster vaccine from Sanofi, it’s hoped researchers and participants can help add another option to our current portfolio of vaccines.

“Booster vaccines from different suppliers will give us a broader range of vaccines and help us to reinforce supply as we look to boost immunity in the population going forward, as needed.”

Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, said:

“In addition to the several other COVID-19 vaccine studies running across the UK, this latest booster study from Sanofi will help inform future vaccine plans across the UK and beyond.

“As more of the population become fully vaccinated, research and studies such as this continue to strengthen our understanding of how we can help protect everyone against coronavirus moving forward.”

More information

There are expected to be around 630 volunteers across at 8 NIHR sites, including:

• Queen Alexandra Hospital Portsmouth (Wessex)
• Northwick Park Hospital (North West London)
• The Good Practice (GP practice, North West London)
• Rotherham Doncaster and South Humber NHS Foundation Trust
• Halton Hospital (North West Coast)
• Royal Marsden Hospital (South London)
• Gloucestershire Royal Hospital (West of England)
• Royal United Hospital Bath (West of England)

About the National Institute for Health Research

The mission of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research by:

• Funding high quality, timely research that benefits the NHS, public health and social care;
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
• Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.

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 rapidly over the coming months - potentially meaning 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.

More information can be found: NHS.UK/coronavirus