North East study volunteers to receive Moderna Omicron specific COVID-19 booster vaccine

One of the world’s first Omicron-specific variant vaccines is to be trialled in Newcastle and Middlesbrough, as the biotechnology company Moderna, Inc works with the National Institute for Health Research (NIHR).

The innovative study, which will take place at the Royal Victoria Infirmary in Newcastle and the James Cook University Hospital in Middlesbrough, opens today and will see around 150 local participants receive a third or fourth dose at each site.

The first part of the study looked into the effectiveness of a tweaked Moderna vaccine targeting the Omicron strain, whereas this part of the study will further investigate a bivalent vaccine (one which targets multiple COVID-19 variants) from Moderna.

Half of the volunteers will receive a Moderna Omicron variant vaccine and the other half vaccinated with the commonly used standard Moderna COVID-19 vaccine (Spikevax).

It is the first commercially sponsored Moderna vaccine trial to take place in the UK and demonstrates the appeal, support and expertise the NIHR and other national research organisations in the UK can provide to the life sciences industry.

This is also one of the first studies globally to be assessing the effectiveness of a fourth COVID-19 dose, and is being led by a team based at St George’s Hospital. The study is also open to people who are yet to receive their first booster dose - those who have received just two primary doses.

Moderna has stated that while a third shot of its original COVID-19 vaccine increased neutralising antibodies against the Omicron variant at the lower half dose (used in the UK rollout), levels declined six months after the booster dose was administered. However, neutralising antibodies remained detectable in all participants.

Those enrolled who have already had a third dose (i.e their booster), must have received an mRNA vaccine (Moderna, Pfizer/BioNTech) as a third dose. Whereas those who have previously received two doses may have received mRNA (Moderna, Pfizer/BioNTech) or non-mRNA (Oxford/AstraZeneca, Janssen) vaccines.

Participants will need to have not tested positive for COVID-19 since the beginning of November 2021, and had their last vaccine at least three months prior to joining the study, which is recruiting for the next four weeks.

Dr Christopher Duncan, Honorary Consultant in Infectious Diseases and Principal Investigator for the study at The Newcastle upon Tyne Hospitals NHS Foundation Trust, said: “We are very pleased to be taking part in this new study in Newcastle. There is evidence to suggest that existing vaccines may not protect as well against new variants such as Omicron and it is important that we continue our research into how best to protect people from COVID-19.”

Dr David Chadwick, Research Lead for Infectious Diseases and Principal Investigator for the study at the South Tees Hospitals NHS Foundation Trust, said: “It is great that we can offer the opportunity to participate in another COVID-19 vaccine study to people from Middlesbrough and the surrounding area. I hope that volunteers will continue to come forward and help us with this research into whether booster doses of Spikevax or the Omicron vaccine can protect us better.”

Volunteers from 16 years old and above will be randomly selected to each arm of the study, and blinded to which they receive, with the study looking to evaluate the immune response and safety of the variant jab.

To find out if you are eligible to join the study, visit the study’s website today.

The study will take place at 30 research sites across England and Wales and Scotland, with the trial lasting up to 13 months and includes phone calls and visits to the research site.

Professor Lucy Chappell, Chief Executive of the National Institute for Health Research, said:
“The last two years have demonstrated the vital importance of international scientific collaboration.

"So it is truly exciting to see the NIHR and Moderna working with research teams across the UK on Moderna's first major UK COVID-19 vaccine study.

“With world-leading researchers, and the unique infrastructure and delivery expertise the NIHR provides, the UK is well-positioned to host exactly these sorts of significant, innovative
projects in a post-pandemic world.”

Health and Social Care Secretary Sajid Javid said:

“The UK is a world leader when it comes to the research and development of vaccines and medicines, bolstered by our renowned life sciences industry.

“It’s fantastic to see these capabilities being put to good use, with almost 3,000 people expected to take part in this important clinical trial. I want this country to be the best place in the world to launch clinical trials.

“I urge anyone eligible to take part in this vital research and play their part in protecting the country for years to come as we learn to live with COVID-19.”

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 additional 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.