Yorkshire and Humber 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 Yorkshire and Humber, as the biotechnology company Moderna, Inc works with the National Institute for Health Research (NIHR).

The innovative study, which will take place at Bradford Teaching Hospitals NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, and Sheffield Teaching Hospitals NHS Foundation Trust, opens today and will see around 150 local participants receive a first or second booster.

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, University of London. The study is also open to people who are yet to receive their first booster dose - those who have received just two primary doses.

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.”

Moderna has stated that while a third shot of its original COVID-19 vaccine (also referred to as Spikevax) 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.

Stéphane Bancel, Chief Executive Officer of Moderna, said:

“The UK and NIHR have been pioneering in their work to study vaccines and therapeutics

throughout the global pandemic and have built-up world class clinical research capabilities.

“This is the first Moderna-sponsored Phase 3 study to be conducted outside of the U.S. with our Omicron-specific booster candidate and we appreciate the collaboration with the NIHR. We thank the clinical trial teams and the participants in the study for helping to advance our understanding of this booster candidate.

“We look forward to continuing our work with the NIHR and engaging further with the life-sciences community in the UK.”

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.

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.

Professor Simon Heller, Director of Research and Development, Sheffield Teaching Hospitals NHS Foundation Trust said:

“We feel privileged to once again be involved with a research trial which is at the cutting edge of how we respond to COVID-19 and its variations. By working together with Moderna, the NIHR and of course those amazing people who volunteer to participate in this research we can gather further vital information about Moderna's Omicron variant vaccine and the impact of a third or fourth dose.”

Dr Patrick Lillie, Consultant in Infectious Disease at Hull University Teaching Hospitals NHS Trust and Hon Senior Lecturer at Hull/York Medical School, is leading the trial at both hospitals. He said:

“This study is important as it will help answer the questions around fourth doses of vaccines, in particular, do they need to be adapted to Omicron or if the original vaccines still provide  a good response.”

Dr Catherine Cosgrove, Chief Investigator for the study and Infectious Diseases Consultant at St George’s University Hospitals, said:

"We know the impact to society and the huge costs to health that COVID-19 brings. Moderna’s Spikevax was the first COVID-19 vaccine to be in a clinical trial in the world and then authorised, with many millions now having received their vaccine globally.

"I am very excited to be leading this new study which looks into Moderna's Omicron variant vaccine and the impact of a fourth dose. We hope volunteers continue to step forward and help us show if additional boosters of Spikevax or the Omicron vaccine will increase protection."

Participants will be monitored throughout the study for any potential side effects and will have to attend to at least seven visits.