One of the world’s first Omicron-specific variant vaccines is to be trialled in Devon and Cornwall, as the biotechnology company Moderna, Inc works with the National Institute for Health Research (NIHR).
The innovative study will see participants receive a first or second booster. In the South West, it is opening first at University Hospitals Plymouth NHS Trust, with plans to open at the Royal Cornwall Hospitals NHS Trust, and the NIHR Patient Recruitment Centre: Exeter at Royal Devon and Exeter NHS Foundation Trust later in March.
Half of the volunteers will receive a Moderna Omicron variant vaccine and the other half will be vaccinated with the commonly used standard Moderna COVID-19 vaccine (Spikevax).
This 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.
It 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.
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.”
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.”
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 Ray Sheridan, Principal Investigator for the study at the Royal Devon and Exeter NHS Foundation Trust, said: “We are excited that the Moderna vaccine updated for the Omicron strain is now ready for clinical trials in the UK and that we can now offer this study through the NIHR Patient Recruitment Centre: Exeter at RD&E supported by the NIHR Clinical Research Facility: Exeter.
“This trial is important as we still need to protect people against getting acutely ill with the Omicron variant of COVID as well as trying to prevent Long COVID from happening. This will help bring the pandemic under control and help everybody get back to living more normal lives again.”
Dr Claire Bethune, Principal Investigator for the study at University Hospitals Plymouth NHS Trust, said: “We are very excited to be able to recruit participants from the Plymouth area into this latest COVID-19 vaccine study. While COVID-19 continues to affect our lives in so many ways and new variants continue to emerge, it remains important to contribute to the work being done to develop new vaccines.”
Dr Duncan Browne, Principal Investigator for the study at the Royal Cornwall Hospitals NHS Trust, said:“We’ve seen how valuable vaccines are in the fight against COVID-19 but we have also seen the need for repeated booster vaccination. This study provides us with the opportunity to see vaccinations over time with modified vaccination targeting new variations of COVID.”
Volunteers aged 16 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 29 research sites across England and Wales and Scotland and last up to 13 months, and includes phone calls and visits to the research site.
Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme said: “The NIHR and research teams across the UK are eager to begin working with Moderna on this cutting edge vaccine study. There are currently a number of variant and multivariant targeting vaccines in development - this was always likely to be one of the next steps in COVID-19 vaccine research, however the emergence of the recent variants has brought forward this process.
“We have seen from the Omicron variant how some existing vaccines may protect less well against new variants, and continued research into which vaccine combinations work best is vital to help us stay protected. I am so grateful to those that have previously volunteered in vaccine studies, and sincerely hope that others will continue to step forward to help us understand this latest bespoke vaccine.”
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 at least seven visits.