Published: 16 February 2022
One of the world’s first Omicron-specific COVID-19 variant vaccines is to be trialled at multiple sites across the UK, as the biotechnology company Moderna, Inc works alongside the NIHR.
The innovative study, led by a team based at St George’s, University of London, opens this week and will see nearly 3,000 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 research organisations in the UK can provide to the life sciences industry.
Professor Lucy Chappell, Chief Executive of the NIHR, 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 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.
This is one of the first studies globally assessing the effectiveness of a fourth COVID-19 dose, however it is also recruiting people who are yet to receive their first booster dose - those who have received just two primary doses.
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.”
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.
The study will take place at up to 29 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.
The Moderna Omicron variant vaccine examined in the trial will also be used in a coinciding COV-Boost sub-study. The COV-Boost Omicron Variant Fourth Dose Booster Sub-Study will compare the results of Moderna’s Omicron variant vaccine with that of the standard Pfizer-BioNTech dose, both used as a 4th dose (second booster).
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 Adult Lead at the Vaccine Institute at St George’s, University of London and St George’s University Hospitals NHS Foundation Trust, 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.
“We are all so proud of the thousands of study volunteers in the UK that have come forward to help during this pandemic and without whom vaccine development would not have been possible.
"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."