Published: 16 February 2022
The Vaccine Institute at St George’s, University of London and St George’s Hospital is leading on one of the world’s first Omicron-specific Covid-19 variant vaccine trials.
The innovative study, supported by the National Institute for Health Research (NIHR), opens this week at multiple sites across the UK and will see nearly 3,000 participants receive a first or second Covid-19 booster dose using Moderna vaccines.
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 puts St George’s at the forefront of research organisations working with industry, in collaboration with the NIHR, to improve health.
Dr Catherine Cosgrove, Chief Investigator for the study and Adult Lead at the Vaccine Institute at St George’s, 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."
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.
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.”
Health and Social Care Secretary Sajid Javid, added: “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.
The study will take place at up to 29 research sites across England, Wales and Scotland, with the trial lasting up to 13 months and including phone calls and visits to the research site.
To find out if you are eligible to join the study, you can visit the study’s website today.