Moderna Omicron vaccine booster study expands in London, targeting multiple COVID-19 variants

Volunteers from across London have the opportunity to join one of the world’s first Omicron-specific COVID-19 variant vaccine studies, as biotechnology company Moderna, Inc works with the National Institute for Health and Care Research (NIHR).

The innovative study, taking place at Barts Health NHS Trust, Royal Free NHS Foundation Trust and University College London Hospitals NHS Foundation Trust, will see participants aged above 16 receive either a first or second booster (i.e. a third or fourth Covid vaccination).

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 the original and the Omicron variants) from Moderna.

Across the CRN North Thames region, which encompasses these three London NHS trusts, half of the volunteers will receive the bivalent vaccine and the other half 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 (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.

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 in the last three months, and to have had their last vaccine at least three months prior to joining the study.

Dr Fiona Burns, leading the study for the Royal Free Hospital, said: “We are delighted to have taken part in this vaccine research. Although COVID-19 vaccines have been hugely successful it’s important we develop vaccination plans that continue to provide protection from different strains of the virus.”

Dr Tommy Rampling, principal investigator of the study at UCLH, said: “This important study will indicate how much protection this vaccine offers against the Omicron variant, and give us vital data on the impact of a fourth dose of vaccine. We are grateful to all participants who are signing up to take part in this study.”

Professor Anju Sahdev, who is leading the study at Barts Health, added: “We encourage people from our east London population – and beyond - to investigate if they are eligible for this important study. Increasing the protection for our population is a priority for Barts Health.

“We want as many people to be protected from different variants of COVID-19 as possible.”

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.

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