East of England 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 the East of England as the biotechnology company Moderna, Inc works with the National Institute for Health Research (NIHR).

The innovative study, which will take place at Wansford and King’s Cliffe Practice, Peterborough, opens today (Wednesday 16 February) and will see around 100 local participants receive a first or second booster over the next four weeks.

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 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.

Dr Rhiannon Nally, GP at Wansford and King’s Cliffe Practice in Peterborough, who is leading the trial for the East of England region, said:

“We are delighted to be taking part in the Moderna Omicron vaccine trial. We see this as crucial research in the fight against Coronavirus as we acknowledge that we all have to learn to live with it and be able to respond to emerging new strains quickly.”

Dr Amrit Takhar, NIHR Clinical Research Network Primary Care Lead for the East of England region, said:

“It is thanks to the generosity of those who have volunteered to participate in trials, along with the incredible efforts of our research community, that we have managed to find the vaccines and treatments we have so far.

“However, we still have answers to find to make sure we can continue to protect everyone, everywhere, as much as possible, which is why this trial testing a vaccine for the Omicron variant is so important.

Volunteers who have already had a third dose (i.e their booster) must have received an mRNA vaccine (Moderna, Pfizer/BioNTech) as a third dose in order to be able to join the trial. Whereas those who have previously received two doses may have received mRNA 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 should have had their last vaccine at least three months prior to joining the study.

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 at https://connect.trialscope.com/studies/7dff1448-9e85-4beb-81a4-ec4f9170c769 and on the NHS COVID-19 Vaccine Research Registry website at https://www.nhs.uk/ResearchContact.

You can also call the Research Team at Wansford and King’s Cliffe directly on 01780 781623 / 01780 408001, or email their Research Coordinator at laura.costello3@nhs.net.

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.

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.

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