Volunteers needed for Moderna Omicron COVID-19 vaccine study launching in Portsmouth
Volunteers from across Portsmouth will have the opportunity to take part in 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 Research (NIHR).
The innovative study, which will take place at the Portsmouth Research Hub, part of Portsmouth Hospitals University NHS Trust, will see around 100 local participants receive their first or second booster.
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 multiple COVID-19 variants) from Moderna.
Half of the volunteers will receive one of Moderna’s Omicron variant vaccines and the other half will be vaccinated with the commonly used standard Moderna COVID-19 vaccine (Spikevax).
The study is open to people who have already received a booster vaccine (Moderna or Pfizer/BioNTech). It is also open to people who are yet to receive a booster dose but have received two primary doses of either mRNA (Moderna, Pfizer/BioNTech) or non-mRNA (Oxford/AstraZeneca, Janssen) vaccines.
Volunteers must also:
- Be aged 16 years or over
- Have not tested positive for COVID-19 within 90 days of taking part in the study
- Have had their last vaccine at least three months prior to joining the study
Anyone interested in taking part can visit the study’s website to check if they’re eligible.
The study is the first commercially sponsored Moderna vaccine trial to take place in the UK, and demonstrates the appeal, support and expertise that 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.
Johanna Mouland, Research Nurse Lead at Portsmouth Hospitals University NHS
Trust, said:
“We’re pleased to be supporting another COVID-19 vaccine trial at the Portsmouth Research Hub, this time looking at the safety and effectiveness of Moderna’s booster vaccine.
“We’re proud of our role in tackling the pandemic and excited to provide another opportunity for the people of our city to support vital COVID-19 research.
“We’re looking for volunteers aged 16 and over, living in and around Portsmouth, to take part
in the trial. If you received your second or third dose of a COVID-19 vaccine at least 90 days ago, you may be eligible to take part.
“None of the research that we have supported throughout the pandemic would have been possible without our volunteers, who have so generously given up their time to help further our research.
“We’d encourage anyone interested in finding out more and getting involved in our latest
study to visit the website and sign up.”
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.”
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 and Wales and Scotland, with the trial lasting up to 13 months and including 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 several visits.
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 these latest bespoke vaccines.”
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.
"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."
