Newcastle's Royal Victoria Infirmary to take part in UK's first-ever norovirus mRNA vaccine trial
by Nicole Goodwin · ChronicleLiveNewcastle's Royal Victoria Infirmary will take part in the UK's first norovirus mRNA vaccine trial, which is set to launch within the next two weeks.
The ‘Nova 301’ trial aims to recruit 2,500 participants in the UK between late October and early 2025. Applicants will be randomly assigned to two groups, with half receiving the investigational norovirus vaccine and the other half receiving a placebo. The total duration of trial participation will be approximately 25 months.
There are currently no licensed norovirus vaccines in use anywhere in the world. However, the trial, sponsored by Moderna, a pharmaceutical and biotechnology company, will evaluate the efficacy, safety and immunogenicity of an investigational norovirus vaccine, mRNA-1403.
The Phase 3 trial - called the ‘Nova 301’ trial - will take place at 39 sites, including Newcastle's Royal Victoria Infirmary.
Anyone aged 18 or older who meets all the eligibility criteria may be enrolled in the trial. However, researchers are seeking participants 60 years of age and older, as this age group of people are generally more likely to be severely affected by norovirus and so benefit most if the vaccine is shown to be effective.
The UK Chief Investigator is Dr Patrick Moore, a Dorset GP and Research Director at the NIHR’s South West Regional Research Delivery Network.
The trial is being run in the UK as part of a unique 10-year partnership between Moderna and the UK Health Security Agency (UKHSA) on behalf of the UK Government, the Moderna-UK Strategic Partnership. Set up and delivery of the trial is being supported by the UK Vaccine Innovation Pathway (VIP) [link] and the National Institute for Health and Care Research (NIHR), working together to accelerate vaccine trials in the UK.
The NIHR Research Delivery Network (RDN) is working with the devolved administrations to speed up the roll-out of key vaccine studies, through accelerated contracting and set-up. To maximise participation, the trial is making use of different recruitment strategies, including the NIHR’s flagship recruitment tool, Be Part of Research.
Be Part of Research is a free online service that matches people to health and care research across the UK. Anyone over the age of 18 can sign up for an account. When registering, people are asked what areas of research they are interested in, including vaccinations. They are then sent information about suitable studies taking place near them.
Dr Patrick Moore, co-director of Wessex Research Hubs and Chief Investigator of the trial in the UK, said: "The UK is really pleased to be able to play an important role in helping find an effective vaccine against this highly contagious disease. Outbreaks of norovirus have huge consequences, both on our health systems and our economy. This innovative trial is crucial in helping us advance healthcare."
Health and Social Care Secretary Wes Streeting said: "Norovirus is highly infectious and puts the NHS under huge strain every winter, costing taxpayers around £100 million a year. The UK is leading the way to develop a world-first vaccine for this vomiting bug, starting with this innovative vaccine trial delivered through the government-funded National Institute for Health and Care Research.
"Not only is this a huge vote of confidence in the UK’s life sciences sector, but a successful vaccine will help shift our health system away from sickness and towards prevention - reducing pressure on the NHS and keeping people well during the colder months."
NIHR Chief Executive and Chief Scientific Adviser to the Department of Health and Social Care, Professor Lucy Chappell said: "This novel vaccine could make a difference to the lives of many - especially our most vulnerable citizens - and reduce the burden of seasonal illness on the NHS. Leveraging the UK’s expertise in vaccine development, the DHSC through the NIHR and Moderna are delivering this large-scale trial at pace, so that people across the UK and the world can benefit sooner.
Dr Melanie Ivarsson, Chief Development Officer at Moderna said: "We are delighted to bring this trial to the UK - by advancing our investigational mRNA norovirus vaccine into a pivotal Phase 3 trial, we are one step closer to potentially providing a new tool to prevent infection from this highly contagious virus, which places a significant burden on health systems globally." highly contagious virus, which places a significant burden on health systems globally."
Sarah Collins, Commercial Director at the UK Health Security Agency, said: "Norovirus isn't just a nasty tummy bug – it can have serious consequences for vulnerable people, and cause a large amount of disruption in social care, hospital settings and education settings. It’s fantastic to see the first trial of its kind get underway as a result of UKHSA’s strategic 10 year partnership with Moderna, which aims to enhance investment in scientific research and vaccine development to enable a rapid response to future pandemics and other infectious diseases."
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