The National Institute for Health and Care Research (NIHR) announced in October 2024 that the first Phase III randomised trial of an investigational mRNA norovirus vaccine is opening across the UK. The trial seeks to evaluate the efficacy and safety of mRNA-1403 and is sponsored by Moderna. It will be conducted across 39 sites in the country, including 27 NHS primary and secondary care sites. Investigators hope to recruit 2,500 participants between late October and early 2025.
Norovirus
Norovirus, or the “winter vomiting bug”, is a viral illness; it is the “most common cause” of acute gastroenteritis globally. Symptoms include acute onset diarrhoea and vomiting, but there is evidence to suggest that norovirus infection is associated with intestinal inflammation and malnutrition and could cause long-term morbidity. WHO estimates that 685 million cases of norovirus are seen each year, including 200 million cases in children under 5.
“The burden of norovirus is significant; norovirus causes an estimated 200,000 deaths per year, including 50,000 child deaths, primarily impacting low-income countries. Norovirus has been estimated to cost $60 billion globally as a result of healthcare costs and economic losses.”
There are no licensed norovirus vaccines in use.
The trial
Participants in the trial will be randomly assigned to two groups. One group will receive the investigational vaccine, and the other groups will receive a placebo. While anyone who is aged 18 or older and meets the inclusion criteria is eligible for the trial, researchers are seeking participants aged 60 and older. This age group is “generally more likely to be severely affected by norovirus”. Thus, a successful vaccine would be of greatest benefit to them.
The trial is part of the 10-year partnership between Moderna and the UK Health Security Agency (UKHSA) on behalf of the UK Government. It is supported by the UK Vaccine Innovation Pathway (VIP) and the NIHR, which are working together to accelerate vaccine trials in the UK. The NIHR Research Delivery Network (RDN) is working with the devolved administrations to accelerate the roll-out of “key” vaccine studies. These efforts include the NIHR’s flagship recruitment tool: Be Part of Research.
Be Part of Research is an online service that connects people to health and care research across the UK. Anyone over the age of 18 can register for an account, indicating the areas of research that they are interested in. They are then sent information about suitable studies.
Advancing healthcare
The UK Chief Investigator, Dr Patrick, is a GP in Dorset and Research Director at the NIHR’s South West Regional Research Delivery Network. Dr Moore commented that the UK is “really pleased to be able to play an important role” in finding a vaccine for 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.”
NIHR Chief Executive and Chief Scientific Advisor to the Department of Health and Social Care, Professor Lucy Chappell, hopes that the vaccine could “make a difference to lives of many – especially our most vulnerable citizens”.
“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.”
Health and Social Care Secretary Wes Streeting described the trial as a “huge vote of confidence in the UK’s life sciences sector”. It could also allow a “shift” away from sickness towards prevention, which would reduce pressure on the NHS and keep people healthier in the colder months. Moderna’s Chief Development Officer Dr Melanie Ivarsson is “delighted” to bring the trial to the UK.
“By advancing our investigational mRNA norovirus vaccine into a pivotal Phase III 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.”
Sarah Collins, Commercial Director at UKHSA, reflected that norovirus “isn’t just a nasty tummy bug – it can have serious consequences” including “disruption” to health services 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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