UK's first norovirus mRNA vaccine trial launched

The first Phase 3 randomised clinical trial of an investigational mRNA norovirus vaccine will open across the UK within the next two weeks. 

Sponsored by Moderna, the trial evaluates the efficacy and safety of a norovirus vaccine called mRNA-1403. There are currently no licensed norovirus vaccines in use anywhere in the world. 

The Phase 3 trial will take place at 39 sites across the country. This includes 27 NHS primary and secondary care sites. It aims to recruit 2,500 participants in the UK between late October and early 2025. 

Participants will be randomly assigned to two groups. Half will receive the investigational norovirus vaccine and the other half will receive a placebo. Anyone 18 years or older who meets all the inclusion criteria is eligible for the trial. But researchers are seeking participants 60 years of age and older. This older age group of people is generally more likely to be severely affected by norovirus. Any future vaccine would benefit them most.

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) and the NIHR. They are 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. They do this through accelerated contracting and set-up. The trial is making use of different recruitment strategies. This includes using 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.”

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."

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.”

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.”

What is norovirus?

Norovirus, also called the "winter vomiting bug", is a highly transmissible stomach bug that causes vomiting and diarrhoea. It's usually caused by a viral or bacterial infection and can affect people of all ages, and peaks in the winter months.

A key impact of norovirus on society is the disruption outbreaks cause. This includes:

• work and school absences
• the extra pressures placed on health and social care services because of closures and staff sickness.

It is especially active during the winter. Some groups, including the elderly, experience more severe illness. According to the United States’ Centers for Disease Control and Prevention (CDC), norovirus causes about 1 in 5 cases of acute gastroenteritis worldwide. It causes an average of 685 million cases of acute gastroenteritis each year, including 200 million cases in children under five. It is estimated to cost $60 billion worldwide due to healthcare costs and lost productivity. 

In the UK, it has been estimated that norovirus costs the UK National Health Service (NHS) more than £100 million annually. A 2017 data re-analysis estimated that the norovirus burden in the UK was around 3.7 million infections each year. 

About the trial

The Nova 301 trial is a Phase 3 randomised, observer-blind, placebo-controlled trial evaluating the efficacy, safety and immunogenicity of mRNA-1403. The trial aims to enrol approximately 25,000 participants 18 years of age and older globally. This includes countries in the Northern Hemisphere (U.S., Canada, UK, Japan), the equatorial region, and the Southern Hemisphere (Australia and countries in South America). Approximately 20,000 participants 60 years of age and older and 5,000 participants between 18 and 59 years of age will be enrolled. The aim is to assess the vaccine's ability to protect against moderate to severe norovirus acute gastroenteritis (AGE) in adults.

The Phase 3 trial will evaluate the investigational vaccine in a large group of people. Participants are selected randomly to receive either the investigational vaccine or a placebo jab. First, potential recruits are screened to confirm if they are eligible. Those able to take part will have up to six further in-person clinic visits. The single dose vaccine is received at the first visit - a jab given in the upper arm. The trial lasts up to 25 months. Anyone taking part must be at least 18 years old and in good health. The trial lasts approximately two years year and includes at least six in-person visits to the clinical trial site and five phone calls with the trial team.

A Phase 3 study is typically the final phase in the clinical trial process. If the Phase 3 trial shows that the vaccine is safe and effective, the results are submitted to regulatory agencies, like the MHRA in the UK, for approval. This is the final step before the vaccine can be made available to the public.

About mRNA vaccines

mRNA, or ‘messenger ribonucleic acid’, forms part of every human cell. It is the way in which the instructions in our genes (DNA) can are used to make certain specific proteins. When used in vaccines, mRNA delivers the instructions for replicating proteins identical to ones found in a particular virus. Once replicated, our immune system will recognise it as a foreign body and produce antibodies that will attack the protein if they encounter it in an actual virus.

Read more about what mRNA vaccines are on the UKHSA website.

About the Moderna-UK Strategic Partnership (MSP)

This pioneering clinical trial is part of a unique collaboration between Moderna and the UK Government together with the National Institute for Health and Care Research (NIHR). 

The UK government entered a 10-year partnership with Moderna in December 2022 to onshore mRNA capability in the UK and build resilience in the event of a new health emergency. The partnership includes the building of a mRNA manufacturing facility in Harwell, which will create more than 150 highly skilled jobs and have the capacity to produce up to 250 million vaccines per year in the event of a pandemic. The partnership is managed by the UKHSA on behalf of the Department of Health and Social Care. 

The NIHR’s Vaccine Innovation Pathway (VIP) is playing a crucial role in accelerating vaccine development and clinical trial delivery. It brings groundbreaking science closer to the public faster than ever before.

The Moderna/NIHR partnership aims to bring innovative vaccines to market faster, leveraging the UK’s world-class clinical research infrastructure. With the NIHR’s VIP driving the initiative, the Nova 301 trial serves as a model for future collaborations between the public and private sectors in advancing medical research.

For more information, read our blog about the Vaccine Innovation Pathway.