UK’s first norovirus vaccine trial launched
The UK is about to embark on its first Phase 3 trial of an investigational mRNA vaccine aimed at combating norovirus, commonly known as the “winter vomiting bug.”
The trial, sponsored by Moderna, will evaluate the safety and efficacy of the vaccine, mRNA-1403, across 39 sites, including 27 NHS locations, and is expected to recruit 2,500 participants between October 2024 and early 2025.
The trial marks a significant step forward in the fight against norovirus, which has no licensed vaccine anywhere in the world.
With the virus responsible for approximately 3.7 million infections annually in the UK, the development of an effective vaccine could have far-reaching benefits.
Dr Patrick Moore, a Dorset GP and the UK Chief Investigator for the trial, highlighted the importance of this research:
“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 on our health systems and economy.”
The trial, part of a 10-year partnership between Moderna and the UK Government, will focus on participants aged 18 and older, with a particular emphasis on recruiting those over 60, a group more vulnerable to severe illness.
Volunteers will be randomly assigned to receive either the vaccine or a placebo and will be closely monitored over a 25-month period. The trial will include up to six clinic visits and several follow-up phone calls.
Moderna’s Chief Development Officer, Dr Melanie Ivarsson, commented on the trial’s significance:
“We are delighted to bring this trial to the UK. By advancing our mRNA norovirus vaccine, we are one step closer to providing a new tool to prevent infection from this highly contagious virus.”
Norovirus is responsible for around 685 million cases of gastroenteritis globally each year, significantly burdening healthcare systems.
In the UK alone, it costs the NHS over £100 million annually. The successful development of a vaccine could reduce both the economic and healthcare strains associated with the virus, particularly in winter when cases spike.
This Phase 3 trial represents a key milestone in vaccine development and is the result of the Moderna-UK Strategic Partnership, established in 2022 to enhance the UK’s mRNA research capabilities.
The collaboration also includes the construction of a new mRNA manufacturing facility at Harwell, which will be able to produce up to 250 million vaccines annually.
Health and Social Care Secretary Wes Streeting praised the trial as a vote of confidence in the UK’s life sciences sector, saying:
“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 towards prevention—reducing pressure on the NHS and keeping people well during the colder months.”
Participants interested in joining the trial can sign up via the Be Part of Research platform, a free online service that matches people with relevant health and care studies.
This innovative tool is being used to speed up recruitment and ensure the trial meets its goals.
The Nova 301 trial is expected to deliver significant insights into the prevention of norovirus, with hopes that a successful vaccine could be available for widespread use following regulatory approval.
For more information on how to participate in the trial, visit Be Part of Research.
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