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UK’s first-ever norovirus mRNA vaccine trial launched
23rd October 2024
The first Phase 3 randomised clinical trial of an investigational mRNA norovirus vaccine will open across the UK within the next two weeks, it has been announced today
The trial, sponsored by Moderna, is evaluating the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, mRNA-1403. There are currently no licensed norovirus vaccines in use anywhere in the world.
The Phase 3 trial - called the ‘Nova 301’ trial - will take place at 39 sites, including 27 NHS primary and secondary care sites, and aims to recruit 2,500 participants in the UK between late October and early 2025.
Participants 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.
While anyone 18 years or older who meets all the eligibility criteria may be enrolled in the trial, 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 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), 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.
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.”
Scottish Cabinet Secretary for Health and Social Care Neil Gray said: “We’re pleased to be working with our colleagues across the UK on a potential world-first vaccine for norovirus. This is a highly contagious virus which places huge strain on our health service, particularly during winter months, and can cause severe illness for vulnerable members of our population.
“This important clinical trial can take us one step closer to potentially providing a new vaccine to prevent infection. It’s also important that NHS Research Scotland is involved as part of our ongoing efforts to advance healthcare and provide the latest treatment options for our patients.”
The study will be open in Scotland at Aberdeen Royal Infirmary (Grampian), Western General Hospital (Lothian) and Queen Elizabeth University Hospital (Glasgow).
Read the full release on the NIHR website.
