The first Phase 3 randomised clinical trial of an investigational mRNA norovirus vaccine will open across the UK within the next few 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 over the next few months.
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. Researchers are seeking participants 60 years of age and older, as this age group is generally more likely to be severely affected by norovirus. Any future vaccine would benefit them most.
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."