A randomised clinical trial of an mRNA vaccine against norovirus will be launched in the UK by the end of October 2024, it has been announced.
It will evaluate the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, mRNA-1403, which if successful could be the first licensed norovirus vaccine in the world.
The trial is sponsored by Moderna and will be conducted in collaboration with the UK Health Security Agency (UKHSA) on behalf of the UK Government.
It will use the Be Part of Research portal from the National Institute for Health and Care Research (NIHR) Research Delivery Network to help recruit volunteers.
In particular, researchers are seeking participants aged 60 years 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 NIHR said.
Some 2,500 participants will be recruited from across the UK between late October and early 2025, and will be given either a placebo or the investigational vaccine at one of 39 sites, including 27 NHS primary and secondary care sites.
Dr Patrick Moore, co-director of Wessex Research Hubs and chief investigator of the trial in the UK, said: ‘Outbreaks of norovirus have huge consequences, both on our health systems and our economy. This innovative trial is crucial in helping us advance healthcare.‘
Sarah Collins, UKHSA commercial director, added: ‘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.‘
Commenting on the clinical trial announcement, health and social care secretary Wes Streeting said the virus ‘puts the NHS under huge strain every winter, costing taxpayers around £100 million a year‘.
Finding a successful vaccine would ‘help shift our health system away from sickness and towards prevention – reducing pressure on the NHS and keeping people well during the colder months‘, Mr Streeting added.
And he described the trial as ‘a huge vote of confidence in the UK’s life sciences sector‘.
Meanwhile, Professor Lucy Chappell, NIHR chief executive and chief scientific adviser to the Department of Health and Social Care, said that the trial would be delivered ‘at pace, so that people across the UK and the world can benefit sooner‘.
mRNA vaccine trials are also underway for colorectal cancer, with trial sites across the UK including at Queen Elizabeth Hospital Birmingham.
A version of this article was originally published by our sister title The Pharmacist.
