A Phase III clinical trial is being launched in the UK to investigate Moderna’s norovirus vaccine mRNA-1403.
This is the first vaccine trialled in the UK to target norovirus, a highly contagious virus that causes vomiting, diarrhoea, and stomach cramps. Often referred to as the “winter stomach bug”, it tends to spread during colder months. While norovirus affects people of all ages, vulnerable groups like the elderly can experience more severe illness.
The Phase III NOVA 301 trial (NCT06592794) aims to recruit 2,500 participants across 39 sites in the UK. Participants will be randomly assigned receive either mRNA-1403 or a placebo. Although anyone aged 18 or older who meets the inclusion criteria can participate, researchers are specifically focused on enrolling those aged 60 and older.
Norovirus puts the NHS under huge strain every winter, costing taxpayers around £100m ($129.75) annually, explained UK Health Secretary Wes Streeting. Sarah Collins, commercial director at the UK Health Security Agency 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.”
The trial is part of the ten-year strategic partnership between Moderna and the UK Health Security Agency (UKHSA) on behalf of the UK government. The UK Vaccine Innovation Pathway (VIP) and the National Institute of Health and Research (NIHR) are supporting the trial’s setup and delivery.
Moderna’s use of mRNA technology to stimulate immune responses has positioned it as a leader in the vaccine space, building on the company’s success during the Covid-19 pandemic. Moderna gained global recognition for its Covid-19 vaccine Spikevax, which secured regulatory approval in the UK in January 2021.
mRNA-1403 is a trivalent mRNA-based candidate containing mRNAs that encode for the major capsid protein 1 (VP1) of three globally prevalent Norovirus genotypes—GII.4, GI.3, and GII.3. Moderna shared data from the Phase I/II trial (NCT05992935) at IDWeek 2024, where the vaccine elicited robust serum HBGA-blocking antibody responses against all three genotypes and across all dose levels.
Alongside mRNA-1403, there are five other NoV vaccine candidates in late-stage development worldwide according to GlobalData’s pipeline product database. However, the virus’s broad and shifting genotype diversity and limited cross-genotype protection poses challenges for the development of an effective vaccine.
In August 2024, HilleVax slashed its workforce by 40% after its norovirus vaccine HIL-214 failed to meet key endpoints in its Phase IIb trial (NCT05836012) in infants. The company discontinued further development of HIL-214 in infants, but said it will explore the potential for continued development of HIL-214 and HIL-216, another vaccine, in adults.
