Researchers at MFT investigating mRNA vaccine to protect people against symptoms caused by the norovirus stomach bug

Researchers at Manchester University NHS Foundation Trust (MFT) are recruiting people to take part in a clinical trial to see if an investigational vaccine (a vaccine that is being studied) may be able to protect people 18 years of age or older against the symptoms caused by the norovirus stomach bug. The investigational vaccine will be compared to a placebo jab (an inactive substance).

The Nova 301 Trial is a Phase 3 clinical trial. This is the last phase before an investigational vaccine can be made available for public use (after approval from the UK Medicines and Healthcare products Regulatory Agency). Phase 3 trials like this one evaluate the investigational vaccine in a large group of people.

People taking part in the Nova 301 Trial must be 60 years or older, be in good health and should not currently have a chronic gastrointestinal disease (including irritable bowel syndrome, colitis, oesophageal reflux, or any other medical condition with regular vomiting or diarrhoea).

Participants will receive either the investigational vaccine or a placebo jab (an inactive substance). The trial will last for up to 25 months, and participants must be willing to attend up to seven scheduled clinic visits over that time.

More information is available from Nova 301 Trial team based at Nowgen Centre at MFT’s Oxford Road Campus site via telephone: 0161 701 4737 or email: VaccineResearchTeam@mft.nhs.uk.

The Nova 301 Trial team will be on hand to support everyone who takes part in the trial. They will also make sure that participants understand the important details about the trial before agreeing to take part. This is called informed consent and includes what the trial involves and any risks.

Moderna, the company who has developed the investigational vaccine and the Nova 301 Trial programme, will reimburse participants for their trial-related time and expenses, for example, travel.

Professor Tim Felton, Consultant in Intensive Care and Respiratory Medicine is the Principal Investigator for the study at Manchester University NHS Foundation Trust. He said:

“Norovirus spreads very easily from person to person, via food or contaminated surfaces, so once it takes hold, it can be very difficult to get rid of, especially in settings like care homes, hospitals and schools. While most people recover well in a few days, more vulnerable groups are more likely to need medical support or higher levels of care.”

To take part in this trial visit: http://www.nova301trial.com/

The Nova 301 Trial is being supported by the National Institute for Health and Care Research’s (NIHR) Research Delivery Network at 27 NHS primary and secondary care sites, including MFT.

1. NHS Inform. Norovirus. Accessed June, 2024: https://www.nhsinform.scot/illnesses-and-conditions/infections-and-poisoning/norovirus/
2. Zhang, X. et al. Global Burden and Trends of Norovirus-Associated Diseases From 1990 to 2019: An Observational Trend Study. Public Health. 2022 Jun 17;10:905172. doi: 10.3389/fpubh.2022.905172.