Help to see if we can protect people against symptoms caused by the norovirus stomach bug with an investigational mRNA vaccine

Researchers at Royal Cornwall Hospitals NHS Trust, University Hospitals Plymouth NHS Trust and the NIHR Patient Recruitment Centre at Royal Devon University Healthcare NHS Foundation Trust 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 18 years of age or over, 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 7 scheduled clinic visits over that time.

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 Michael Gibbons, Joint Health and Care Director – Medical, at NIHR South West Peninsula Regional Research Delivery Network, 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/