- Norovirus is one of the most common causes of stomach bugs in the UK (1)
- There is currently no vaccine to protect against norovirus infection (2)
The Nova 301 trial is looking to recruit approximately 8,000 people globally to help see if an investigational mRNA vaccine can protect people against the symptoms caused by the norovirus stomach bug.
Researchers at Newcastle Hospitals 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 60 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 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 about 1 year, and participants must be willing to attend 3 to 4 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.
Dr Christopher Duncan, honorary consultant in infectious diseases at Newcastle Hospitals, 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.”
More information is available from Nova 301 trial team on 0191 282 0087 or by emailing [email protected]. The trial is taking place at the below location:
Newcastle Clinical Research Facility
Level 6, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
Moderna has provided editorial support for this press release.
