Doctors have begun testing the world's first vaccine against the vomiting bug norovirus, hoping it could bring significant health and economic benefits.
Norovirus causes illness and diarrhea and spreads very quickly between close contacts, with infections often occurring in hospitals, nursing homes, schools and daycares.
While most people recover within two to three days, the virus can be serious, especially in the very young, the elderly, or those with weakened immune systems.
There are currently no approved vaccines for norovirus in the world, while the sickest receive fluids intravenously, said Dr. Patrick Moore, a GP and national chief investigator in the United Kingdom.
Moore added that the burden of error is enormous, with 685 million cases and 200,000 deaths worldwide each year. There are thought to be around 4 million cases of norovirus a year in the UK, with around 12,000 hospital admissions a year in the UK alone.
“In the UK, norovirus is estimated to cost the NHS £100 million a year. [and] “If you take into account the loss of income, it amounts to around £300 million,” Moore said.
The phase 3 clinical trial, called Nova 301, will last two years and will involve 25,000 adults (focusing on those over 60 years of age) from countries such as Japan, Canada and Australia.
In total, 27 NHS primary and secondary care centers across England, Scotland and Wales will take part in the trial, recruiting around 2,500 participants from the end of October. The team added that they will also use mobile units to facilitate people's participation.
The UK arm of the study is part of the 10-year Modern-UK Strategic Partnership involving collaboration between the National Institute for Health and Care Research (NIHR), the Department of Health and Social Care (DHSC), the Agency for United Kingdom Health Security (UKHSA) and the pharmaceutical company Moderna, which manufactures the vaccine.
Within the trial, half of the participants will be randomly assigned to receive the new vaccine, while the other half will receive saline as a placebo.
The norovirus vaccine is based on mRNA technology, an approach used by companies such as Moderna and Pfizer/BioEntech in the development of their Covid-19 vaccines.
These vaccines work by introducing a single-stranded molecule (mRNA) into human cells. The mRNA contains instructions that this intracellular machinery can use to produce proteins associated with the virus. These proteins then stimulate the body's immune system, providing protection against future encounters with the virus.
In the case of the new vaccine, the mRNA contains instructions for making the protein coat of three different types of norovirus, creating harmless virus-like particles that can trigger the production of antibodies.
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While previous trials of the vaccine have shown that it produces a strong immune response in humans, the team said, the new trial is designed to examine whether the vaccine is effective against the virus and, if so, how long the protection lasts.
“At least 65% [efficacy] or more than we would consider clinically significant,” said Dr. Doran Fink of Moderna.
If the norovirus vaccine is successful, the company hopes to submit a marketing application to regulators in 2026, a review process that is expected to last up to a year. More trials will be done in adolescents and younger children.
Moore said a successful vaccine would help keep care homes running normally so people can visit their loved ones, while also helping prevent the frail, said Professor Saul Fast of the University of Southampton and co-clinical leader. of the NIHR Vaccine Discovery Pathway. of being weak.
“We wouldn't be doing this type of testing at this rate if it wasn't going to benefit individuals,” Faust said.
