Earlier this week, Moderna announced it had dosed its first participant in the US with the company’s investigational norovirus vaccine, mRNA-1403, for its phase 3, Nova 301 trial.1
Norovirus is a contagious gastrointestinal virus, and is often referred to as the stomach bug. Symptoms for norovirus include vomiting, diarrhea, and stomach cramps.2
“Norovirus is a significant public health concern that affects millions of people worldwide each year, leading to severe symptoms and, in some cases, hospitalization,” said Stéphane Bancel, CEO of Moderna.1
People can contract norovirus by a few different means of transmission, including:
- Having direct contact with someone with norovirus, like caring for them, sharing food or eating utensils with them, or eating food handled by them.
- Eating food or drinking liquids that are contaminated with norovirus.
- Touching contaminated objects or surfaces and then putting your unwashed fingers in your mouth.2
What You Need to Know
Moderna has initiated the Phase 3 clinical trial for its investigational mRNA norovirus vaccine, mRNA-1403.
Norovirus spreads through direct contact with infected individuals, contaminated food, surfaces, or objects.
With no specific treatment available, preventive actions like proper handwashing, thorough cooking, and disinfection are crucial.
Trial Parameters
The Nova 301 Phase 3 trial is a randomized, observer-blind, placebo-controlled trial evaluating the efficacy, safety and immunogenicity of mRNA-1403. The trial aims to enroll approximately 25,000 participants 18 years of age and older globally, including in countries in the Northern Hemisphere (US, Canada, UK, Japan), the equatorial region, and the Southern Hemisphere (Australia and countries in South America).1
Approximately 20,000 participants 60 years of age and older and 5,000 participants between 18 and 59 years of age will be enrolled to assess the investigational vaccine’s ability to protect against moderate to severe norovirus acute gastroenteritis (AGE) in adults, with a focus on the older age group that is at greatest risk of severe outcomes including hospitalization.1
“By advancing our investigational norovirus vaccine into a pivotal phase 3 trial, we are one step closer to potentially providing a new tool to prevent infection from this highly contagious virus, which places a significant burden on health systems globally,” Bancel said.1
Prevention
There is no treatment for the virus, and it typically lasts 1-2 days. In order to try and prevent from contracting the virus, the Centers for Disease Control and Prevention (CDC) says people should do the following:
- Wash hands well and often
- Cook shellfish thoroughly and wash fruits and vegetables
- Clean and disinfect contaminated surfaces
- Wash laundry in hot water
- Stay home when sick for 2 days (48 hours) after symptoms stop2
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