mRNA Norovirus Vaccine Candidate Launches Phase 3 Clinical Trial

Moderna, Inc. today announced that the first participant in the U.S. has been dosed in the Nova 301 Trial, a pivotal Phase 3 randomized clinical trial evaluating the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, mRNA-1403.

As of October 1, 2024, no U.S. FDA-approved norovirus vaccines are available.

"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, in a press release.

Enteric viruses, including norovirus, are a leading cause of diarrheal diseases, resulting in significant morbidity and mortality worldwide, particularly among young children and older adults.

Norovirus is highly contagious and a leading cause of diarrheal disease globally, associated with 18% of all AGE, resulting in approximately 200,000 deaths per year and substantial healthcare costs.

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 (U.S., Canada, UK, Japan), the equatorial region, and the Southern Hemisphere (Australia and countries in South America).

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 the highest risk of severe outcomes, including hospitalization.