Moderna Begins Phase 3 Trial for mRNA Norovirus Vaccine

Moderna, Inc. has announced the commencement of dosing the first participant in the United States for its Nova 301 Trial. This significant Phase 3 trial is set to evaluate the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, known as mRNA-1403. The global recruitment process for this trial has also been initiated.

Stéphane Bancel, CEO of Moderna, emphasized the importance of addressing norovirus, which poses a major public health challenge affecting millions globally each year. The virus often leads to severe symptoms and can sometimes result in hospitalization. With the launch of this pivotal Phase 3 trial, Moderna hopes to bring a new preventive measure against this highly contagious virus, which imposes a heavy burden on healthcare systems worldwide.

The Nova 301 trial is structured as a randomized, observer-blind, placebo-controlled study. It aims to enroll approximately 25,000 participants aged 18 and older from various regions including the Northern Hemisphere (U.S., Canada, UK, Japan), the equatorial zone, and the Southern Hemisphere (Australia and countries in South America). The trial will focus particularly on older adults, with about 20,000 participants aged 60 and over and 5,000 participants between 18 and 59 years old. This demographic is of particular interest as they are at higher risk of severe outcomes, including hospitalization, from moderate to severe norovirus acute gastroenteritis (AGE).

Norovirus and other enteric viruses are major contributors to diarrheal diseases, causing significant illness and death worldwide, especially among young children and the elderly. Norovirus itself is highly contagious and is responsible for 18% of all cases of acute gastroenteritis globally, leading to roughly 200,000 deaths annually and incurring substantial healthcare costs.

The investigational vaccine, mRNA-1403, is designed as a trivalent formulation. It contains mRNA that encodes for virus-like particles (VLPs) aimed at providing protection against multiple norovirus genotypes. The goal of this vaccine is to prevent moderate to severe cases of acute gastroenteritis caused by norovirus.

Moderna has established itself as a leader in the field of mRNA medicine, transforming the way medicines are developed and used to treat and prevent diseases. The company has leveraged mRNA technology to create treatments with remarkable speed and efficiency, including one of the most effective COVID-19 vaccines.

Through its innovative mRNA platform, Moderna has developed therapeutics and vaccines for a range of conditions, including infectious diseases, immuno-oncology, rare diseases, and autoimmune disorders. The company is driven by a unique culture and a global team committed to making a significant impact on human health through mRNA medicines.

Moderna's journey in mRNA technology has been marked by rapid advancements and a commitment to addressing pressing health challenges. With the Nova 301 trial, the company continues to push the boundaries of what is possible in vaccine development, aiming to provide new solutions for global health issues like norovirus. As the trial progresses, Moderna remains focused on delivering impactful medical innovations that have the potential to protect and improve the lives of millions around the world.