The misery of the common stomach flu may be over. The pharmaceutical company Moderna has launched a large Phase III trial to test a vaccine against norovirus, a frequent and sometimes dangerous source of food poisoning.
Modern ones Nova 301 test is scheduled to begin fully this year, after the first dose was given to a volunteer in September. About 25,000 volunteers over the age of 18 are expected to enroll in the randomized, double-blinded, and placebo-controlled trial, which will ultimately take two years to complete. People all over the world will be able to participate in the research, including many in the US
Norovirus is leading cause of foodborne illness in America, which amounts to 20 million cases per year. Most cases of norovirus are short-lived—if many are uncomfortable—with symptoms such as diarrhea, vomiting, and a flu-like illness lasting up to three days. For many, this is a miserable but manageable test. However, more people seek medical care, which leads to more than two million doctor visits and nearly half a million emergency room trips each year. In rare cases, the infection can be severe resulting in hospitalization or even death. About 100,000 Americans are hospitalized with norovirus, while 900 die from it each year. This is a fair one bigger issue in parts of the world with weaker sanitation and health programs.
“Norovirus is an important public health concern that affects millions of people worldwide every year, leading to severe symptoms and, in some cases, hospitalization,” said Stéphane Bancel, CEO of Moderna, in a statement last fall. “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, placing a significant burden on health systems worldwide.”
Although norovirus has long been a thorn in humanity’s side, the urgency for a vaccine is now even greater. After a brief hiatus throughout the pandemic, the norovirus is making a late comeback in the US. And it’s winter norovirus season is on the way which will be the worst experienced in more than a decade.
Scientists have struggling to improve a successful norovirus vaccine. Historically, we have not been able to grow the virus in the lab or in small animals, which has hindered our study of it. The virus is also naturally strong in our defenses. There are several types of norovirus that cause illness going around at any given time, and being recently infected with one strain does not necessarily protect you from others. Our natural resistance to a specific strain can also wear off over time, perhaps last for several months for others.
But recently, scientists have been able to create effective lab models for the study of norovirus, and they have developed some promising strategies for vaccination. Moderna’s vaccine candidate, for example, tries to create immunity by training the body to target virus-like particles (VLPs) that resemble norovirus but do not contain the actual virus. The candidate uses the same basic mRNA technology implemented in Moderna’s covid-19 vaccines to accomplish this. mRNA vaccines induce the body’s cells to produce a target protein that is then recognized by the immune system as a potential threat (in this case, the norovirus VLPs).
The company’s candidate is code-named mRNA-1403, and it is designed to induce immunity to at least three common types of norovirus, which is expected to ensure widespread protection. While norovirus is a terrifying experience for everyone, it tends to cause severe illness in vulnerable populations such as people with weakened immune systems and the elderly. That’s why most of the test volunteers (20,000) are over the age of 60. Some companies test themselves norovirus vaccines for children as well, however.
There are more than 250 study sites for Nova 301 testing worldwide, with more than 100 located in the US alone. Participants are required to be in general good health (this may include having well-controlled chronic health conditions), and with no recent history of gastrointestinal disease, among other criteria. The main part of the trial is planned to run for two years, with complete results expected in May 2027. Those interested in possible participation can take a survey conducted by Moderna HERE.