URMC to Test Stomach Bug Vaccine

Sep. 29, 2010
If Licensed, Vaccine Would be the World’s First against Norovirus
On cruise ships, tight quarters help norovirus spread quickly.

Starting this fall, University of Rochester researchers will recruit up to 90 local residents to help test a vaccine against norovirus, a common stomach bug long considered the bane of cruise ships, schools and daycare centers.

The virus – one of the main causes of gastrointestinal illness – leads to painful bouts of abdominal cramping, diarrhea and vomiting. Since the viruses can be transmitted by contaminated food, water, or simply by touching your hand to your mouth after contact with a virus-bearing surface, illness can spread like wildfire, especially when people live, work or learn in close quarters. Worst of all, these hardy viruses are tough to eradicate: they can withstand extreme hot and cold temperatures, as well as most disinfectants.

At present, no licensed vaccine exists against norovirus, but the company developing the trial vaccine – LigoCyte Pharmaceuticals of Bozeman, Mont. – has tasked URMC’s Chief of Infectious Disease John Treanor, M.D., with vaccinating dozens of adults to see if the shots produce a safe and effective immune response. (LigoCyte has also tapped researchers at Saint Louis University to participate in the study.)

Noroviruses afflict nearly 23 million Americans annually, and pose special burden to health care systems, businesses (in terms of employee sick days and missed work), and even military units (outbreaks can pose “readiness” issues for troops posted both on land and at sea). While the infection is usually short-lived in otherwise healthy people, select populations – including the young, the elderly, or people with other illnesses – can suffer from more severe complications, including dehydration and even death.

“Compared to diseases we already vaccinate against, norovirus infections are seldom fatal for most people,” Treanor said. “But the symptoms, which last a day or two, can be terribly uncomfortable and inconvenient – and there is always the risk of transmitting the virus to the more vulnerable members of our community.”

While flu viruses tend to cluster into a few dominant strains any given season, noroviruses come in more than a half-dozen circulating strains, or ‘serotypes.’ The soon-to-be-tested vaccine aims to protect against two key families of norovirus, which together cause the majority of norovirus disease worldwide.

“So many questions remain,” Treanor said. “One of the most pressing, assuming the shot is protective, is how long the immunity could last.”

To get at that answer and many others necessary to lead the vaccine to license, and perhaps later to market, the URMC research team is seeking almost 100 adult volunteers (48 volunteers age 18 to 49, another 20 volunteers age 50 to 64, and another 30 volunteers age 65 to 85).

Participants must not be pregnant, must be in good health, and would need to pass a basic health screening. Each would receive two doses of the norovirus shot, provide blood work and attend periodic follow up visits. Volunteers could receive up to $370 for completing all related visits and phone calls included in this study. Not all trials start immediately.

For further information about this trail or to enroll, call URMC’s Vaccine Research Unit at (585) 273-3990.