Vaccine Aims to Give the Heaves the Heave-Ho

May. 7, 2012
Researchers Test Vaccine Designed to Protect Against Cause of Stomach Flu

Rochester scientists are looking for 20 people willing to roll up their sleeves to test a vaccine designed to stop norovirus, the microbe behind most cases of what people commonly call stomach flu.

More than 20 million Americans each year are affected by norovirus, the leading cause of gastrointestinal illness in the United States. The illness causes bouts of abdominal cramping, diarrhea and vomiting. Usually the symptoms pass after a day or two, but more than 70,000 people in the United States are hospitalized each year because of the infection, according to officials at the Centers for Disease Control and Prevention.

While it’s often called the “cruise ship virus” because of some high-profile outbreaks in that setting, the virus runs through groups confined in close quarters in many settings, such as daycare centers, schools, nursing homes, prisons, and military barracks. It’s also the cause of the majority of food-borne illnesses in the United States.

“Norovirus is far and away the most common cause of short-term vomiting and stomach flu,” said John Treanor, M.D., chief of the Infectious Diseases Division, who is leading the research study at the University of Rochester Medical Center. “Getting infected with norovirus can be temporarily disabling – you really can’t do much of anything while you’re ill. Outbreaks can sweep rapidly through groups like military units or classrooms.”

Treanor’s team of doctors and nurses at the Medical Center is one of five groups across the nation testing the effectiveness of an experimental vaccine developed by Montana-based LigoCyte Pharmaceuticals, which is funding the study.

Treanor’s team has previously shown that the vaccine is generally well tolerated and provokes an immune response in people who received the vaccine. Late last year, other scientists showed that the vaccine, when given as a squirt up the nose, protects people against norovirus, but not as much as scientists would like. In the new study the vaccine will be given via a shot in the arm.

The virus is difficult to prevent because it is very hardy and has an ability to infect people that is nearly unrivaled in the world of infectious disease. Researchers have shown that just a few viral particles of norovirus can make someone sick – just a fraction of the thousands needed to cause infection with salmonella and many other infectious agents.

Right now, since there is no vaccine, the best protection against norovirus is to wash your hands as thoroughly as possible, especially if you are living or working with someone who is having symptoms like vomiting or diarrhea.

Scientists are still investigating how a vaccine might be used most effectively to protect people. For instance, since there are many types of norovirus, it’s possible that people would need to get vaccinated each year, much like they are with the flu vaccine, or every few years.

People taking part in the research study will receive two shots, four weeks apart – half the participants will receive the vaccine, and half will receive placebo shots. Four weeks after the second shot, participants will be exposed to norovirus to see if they are protected by the vaccine, and stay for five days in an isolation unit to prevent any spread of the virus to people not in the study. After that, participants will have a series of follow-up phone calls and visits for up to one year.

While five days in isolation can sound daunting, participants in similar studies have passed the time in a variety of productive ways. Participants work on scrap books, catch up on sewing projects, Skype with friends, play video games, paint, and practice musical instruments. In recent years, a popular activity has been readying resumes, applying for jobs, and scheduling job interviews once the study ends.

Payment for the study is $1,165 if all study visits are completed.

Healthy people between the ages of 18 and 50 may be eligible for the study. People not eligible include healthcare workers, daycare or school employees, and people who have regular contact with any of the following groups: pregnant women, children under the age of 5, or people over the age of 70.

In addition to Rochester, other sites for the study are Emory, University of Cincinnati, Baylor, and SNBL Clinical Pharmacology Center in Baltimore. 

For further information about this study or to enroll, call the Vaccine Research Unit at (585) 273-3990.