Vaccine Studies

Research Study for Healthy Adults 18 to 50 Years Old: Norovirus Vaccine Study

What is the purpose of this study?

Cincinnati Children’s Hospital Medical Center is conducting a research study, to test an investigational vaccine that may prevent a common infection known as norovirus disease. Norovirus infection is caused by a virus and causes symptoms like nausea, vomiting, diarrhea and stomach cramping.

Who will be included in this study?

Healthy adults between the ages of 18 and 50 years old who are willing to stay in an inpatient facility for at least 4 to 7 days may be eligible to participate. (People who work in restaurants and day care centers or who are direct-care workers/caregivers are not eligible for this study.) The first study group will be admitted October 2009 (with screening and first vaccinations in September.

What is involved?

The study involves two vaccinations 3 weeks apart followed by a 4-to-7-day-stay in an inpatient facility with private accommodations at Cincinnati Children’s. The following is a list of procedures that will take place during the study:

Participant will:

Be randomized (put into one of two groups by chance) to either receive two doses of the investigational intranasal (nasal spray) vaccine or the placebo (blank or no vaccine)
At least 3 weeks later stay in an inpatient facility at Cincinnati Children’s for 4 to 7 days
Be given a dose of norovirus germs (called a challenge) that could cause vomiting, diarrhea and abdominal pain for several days
Be assessed by a doctor throughout the stay
Have vital signs (temperature, blood pressure and heart rate) taken
Provide blood and stool samples
Have other outpatient visits and follow-up phone calls

What are the benefits?

There is no direct benefit to you for participating in this research study. However, your participation may help researchers better understand how to make a vaccine to prevent nororvirus infection and disease.

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin you have signed this form.

What are the risks and discomforts of the study?

While in this study, you may become ill from the dose of norovirus with typical symptoms including vomiting, diarrhea and abdominal pain for several days. As with all investigational vaccines, you may be at risk for some side effects. A detailed list of risks and possible side effects will be provided to those interested in knowing more about this study.