Norovirus Vaccine Dose Challenge Study for Healthy Adults 18 to 49 Years Old
Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about what dose of norovirus causes infection in people and how safe the dose is. Symptoms of norovirus disease include vomiting, diarrhea and abdominal pain, and it is best known for infecting people on cruise ships.
Who can participate?
Healthy adults 18 to 49 years old who are willing to stay in an inpatient facility for up to 6 days, come in for 5 follow-up visits, and complete a final study contact may be eligible to participate.
What will happen in the study?
If you qualify and you decide to be in this study, you will be given a dose of norovirus to drink in a cup of water. You will be admitted to our inpatient research unit for up to 6 days and watched closely to see if you become ill. If you become ill, you will be cared for by our study staff and doctors at no cost to you.
Here are the other things that will happen in this study.
- Be asked about your medical history
- Have a physical exam
- Give samples of your blood, urine, saliva and stool
- Be asked to record the medicines you take, changes in your health, pregnancy, and medical visits after you leave the inpatient unit
- Come in for 5 follow-up study visits where you will bring in a stool sample
- Complete a final study contact
You will be given a consent form and a handout that details the study and payment. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
You will not receive a direct medical benefit from being in this study. When we complete this study, we hope that we will know more about norovirus infections which may help people in the future.
What are the bad things that can happen from this research?
The dose of norovirus you are given during the inpatient study could cause vomiting, diarrhea, and abdominal pain for several days. Other possible risks and discomforts will be discussed with those interested in learning more about the study.
Will you/your child be paid to be in this research study?
Participants may receive up to $2,500 for their time and effort.