RSV Nasal Vaccine Study For Healthy Adults 60 to 75 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 about a new investigational nasal respiratory syncytial virus (RSV) vaccine that may offer protection from RSV. RSV is a common respiratory virus that can be very serious for infants and older adults. It is a leading cause of hospitalization for infants.
Who can participate?
Adults 60 to 75 years old who are generally healthy and interested in participating in a single dose RSV nasal vaccine study may be eligible to participate.
What will happen in the study?
The study includes 5 planned study visits and 2 phone calls over 6 months. You may be requested to come into our study center for visits outside of your scheduled visits, if you have any symptoms of RSV. Here are some of the things that will happen in this study.
You will:
- Complete a symptom diary to record any symptoms which occur prior to
trial vaccination, on the day of trial vaccination, 30 minutes after trial vaccination, and for 28 days after receiving the trial vaccine.
- Have a physical exam and tell us about your medical history.
- Submit blood and urine samples.
- Have nasal swabs.
- Receive one dose of the study vaccine.
(Given into the nose as a spray into each nostril)
You will be given a consent form that thoroughly explains all of the details of the study. 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 may or may not personally benefit from your participation in this trial. However, by taking part, you will help to provide new scientific information that will contribute to the development of RSV vaccines.
What are the bad things that can happen from this research?
As with any vaccine, you may have side effects. Expected side effects common from intranasal vaccines include runny nose/nasal congestion, sore throat, and cough. You may have discomfort from having blood draws and nasal swabs. We will discuss possible risks and discomforts with you prior to the start of the study.
Will you/your child be paid to be in this research study?
Participants will receive up to $1000 for time and effort to complete the study.