Clinical Trials / Research Studies
RSV Nasal Vaccine Study For Infants and Children
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 if an RSV (respiratory syncytial virus) study nasal vaccine is safe and could offer protection from serious RSV disease. RSV is a common respiratory virus that can be very serious for infants and older adults. It is one of the leading causes of hospitalization for infants.
Who can participate?
Infants and children who:
- Are 6 months to 59 months old who are generally healthy.
- Can complete either a single dose or 2-dose RSV nasal vaccine study.
- Would be available with a parent or guardian for study visits and phone calls over a 1-year period.
Conditions
- Vaccines
- Healthy Infants, Children and Adolescent Studies
What will happen in the study?
The study includes up to 10 planned study visits over 1 year. You may be requested to bring your infant/child into our study center for visits outside of their scheduled visits if they have any symptoms of RSV. Here are some of the things that will happen in this study:
- You will be asked about your infant/child’s health and any medications they take.
- Your infant/child will:
- Have a physical exam including temperature, pulse, respiratory rate, height, and weight.
- Have blood drawn during at least 5 visits.
- Have nasal swabs or nasal washes done during at least 4 visits.
- Receive either one or two doses of the study vaccine or placebo.
(Given into the nose as a spray into each nostril).
You will complete a symptom diary to record any symptoms your infant/child may have, which occurs 30 minutes after trial vaccination(s), and for 28 days after receiving the trial vaccination(s).
You will be given a consent form that thoroughly explains the details of the study. A member of the study staff will review the consent form with you and will answer all your questions.
What are the good things that can happen from this research?
Your infant/child may or may not personally benefit from their participation in this trial. However, by taking part, your infant/child 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?
Possible risks and discomforts will be discussed 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 $2,000 for time and effort to complete the study.
Contact
www.redcap.link/2023RSV
Or contact:
The Vaccine Research Center at Cincinnati Children’s
513-636-7699
VaccineResearch@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor
Paul Spearman, MD
Infectious Diseases
Cincinnati Children’s Hospital Medical Center
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3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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