Clinical Trials / Research Studies
RSV Vaccine Study for Pregnant People 18-45 years and their Infants
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 the safety and duration of protection of the licensed RSV Vaccine ABRYSVO in pregnant people and the licensed RSV antibody BEYFORTUS (nirsevimab) in infants.
RSV (also called Respiratory Syncytial Virus) is a common virus that can make babies and small children very sick. There are two recently approved products that can help protect babies from RSV. One product is a vaccine called ABRYSVO. It is given to pregnant people. The other product is a monoclonal antibody called nirsevimab (BEYFORTUS). It is given to babies before or during their first RSV season.
Who can participate?
Pregnant people 18 years or older who are generally healthy and:
- Interested in participating in a RSV vaccine study
- Pregnant people between 20 - 36 weeks gestation and their infants
- Must plan to deliver at University of Cincinnati Medical Center or University of Cincinnati West Chester Hospital
Conditions
- Vaccines
- Pregnancy
- Adult Studies
What will happen in the study?
You will have about 7 in-person study visits (screening visit, enrollment visit, delivery visit, and 4 follow-up clinic visits). Your baby will have about 5 study visits (delivery visit and 4 follow-up clinic visits) through about 12 months after delivery. We may request that you come into our study center for visits outside of your scheduled visits if you have any severe symptoms. Here are some of the things that will happen in this study.
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.
- Have a physical exam and tell us about your medical history
- Submit blood samples
- Mother may receive one dose of the ABRYSVO RSV vaccine during pregnancy and your infant may receive one dose of BEYFORTUS at birth or at 3 months of age.
- Complete a symptom diary to record any symptoms which occur on the day of vaccination and each day for 7 days after vaccination of your infant
What are the good things that can happen from this research?
These study products have been licensed by the US FDA and have already been proven to reduce severe RSV disease in babies.
If you participate in this study, your baby will likely have a lower risk of severe RSV infection than babies who do not receive nirsevimab or whose pregnant mother was not vaccinated with a RSV Vaccine.
These study products are standard of care, and available to pregnant people and infants outside of the study, so the same benefit would be expected if either product were given inside or outside of the study.
This study will look at giving the approved RSV Vaccines given to both Mom and Baby and the protection from RSV during the first year of life. Knowledge gained from this study may be used to inform future policy recommendations about how to give RSV vaccines to pregnant people and their babies in the future.
What are the bad things that can happen from this research?
As with any vaccine, you may have side effects. Common side effects from vaccines include injection site redness, swelling or pain. You may also have discomfort from having blood draws. 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 $975 for time and effort to complete the study.
Contact
Maternal RSV Screener
Or contact:
Gamble Program for Clinical Studies
513-636-7699
gamble.program@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor
Rebecca Brady, MD
Infectious Diseases
Find More
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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