Clinical Trials / Research Studies
Clinical Trials / Research Studies

RSV Vaccine Study For Pregnant Women Between 24 to 36 Weeks

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to find out if giving expecting mothers an investigational vaccine for respiratory syncytial virus (RSV) is safe and could help protect their babies from RSV after they are born. RSV causes airway illnesses including bronchiolitis and pneumonia in children under 12 months.

Who can participate?

Pregnant women 18 to 49 years old who are between 24 to 36 weeks pregnant may be eligible to participate.

Conditions

  • Healthy Adults
  • Vaccines
  • Pregnancy

What will happen in the study?

The study includes 4 study visits over 12 months at Cincinnati Children’s. Here are some of the things that will happen in this study.

You will be assigned by chance (like flipping a coin) to receive RSVpreF vaccine or placebo. You will receive one of the 2 possible treatments (RSVpreF or placebo), with a 50% chance of receiving the study vaccine (RSVpreF) and a 50% chance of receiving the placebo. The “placebo” in this study is an injection that is like RSVpreF but does not contain any active ingredients.

Also, you will:

  • Be asked questions about your health
  • Have an external exam and vital signs taken
  • Have blood draws
  • Complete electronic diaries about how you are feeling
  • Be asked to take your temperature at home with a provided digital thermometer
  • Be asked to measure the size of any redness or swelling on your arm where the vaccine was given at home with a provided measuring device
  • Once your baby is born, bring in him/her for a routine newborn examination and study assessments
  • Be asked to contact the study team whenever you or your baby has a medical visit due to a respiratory tract illness, and to give updates about your and your baby’s health
  • 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?

    There may not be a direct benefit to you or your baby for taking part. However, you and/or your baby may indirectly benefit if, for example, you and/or your baby meet more frequently with healthcare providers. Also, the information learned from the study may help other people in the future.

    What are the bad things that can happen from this research?

    You may experience risks or discomforts when taking part in this study, which include some that are commonly observed with other vaccines such as injection site redness, swelling or pain, fever, tiredness, muscle pain or headache, some that are rare such as allergic reaction, including swelling of the face or lips (face edema) and shortness of breath, and some that are unknown at this time. Prior to participation, we will provide you with a complete list of risks or discomforts.

    Will you/your child be paid to be in this research study?

    Participants will receive up to $400 for time and effort.

    Contact

    Contact Us.Study Coordinator
    513-827-8363
    IDStudies@cchmc.org
    Cincinnati Children’s Hospital Medical Center
    3333 Burnet Ave.
    Cincinnati, OH 45229-3039

    Study Doctor

    Contact Us.Elizabeth Schlaudecker, MD, MPH
    Cincinnati Children’s Hospital Medical Center