Study Details
Revaccination in Subsequent Pregnancies with RSV Vaccine and Duration of Protection
(IRB#: IRB_00189564)
Respiratory Syncytial (sin-SISH-uhl) Virus, or RSV, is the leading cause of lower respiratory tract illness in babies and young children. RSVpreF is an approved vaccine to protect people and babies against RSV disease. When RSVpreF is given to pregnant women, it helps protect their babies against RSV disease in the first 6 months of life. It is unknown how long the protection will last from a single dose of RSVpreF. This study will test whether a second dose of RSVpreF when given in subsequent pregnancies is safe and can help produce antibodies that may protect the baby against RSV disease. Information will also be collected to learn whether a person still has antibodies from the past dose of RSVpreF given during the prior pregnancy. People in the study will be pregnant with unborn babies and non-pregnant. People will be divided into groups. One group gets one dose of RSVpreF. Another group will get either 1 does of RSVpreF or a placebo. A placebo looks like the drug but does not have the medication. Being in the study requires attending about 5 in person visits at the study clinic over up to 10 months. Medical tests will be done to track the health of participants.
- Female Only
- Under 7 or over 18 years old
- Healthy Volunteers
- In Person
- Paid
Who can participate?
Gender: Female Only
Age: Under 7 or over 18 years old
Volunteers: Healthy Volunteers
Location: In Person
Inclusion Criteria
- Ages 18 to 49 years and older
- Pregnant within a specific number of weeks
- Deliver the baby at a hospital or birth facility where study procedures will occur
- Non-pregnant who received a single dose of RSVpreF in previous pregnancy as part of a clinical trial
- Able to attend in person study visits
Exclusion Criteria
- Any medical or mental health condition within the prior year or active suicide thoughts/behavior
- Condition associated with prolonged bleeding
- History of severe adverse reaction associated with a vaccine
- Current pregnancy complications at the time of participation
- Any hypertensive disorder of pregnancy, including preeclampsia, eclampsia, gestational hypertension, or chronic (pre-existing) hypertension
Will I be paid for my time?
Yes
IRB#: IRB_00189564
PI: Torri Metz
Department: MATERNAL-FETAL MEDICINE DIV
Approval Date: 2025-10-16 06:00:00
Specialties: OB/Gyn, General, Women and Children's Health
I am Interested