Does Respiratory Syncytial Virus (RSV) vaccine in pregnancy provide protection against RSV disease in babies?
RSV is the leading cause of lung disease in infants and young children. By the age of two, almost all children have been exposed to RSV. RSV illness early in life may also increase the chances of a child developing wheezing and asthma when they are older.
The Vaccine & Immunisation Research Group (VIRGo) at the Murdoch Children's Research Institute in collaboration with Melbourne Obstetricians are conducting a large study to find out whether giving an RSV containing vaccine (RSV F) during the last trimester of pregnancy is safe and will provide protection to the newborn baby against RSV disease.
What is the RSV vaccine in pregnancy study?
RSV vaccine in pregnancy is a large study to find out whether giving RSV F vaccine (against Respiratory Syncytial Virus) during the last trimester of pregnancy is safe and will provide protection in the newborn baby and young child against RSV compared to babies born to mothers who did not receive RSV F vaccine in pregnancy.
Why are we doing the RSV Vaccine in Pregnancy study?
Respiratory Syncytial Virus (RSV) is a common virus (germ) that is spread from person to person and can make both adults and children sick. Children with an RSV illness are most likely to have cold-like symptoms like cough, stuffy or runny nose, and breathing problems. These may lead to problems feeding, may make a baby fussy or feel really tired. In some children, RSV can cause severe lung disease such as bronchiolitis (damage to the small tubes that let air into and out of the lungs) and pneumonia (an infection in the lungs) and lead to hospitalisation or even death.
What does the study involve?
Our study team will see you and/or your baby a total of 14 times throughout the study: 5 times during your pregnancy (usually when you visit your obstetrician), once in hospital around the time of delivery and 8 times during your baby’s 1st year (usually at home).
You will be asked some questions about you and your pregnancy. We will check with your obstetrician and medical records to confirm the results of your pregnancy screening tests. You will receive 1 injection: RSV F vaccine or placebo (contains no medicine) in the last trimester of your pregnancy.
From you, we will collect 4 blood samples (before and 2 weeks after the injection, and twice after your baby is born). Following delivery, a blood sample will also be collected from the umbilical cord. Your baby will be monitored over their 1st year of life. He or she will have 2 or 3 blood draws. If your baby shows any symptoms suggestive of a RSV illness, you and your baby may need to provide a small sample from the nose or throat.
Join the RSV study
You may be eligible to participate in this RSV Study if you are a healthy 18-40 year old pregnant woman and your pregnancy screening tests have been normal.
If you would like to find out more about the RSV Study, please contact: (03) 8344 9325 or email@example.com
This study has been approved by The Royal Children’s Hospital Human Research Ethics Committee.