We are looking for pregnant women to take part in an important study investigating a new vaccine that may provide newborn babies with protection against Respiratory Syncytial Virus (RSV).
RSV is one of the most common reasons babies are admitted to hospital and can lead to severe complications. Young babies are particularly vulnerable to RSV infections but there are currently no vaccines to prevent the virus or medications available to treat it.
What will researchers investigate?
Influenza and whooping cough (pertussis) vaccines are now routinely recommended for expecting mothers during pregnancy and have been proven to be an effective way to help protect young babies from these serious infections.
Researchers involved in this study will evaluate if giving an RSV vaccine during pregnancy will help provide babies with protection against the virus in their first few months of life.
What is Respiratory Syncytial Virus?
• RSV is a common virus that infects the airways and lungs. • The virus can cause bronchiolitis (inflammation of the small airways of the lung) and pneumonia in babies and young children. • RSV infections often require treatment in hospital as babies may require oxygen or have difficulty feeding. • In some cases, severe RSV infection in young children can cause wheezing or asthma later in childhood.
Who can participate?
Healthy women aged 18 to 40 years who are between 28 and 33 weeks pregnant are invited to participate.
You are unable to take part if you have gestational diabetes requiring medication, high blood pressure, a history of premature labour or you are expecting a multiple birth.
What does the study involve?
Your participation in the study will last for around 15 months and involve:
Nine visits to the study clinic located at Perth Children’s Hospital.
One dose of the RSV vaccine or the placebo vaccine (randomly assigned) during pregnancy.
Six blood tests for you and one blood test for your baby to assess immune responses to the vaccine. This will be performed by study staff who are very experienced in blood tests for babies.
Follow-up throughout the study period if you or your baby develop any respiratory tract illnesses. This may include check-ups with study staff and a nasal swab to test for respiratory viruses, including RSV.
Participation in the study is voluntary. Reasonable costs for your travel will be reimbursed.
Who to contact for more information?
Please contact the study staff at the Vaccine Trials Group - part of the Wesfarmers Centre of Vaccines and Infectious Diseases based at Telethon Kids Institute.