We are looking for pregnant women to take part in an important study to assess an investigational vaccine that may help provide newborn babies with protection against Respiratory Syncytial Virus (RSV) in the future.
RSV is one of the most common reasons babies are admitted to hospital, but there are currently no vaccines to prevent it or medications available to treat it.
What will researchers investigate?
Influenza and whooping cough (pertussis) vaccines are now routinely recommended during pregnancy to help protect newborn babies from serious infections.
Researchers will evaluate if giving an investigational vaccine to pregnant women may help protect their newborn babies against infections caused by RSV.
This study will involve up to 6900 pregnant women and their babies from different countries around the world.
What is RSV?
- RSV is a common virus that infects the airways and lungs.
- RSV can cause bronchiolitis (inflammation of the small airways of the lung) and pneumonia in babies and young children.
- RSV infections often requires 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
How does a vaccine in pregnancy work to protect my baby?
Vaccines given during pregnancy work by the mother making antibodies that are transferred through the placenta to help protect the baby during the first few months after they are born.
Is it safe?
This study has been approved by the ethics committees of the Monash Health and St John of God Health Care.
As of 28 February 2021, 2056 pregnant women have enrolled in the study. The RSV vaccine has also been given to over 1,300 adults aged 18 - 85 years in other clinical studies and there have been no safety concerns identified.
This trial is registered online at www.clinicaltrials.gov (NCT04424316)
Who can take part?
- Healthy women aged 18 to 49 years who are between 24 and 36 weeks pregnant are invited to participate.
- You are unable to take part if you have gestational diabetes, high blood pressure, a history of premature labour, you are expecting a multiple birth or your current pregnancy involved In Vitro Fertilisation (IVF). There may be other reasons that you cannot take part as well.
What does the study involve?
Participation in the study will last for up to 10 months for you and 24 months for your baby. The study will involve:
- Mothers will have 3 visits and babies will have 6 study visits. Study visits will be conducted at Perth Children’s Hospital or home visits may occur if required. The birth visit will occur at the hospital where you are delivering your baby.
- One dose of the RSV vaccine or the placebo vaccine (randomly assigned) during pregnancy.
- Two blood tests for you and collection of cord blood after delivery
- Follow-up of your baby throughout the study if they develop a respiratory tract infection, such as a ‘cold’ or chest infection. This will include a check-up with the study doctor 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.
Phone: 0439 783 610
Email: matisse@telethonkids.org.au