Maternal RSV Vaccine Study

What is RSV?

RSV, or Respiratory Syncytial (pronounced sin-sish-(e)-el) Virus, is a virus that infects the airways and lungs.

RSV is similar to the viruses that cause the flu or the common cold, RSV causes symptoms such as runny nose, cough and trouble breathing, and is extremely common.

Almost every infant is exposed to RSV by the age of 2. Many children experience mild symptoms that are mistaken for the common cold and get better without treatment.

Newborn babies 0-6 months of age  can develop more severe complications such as bronchiolitis (inflammation of the small airways in the lungs) or pneumonia and may require hospitalisation due to the infant not being able to feed or requiring oxygen. 

What is the study about?

The Maternal RSV Vaccine Study aims to determine whether an RSV vaccine given to pregnant women during the third trimester can protect newborn babies from RSV infections.

Similar clinical studies have given investigational vaccines to pregnant women and have been proven to protect newborn babies against tetanus, pertussis (whooping cough) and influenza. 

To help determine if the vaccine is effective against RSV some pregnant women will receive the RSV vaccine and others will receive a placebo vaccine.

Who can participate?

Participants MUST be:

• Aged 18 - 40 years; and
• Pregnant and due to give birth on or before 30 June 2018

Participants MUST NOT have:

• Experienced premature labour
• High blood pressue (or pre-eclampsia) during current pregnancy
• Had a pre-term birth in previous pregnancy
• Had 5 previous deliveries

What happens during the study?

The study will enrol pregnant women with an expected delivery date from 01 April - 30 June in 2018.

RSV is most abundant during the winter months, so infants born during this time are most at risk.  You will receive a single injection of either the investigational RSV vaccine or the placebo. Your baby does not receive the vaccine. Neither you nor your doctor will know whether you will be given the active vaccine or the placebo until after the study is completed.

What does the Maternal RSV Vaccine Study involve?

• To test the effectiveness of the vaccine, blood samples will be taken from both you and your baby. You will receive 5 blood tests over the course of 9 months, and your baby will receive 2-3 blood tests during the first year.
• Blood samples will be taken by experienced phlebotomists.
• The blood samples will be analysed to determine whether you and your baby have antibodies against RSV, which could indicate protection against RSV.
• You and your baby will also be monitored for signs of RSV infection.