RSV immunisation in pregnancy

RSV, or respiratory syncytial virus, is a virus that infects the lungs and breathing passages and can hospitalise young and premature babies through complications like pneumonia.

With almost every infant exposed to RSV by 2 years old, Mater Mothers’ is part of a clinical trial to see if a vaccine for pregnant mothers can protect newborns from the virus.

This trial aims to test the safety and efficacy of an investigational RSV vaccine given to women during their third trimester of pregnancy, to potentially protect their babies from RSV infections during their first winter. This vaccine enables a woman’s immune system to develop antibodies against RSV which are transferred through the placenta to her unborn baby - this is similar to how tetanus, influenza and pertussis vaccines work when given in pregnancy.


Why is this trial important?

RSV is a health issue worldwide and this vaccine may protect both women and babies from developing RSV illness. This is a Phase 3 Clinical Trial, which means that the vaccine has undergone previous trials that have gathered safety and immunogenicity data. Initial data on immune responses and antibody transfer across the placenta have been collected, but the vaccine is not yet commercially available.


Who can participate in the study?

Women who are:

  • 18-40 years of age
  • Have an expected delivery date before 30 June 2018
  • Are available for trial visits and telephone calls

Women cannot participate if they:

  • Have high blood pressure or pre-eclampsia in the current pregnancy
  • Have previously had a premature birth <34 weeks gestation
  • Have had more than 5 births
  • Have a serious medical problem such as cardiac, hepatic or renal dysfunction
  • Have a history of DVT, prior stillbirth or preterm delivery, acute disease or major  surgery

How does the trial work?

Participating women will be randomised into one of two groups:
The treatment group: will receive the RSV vaccine (two thirds of women)
The control group: will receive a placebo (one third of women)

  • One intramuscular injection will be administered during the third trimester of pregnancy
  • The process is blinded, which means neither the healthcare worker nor the patient will know to which group they have been assigned
  • Blood will be collected from the mother and her baby during the trial to assess the immune response to the vaccine and the survival of transferred antibodies in the baby.Mothers will have up to 6 blood draws over 9 months. Babies will have cord blood sampling at delivery and have 2-3 blood draws over 12 months of age.
  • Mother and baby will also be monitored by the Mater Mothers, Babies and Women’s Health team until the baby is 12 months of age.
  • Mater health professionals will see and check mother and baby whenever they have a cold or respiratory infection, and mucus samples will be collected to see if it is caused by RSV

For more information please contact:
Leisha Sandford, Research Nurse/Midwife
Phone 07 3163 1583; Study Mobile: 0481 781 716 Email: RSVstudy@mater.org.au

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