A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization
This study is currently recruiting participants.
Trial website: https://clinicaltrials.gov/ct2/show/NCT02624947
Trial purpose: The aim of this study is to determine if giving RSV F vaccine during the last trimester of pregnancy is safe and will prevent severe lung disease caused by RSV in infants of mothers given the vaccine (via transfer of antibodies through the placenta to the baby) compared to infants born to mothers who did not receive RSV F vaccine in pregnancy.
Safety: To date, RSV F vaccine has been given to around 1,000 non-pregnant young women and has shown to be effective at increasing levels of antibodies to F protein of RSV. The RSV F vaccine has also been given to third trimester (7th to 9th month) pregnant women in the United States in one clinical study. A total of 50 pregnant women and their infants, 22 of these women received the active vaccine, 28 women received placebo. This study showed that pregnant women produce high levels of antibodies to the RSV F protein and that these antibodies were transferred to the baby while in the womb. Safety results showed that medical problems seen in mothers that received the vaccine, or their babies, were not different to medical problems seen in mothers that received placebo and their babies. (Section 9 of the main PIC from has more detail)
Recruitment: 8,255 healthy women will take part in this study in the USA, Australia, New Zealand, South Africa, Chile and Argentina. Around 300-500 mothers and their babies will be enrolled in New Zealand over a 4-year period.