Evaluating RSV immunity within Born in Bradford following the introduction of a national immunisation campaign

Background
Respiratory syncytial virus (RSV) causes a lung infection that leads to many children being admitted to hospital and dying across the world each year. A large number of children are hospitalised every year in the UK with RSV. Infants born early (prematurely) are at higher risk of needing medical care or dying as a consequence of RSV infections. Vaccines given to pregnant women to provide protection to their babies have been developed. These work very well at reducing disease in infants. However, it is not known how much premature babies are protected by these new vaccines, or how much babies are protected if the mother receives the vaccine earlier or later than is currently recommended. This study will try to answer those questions. I aim to do this by analysing blood and saliva samples in a laboratory to see if there are “markers” that show that someone has immunity against RSV. I will look at national hospital data (for example on numbers of children admitted to intensive care, or suffered from wheeze). I will analyse the data to see how well babies are protected by their mothers being vaccinated, and whether this is affected by being born premature.
Methods
This study has two main components, a laboratory study and a study of the full BiB datasets. The laboratory study will be based within the Born and Bred in study, an existing scientific study. Mothers already in this study will be offered the opportunity to join research focussing on RSV. Infants will be recruited to four groups: 1) Vaccinated before 32 weeks of pregnancy, 2) vaccinated at 32 weeks of pregnancy or after 3) Prematurely born infants and 4) Infants whose mothers haven’t been vaccinated. Infants have blood and saliva tests around birth and 6 months of life. They will have these samples tested for immunity against RSV using a range of laboratory tests, tested at the national UK Health Security Agency (UKHSA) laboratories. Information from the wider dataset of Bib participants will also be analysed. Using these data, the effectiveness of the vaccine to prevent severe disease and hospitalisation will be compared based on prematurity of the infant, timing of the vaccine in pregnancy. Short and longer term outcomes will be assessed. This study will be formally registered at the University of Oxford in collaboration with the Born and Bred In cohort, and the UKHSA.
Summary:
This study will focus on learning the best way to protect all infants, especially those born early, from getting sick with RSV. This will inform scientific understanding on how best to protect premature infants against RSV disease, and how the timing in pregnancy of vaccination impacts babies. This study will contribute to national and international policy on protecting infants against severe RSV disease.